Regulatory

Aspen Neuroscience

Director, Regulatory Affairs - CMC

The Director of Regulatory Affairs, Chemistry Manufacturing Controls (CMC) provides strategic leadership and functional ownership for global CMC regulatory activities supporting the Company’s cell therapy products and associated delivery devices from clinical development through marketing application, commercialization readiness, and lifecycle management. This role establishes and directs CMC regulatory strategy for assigned programs and focus areas and serves as the senior CMC regulatory advisor to executive and cross-functional leaders. The Director is accountable for regulatory decision quality, health authority engagement, organizational alignment, and the management of significant CMC regulatory risks, policies, priorities, resources, and deliverables that affect program and departmental success. This is a Hybrid or Remote role that requires flexibility and availability for weekend and holiday work as needed. Relocation is not available.

**DUTIES AND RESPONSIBILITIES:**

- Own and Direct CMC regulatory strategy for assigned cell therapy products, associated delivery devices, and regulatory focus areas across clinical dev, marketing application, commercialization readiness and lifecycle mgmt.
- Translate company and functional objectives into integrated CMC regulatory plans, decision frameworks, operating priorities, resource requirements, and measurable deliverables; make final recommendations on methods, approaches, and evaluation criteria within the assigned scope.
- Lead the planning, preparation, review, and submission of high-quality CMC content, including IND Module 3, IMPD, briefing materials, responses to information requests, amendments, annual reports, and applicable marketing application, and lifecycle content.
- Establish CMC regulatory positions and precedents by interpreting evolving global requirements, guidance, industry trends, and agency expectations for cell and gene therapies, biologics, and medical devices; translate developments into program and policy recommendations.
- Direct the Identification, assessment, communication, and mitigation of significant regulatory risks, uncertainties, and interdependencies; develop practical contingency strategies and escalate critical matters with clear business and regulatory recommendations.
- Provide senior level regulatory direction for change controls, deviations, comparability, specifications, validation, stability, and GMP or quality investigations throughout development and commercialization readiness.
- Lead CMC interactions and negotiations with FDA and other global health authorities, including meeting strategy, briefing packages, response positions, negotiation parameters, commitments, and follow-through.
- Serve as the senior CMC regulatory advisor to Technical Operations, Manufacturing, Process Development, Analytical Development, Quality, Clinical, Nonclinical, and other partners; resolve competing priorities and build alignment on matters significant to program and company objectives.
- Represent Regulatory Affairs in cross-functional governance and planning forums, communicate complex issues and recommendations to senior leadership, to enable timely, well-informed decisions.
- Establish and oversee CMC regulatory operating plans, submission schedules, budgets, priorities, quality standards, processes, and internal and external resource models; strengthen inspection and submission readiness, knowledge management, and execution effectiveness to meet corporate requirements.
- Direct the work of employees, consultants, vendors, partners, and collaborators supporting CMC regulatory deliverables; define expectations, evaluate quality and performance, and ensure accountability for outcomes.
- Build regulatory capability through people leadership, coaching, succession and development planning, and oversight of project contributors; foster a collaborative, accountable, and high-performing team culture.

**EDUCATION AND EXPERIENCE:**

- Bachelor's degree in Life Sciences, Pharmacy, Engineering, or a related scientific discipline required; advanced degree preferred.
- Minimum of 10 years of progressively responsible regulatory affairs experience within biotechnology, pharmaceuticals, medical device, or related industries, including significant CMC regulatory experience.
- Experience independently leading global CMC regulatory strategy and content for INDs, CTAs, and major health authority interactions required; experience supporting BLA, NDA, MAA, or equivalent marketing applications strongly preferred.
- Biologics experience required; cell or gene therapy experience strongly preferred. Medical device experience preferred.
- Experience interacting with global health authorities and leading cross-functional regulatory initiatives preferred.

**JOB SPECIFICATIONS:**

- CMC Regulatory Expertise: Advanced knowledge of global CMC regulations, guidance, and agency expectations, including FDA, EMA, MHRA, Health Canada, and ICH requirements applicable to biologics and advanced therapies.
- Strategic Leadership: Ability to translate company objectives into CMC regulatory strategies, operation priorities and decisions that support program and functional goals.
- Judgment and Problem Solving: Ability to resolve ambiguous, high-impact issues by evaluating regulatory, technical, quality, patient, and business considerations.
- Executive Influence and Communication: Ability to communicate complex matters clearly, influence senior leaders and external stakeholders, negotiate effectively, and build alignment around significant decisions
- Cross-Functional Leadership: Ability to integrate differing perspectives, resolve competing priorities, and lead complex initiatives across functions without relying solely on formal authority.
- Business Acumen: Understanding of the product development lifecycle, the role of CMC within drug development, and the broader biotechnology and competitive landscape to inform decision-making and prioritization.
- Planning and Execution: Strong organizational and project management skills with the ability to manage multiple priorities, anticipate challenges, and drive critical deliverables to completion in a dynamic environment.
- Technical Proficiency: Proficient in Microsoft Office Suite, Adobe Acrobat, and other systems commonly used for regulatory documentation, submissions, and information management

**WORKING CONDITIONS**

General Office Environment. This is an indoor position that requires sitting at a desk for extended periods of time and the ability to type and use a computer. The noise level in the work environment is usually quiet to moderate.

**PHYSICAL DEMANDS**

While performing the duties of this Job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

These work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodation may be made to enable people with disabilities to perform the essential functions of the job

**EEO and Employment Eligibility:**

Aspen Neuroscience is committed to providing equal employment opportunities to all employees and job applicants and prohibits discrimination and harassment of any type. We are committed to creating an inclusive environment for all employees. Aspen is not able to provide visa sponsorship for this role. Applicants must have valid work authorization that does not require employer sponsorship now or in the future.

**Total Rewards and Culture:**

Aspen Neuroscience, Inc., located in scenic Torrey Pines, is noted for its collaborative and learning focused culture where each person is valued for contributing their strengths and energy to building a world-class line of products for patients in need. The company offers a competitive total compensation package, time-off in addition to Company observed holidays, Medical/Dental insurance benefits, onsite gym, and other wellness perks.

The anticipated salary range for candidates who will work in San Diego is $207,000 - $253,000 annually. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Aspen Neuroscience is multi-state employer, and this salary range may not reflect positions that work in other states.

California

AbbVie

Senior Counsel, U.S. Policy Legal

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

Senior Counsel, U.S. Policy Legal, will be responsible for executing comprehensive legal strategies to build and implement federal and state policy initiatives to support access for AbbVie products in the U.S. This role will focus on key external engagements for active policy shaping and external messaging strategy.

In addition, this role will participate in cross-functional engagements with related Legal, Government Affairs, Office of Ethics and Compliance (OEC), and/or business counterparts as needed to inform strategic initiatives or build cohesive AbbVie strategies.

**Key responsibilities:**

- Comply with applicable AbbVie policies and procedures.
- Develop in-depth knowledge of AbbVie’s business, company imperatives, and keep abreast of changes in laws and government policies that affect client areas.
- Provide clear advice to Government Affairs and business clients on key federal and state laws, regulations, and policies, including the Inflation Reduction Act, Medicare and Medicaid laws, the Affordable Care Act, 340B, FDA regulations, OIG guidance, and others.
- Work with legal department managers to resolve complex legal matters efficiently, and advise legal department managers of project developments in a timely manner.
- Help direct the work of outside counsel, define project objectives, manage projects.
- Work cross-functionally and find solutions for business clients consistent with the law, policies/procedures, and AbbVie’s Code of Conduct.

Qualifications

- J.D., with license to practice law in a U.S. state.
- **Minimum 5+ years (8+ years preferred) of relevant experience practicing law, preferably in a law firm, the government, a trade association, and/or in house.**
- Preferred experience practicing law focused on legislative and/or regulatory policy issues in a healthcare, pharmaceutical, or related industry.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Illinois

Senior Manager, Regulatory Affairs

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

**Position Summary**

The Senior Regulatory Affairs Manager is responsible for developing and executing regulatory strategies to support the initiation of first-in-human clinical studies for oncology products in China. This role serves as a key regulatory partner to global and local cross-functional teams, ensuring compliance with CDE requirements while supporting business objectives and patient access to innovative therapies.

The position requires strong regulatory expertise, strategic thinking, stakeholder management, excellent communication skills and leadership capabilities to successfully navigate an evolving regulatory environment and drive organizational

**Technical Competencies**

**Regulatory Strategy & Execution**

- Develop and execute regulatory strategies to achieve timely submission and approval of clinical trial applications supporting oncology first-in-human clinical trials in China, including complex global clinical trials.
- Provide regulatory guidance throughout the clinical trial application process and clinical trial execution
- Lead preparation, review, and submission of regulatory dossiers for initial CTAs and amendments in compliance with CDE requirements.
- Support accelerated approval pathways, breakthrough therapy programs, and innovative product designations where applicable.

**Regulatory Intelligence**

- Monitor and interpret changes in Chinese and global regulatory regulations, guidelines, and policies.
- Assess regulatory impact on business operations and development programs.
- Communicate emerging regulatory risks and opportunities to stakeholders.

**Health Authority Interactions**

- Lead regulatory interactions with CDE and other regulatory agencies.
- Prepare briefing packages and coordinate regulatory meetings. Serve as point of contact for global Asset Strategy Team.
- Develop effective negotiation strategies to facilitate successful regulatory outcomes.

**Quality and Compliance**

- Collaborate with Quality Assurance to maintain compliance with regulatory and quality system requirements.
- Support inspections and audits when necessary.
- Ensure regulatory documentation is maintained accurately and in accordance with company procedures.

**Soft Skills & Leadership Competencies**

**Strategic Thinking & Business Acumen**

- Ability to align regulatory strategies with business priorities and product lifecycle objectives.
- Strong understanding of the pharmaceutical industry, healthcare environment, and market access considerations.
- Ability to identify opportunities and proactively address regulatory challenges.

**Stakeholder Management & Influencing Skills**

- Demonstrated ability to influence and collaborate with stakeholders across functions and organizational levels.
- Strong partnership skills with, Clinical Development, Clinical Operations, Supply Chain, Manufacturing, Quality, and Global Regulatory teams.
- Ability to build credibility and trusted relationships internally and externally.

**Communication Skills**

- Excellent verbal and written communication skills in both English and Chinese.
- Ability to communicate complex regulatory concepts clearly to technical and non-technical audiences.
- Strong presentation, negotiation, and advocacy skills.

**Collaboration & Enterprise Mindset**

- Strong cross-cultural and cross-functional collaboration skills.
- Ability to balance local regulatory requirements with global business strategies.
- Demonstrate a patient-centric mindset and commitment to ethical business practices.

**Key Responsibilities**

**Regulatory Strategy**

1. Develop and implement regulatory strategies for assigned oncology products to achieve business objectives and ensure timely clinical trial initiation in China.
2. Provide regulatory leadership and strategic guidance throughout the lifecycle of oncology early development studies.

**Clinical Trial Application Submission and Approval**

1. Lead preparation, compilation, review, and submission of regulatory applications to CDE and other relevant authorities.
2. Coordinate cross-functional activities required to support product registrations and approvals.
3. Manage regulatory agency interactions and address questions arising during the review process.

**Regulatory Intelligence and Policy**

1. Monitor regulatory developments and assess their impact on company products and business operations.
2. Provide strategic recommendations regarding new regulations, guidelines, and industry trends.
3. Participate in industry associations and regulatory forums to influence policy discussions and maintain regulatory awareness.

**Cross-Functional Partnership**

1. Collaborate with global and local stakeholders to ensure alignment of regulatory strategies and business objectives.
2. Provide regulatory expertise to local and global project teams.

**Compliance and Quality Support**

1. Partner with Quality Assurance to maintain regulatory compliance and quality system effectiveness.
2. Support audits, inspections, and corrective actions as required.

**Reporting and Governance**

1. Provide regular updates to senior management regarding regulatory project status, risks, and mitigation plans.
2. Maintain accurate regulatory records and ensure compliance with internal governance requirements.

**Key Success Factors**

- Strong regulatory expertise and strategic mindset.
- Excellent leadership, communication and stakeholder management capabilities.
- Ability to influence decisions in a matrix organization.
- High level of integrity, accountability, and patient focus.
- Proven ability to deliver results in a complex and evolving regulatory environment.
- Commitment to continuous learning and professional development.

Qualifications

**Education**

- Bachelor's degree or above in Pharmacy, Medicine, Pharmacology, Biology, Chemistry, Life Sciences, or a related scientific discipline.
- Advanced degree (Master's, PharmD, PhD, or equivalent) preferred.

**Experience**

- Minimum 10 years of regulatory affairs experience within the pharmaceutical industry.
- Significant experience in China regulatory submissions, approvals, and lifecycle management.
- Proven experience developing and implementing regulatory strategies for innovative pharmaceutical products.
- Oncology therapeutic area experience required, with early oncology clinical development experience strongly preferred.
- Experience interacting directly with CDE, and other health authorities.
- Experience working within a multinational pharmaceutical company environment is highly desirable.
- Demonstrated experience leading complex cross-functional projects.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Other Non-US

Sanofi US

Senior Clinical Research Director

**Job title**: *Senior Clinical Research Director*

- *Location: Cambridge, MA*

Clinical Research Director (Sr CRD) is the primary clinical lead for programs.

The role requires a well-organized, strategic focused, resourceful individual with excellent emotional intelligence, self-motivation, solid analytical skills and the ability deliver to multiple operational tasks.

The role of the Senior CRD is to:

- Act as a mentor for other CRDs and Clinical Scientists on within the project/Therapeutic Area (TA).
- Collaborate with functions to ensure uniform, aligned operational approach (e.g harmonizing study documents, ES, protocols, etc). As relevant, within a project, ensure leadership, build consensus, coordinate action plans with other CRDs and stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams. He/she raises study or project-level issues to TA Heads, as relevant and shares relevant information within and beyond Project teams.

Take on as necessary the CRD role:

- Provide medical expertise to the clinical studies (except select Exploratory Pharmacology studies) and/or registries (eg: protocol, Key Results, Clinical Study Report).
- Support other clinical development activities (e.g. pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment).
- Contribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authorities.
- Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators.
- Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data.
- Interact with other CRDs in the project, Global Project Head, Pharmacovigilance, Regulatory and other key functional reps.

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

**About Sanofi**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

**Main responsibilities:**

Lead the clinical development plan strategies:

- Prepare documents and presentations for internal governance meetings.
- Responsible for the clinical development plans and clinical sections of integrated development plans (IDP).
- Collaborate with other CRDs within the project, providing leadership and building consensus.
- Coordinate action plans with stakeholders to resolve project-related study issues, anticipating potential issues (sharing lessons learned) across the project or study teams
- Raise study or project-level issues to the project head.
- Contribute to the definition of the product value proposition (TVP), TPP and market access strategy (in collaboration with respective functions) and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projects.
- Collaborate with external partners, regulators, and diverse internal stakeholders and collaborators.
- Evaluates relevant medical literature and status from competitive products.

Lead, support and oversee the execution of clinical development and studies activities:

- Review and validate the clinical study report.
- Develop the abbreviated protocol.
- Review and validate the final protocol and protocol amendments.
- Review the ICF WSI and TDF.
- Co-Develop the SAP in collaboration with bio stats.
- Responsible for key results preparation.
- Develop the clinical study report.
- Assisted by related functions (e.g. clinical operations, project management, and procurement), responsible for timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs).
- Medical support to clinical operation team during the clinical feasibility.
- Review and provide clinical input across different study documents CRF, e-diary, monitoring plan.
- Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety, stat outputs of blinded data, ) with clinical scientist, bio stat and GSO.
- Lead the study specific committees (IDMC, steering com, adjudication ) with operational support.
- Answer to medical questions raised by EC/IRBs, sites.

Responsibilities related to regulatory and safety documents and meetings:

- Represents his/her project at key regulatory agency meetings as the medical spokesperson for the studies and projects.
- Lead the strategy and structure of the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP.
- Supports registrations, label submissions and modifications.
- Review and/or contribute in the the clinical section of the Investigators brochure, CTA, IND, DSUR, INDAR, DRMP, RMP.
- Contribute to the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP.
- Ensures clinical data meets all necessary regulatory standards.
- Participates in Advisory Committee preparation.

Scientific Data evaluation and authorship:

- Participate and author manuscripts and abstracts.
- Support the planning of advisory board meetings.
- Establish and maintains appropriate collaborations with knowledge experts.
- Contribute on an ad hoc basis to specific tasks such as the evaluation of potential in-licensing candidates for I&I therapeutic area and serves as the clinical advisor to research teams.

**About You**

Minimum Level of Required Qualifications:

- Medical Doctor (MD) or equivalent
- At least 5 years experience in clinical development within the pharmaceutical industry or CRO

Preferred Qualifications:

- MD/PhD
- Specialty in Hematology
- Strong scientific and clinical acumen
- Expertise in clinical development, the methodology of clinical studies and life cycle management
- Excellent communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies.
- Demonstrated capability to challenge decision and status quo with a risk-management approach
- Ability to negotiate to ensure operational resources are available for continued clinical conduct
- Fluency in written and spoken English
- Excellent teaching skills, demonstrated ability to assist and train others
- Ability to work within a matrix model.
- International/ intercultural working skills
- Open-minded to apply new digital solutions

**Why Choose Us**

- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.
- Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
- Help improve the lives of millions of people globally by making drug development quicker and more effective.
- Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SA

\#LI-SA

\#vhd

\#LI-Hybrid

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

Massachusetts

Lundbeck

Director Regulatory Promotional Compliance & Scientific Messaging

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!

**SUMMARY**

The Director, Promotion Compliance and Scientific Messaging (US Regulatory Affairs) provides strategic regulatory leadership for advertising, promotion, scientific messaging, and external communications supporting the successful launch and lifecycle management of Lundbeck US products. The Director serves as a regulatory partner to Commercial, Medical, Legal, Market Access, Regulatory Affairs, and other cross-functional stakeholders, enabling effective and innovative product communications while ensuring compliance with FDA requirements, applicable guidance, and internal policies and procedures.

This role is expected to bring hands-on US promotional regulatory expertise across healthcare professional (HCP) and direct-to-consumer (DTC) communications and to lead complex promotional reviews and strategy from the outset. The Director leads the development and execution of regulatory advertising and promotion strategies across assigned brands and pipeline assets, providing strategic guidance on product claims, scientific messaging, payer communications, and other promotional and external communications. The Director identifies and assesses regulatory risk, establishes and communicates regulatory positions, and develops pragmatic solutions that support business objectives while maintaining regulatory compliance.

**ESSENTIAL FUNCTIONS**

- Serve as a US Regulatory Affairs advertising and promotion strategic partner for assigned brands, providing regulatory leadership across brand activities throughout launch and lifecycle management.
- Lead the regulatory review and assessment of claims, advertising and promotional materials for accuracy, consistency with approved product labeling, and compliance with FDA regulations, guidance documents, and internal policies and procedures.
- Represent and lead the Regulatory perspective in Medical, Legal and Regulatory (MLR) review and other cross-functional fora. Assess complex issues, articulate regulatory risk, negotiate positions, and develop compliant and commercially enabling solutions.
- Provide strategic regulatory guidance early in the development of scientific and promotional concepts and communication strategies, including HCP, DTC and payer communications, scientific exchange for pipeline projects, digital and social media, patient and advocacy materials, and other external communications.
- Provide regulatory promotional compliance leadership for launch planning and commercialization activities, including strategic review of launch concepts and materials that support successful execution of brand strategies.
- Provide strategic leadership for interactions with FDA/OPDP related to advertising and promotion, including advisory comments and other promotional regulatory matters, as appropriate.
- Partner closely with brand teams and with Commercial, Medical, Legal, Market Access, Corporate Communications, Regulatory Affairs, and other stakeholders to develop regulatory strategies that appropriately balance regulatory requirements, scientific evidence, patient needs, and business objectives.
- Build trusted relationships and influence effectively across organizational levels, from day-to-day brand and cross-functional teams to cross-functional stakeholders and leadership, ensuring clear and consistent communication of regulatory positions and recommendations.
- Monitor the evolving US advertising and promotion regulatory environment, including FDA regulations, guidance, enforcement activities, and industry trends, and translate developments into actionable recommendations for business and regulatory stakeholders.
- Provide regulatory leadership, coaching, and subject-matter expertise to colleagues and cross-functional stakeholders, including leadership through influence across matrixed teams.

**REQUIRED EDUCATION, EXPERIENCE AND SKILLS**

- Accredited Bachelor’s degree.
- 10+ years of R&D, regulatory or related experience within the pharmaceutical, biotechnology, and/or medical device industry, including 5+ years in the advertisement, promotional and scientific messaging area.
- Extensive, hands-on experience in US pharmaceutical advertising and promotion regulatory strategy and review of external communications for multiple audiences and channels.
- Demonstrated ability to lead complex promotional review and strategy, including interpretation and application of FDA promotional regulations and guidance and assessment of product claims and supporting scientific evidence across HCP and DTC.
- Strong knowledge of FDA requirements governing prescription drug and/or biologic advertising and promotion and experience navigating FDA interactions, including OPDP communications.
- Demonstrated ability to assess complex or novel regulatory issues, establish and clearly communicate regulatory positions, identify and articulate risk-based decisions, and develop pragmatic solutions that appropriately support compliance and business objectives.
- Strong understanding of scientific data and demonstrated ability to critically evaluate scientific evidence supporting promotional claims and communications.
- Demonstrated strategic leadership and ability to influence effectively at multiple levels, including brand and cross-functional teams as well as senior cross-functional stakeholders and leadership, in a highly matrixed environment.
- Experience supporting product launches and lifecycle management activities from an advertising and promotion regulatory perspective.
- Excellent negotiation, interpersonal, written, and oral communication skills.
- Demonstrated ability to manage multiple priorities, exercise sound independent judgment, and deliver high-quality work within established timelines.
- Ability to work independently while collaborating effectively within multidisciplinary, matrixed, and potentially global teams.

**PREFERRED EDUCATION, EXPERIENCE AND SKILLS:**

- Accredited Bachelor’s degree in life sciences or advanced degree in a scientific or healthcare-related field (PhD, PharmD, Master’s degree) and/or MBA.
- Experience supporting biologic and small-molecule products, including orphan and neuro-rare products.
- Experience leading FDA/OPDP interactions and promotional advisory comment processes.
- Experience leading cross-functional process improvement and development of advertising and promotion compliance capabilities.
- Experience providing leadership, coaching, or development to Regulatory Affairs colleagues and/or direct reports.
- Experience leveraging AI-enabled tools, modular content approaches, and other emerging digital capabilities to support compliant content development, review, governance, and lifecycle management in a regulated environment.
- Strong Preference to be based in Boston, MA area

**TRAVEL**

- Ability and willingness to travel domestically and internationally up to approximately 20%, as business needs require.
- If based remotely, additional travel will be required to Boston, MA to meet the needs of the role and the business

The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate’s geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $200,000 - $225,000 and eligibility for a 25% bonus target based on company and individual performance, and eligibility to participate in the company’s long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our [site.](<https://www.lundbeck.com/content/dam/lundbeck-com/americas/united-states/careers/Lundbeck_Benefits_Summary.pdf>) Applications accepted on an ongoing basis. #LI-LM1, #LI-Remote

**Why Lundbeck**

Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the [U.S. career site](<https://www.lundbeck.com/content/dam/lundbeck-com/americas/united-states/careers/Lundbeck_Benefits_Summary.pdf>).

*Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the* [*U.S. career site*](<https://www.lundbeck.com/us/careers/your-job/eeo-accommodations-policy>).

*Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in* [*E-Verify*](<https://www.lundbeck.com/content/dam/lundbeck-com/americas/united-states/careers/E-Verify_Participation_Poster_Eng_Es.pdf>).

Senior Manager Regulatory Promotional Compliance & Scientific Messaging

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!

**SUMMARY:**

The Senior Manager, Promotion Compliance and Scientific Messaging (US Regulatory Affairs) provides regulatory advertising and promotional support for the successful launch and lifecycle management of Lundbeck US products. The role serves as a regulatory partner to Commercial, Medical, Legal, and other cross-functional stakeholders, helping enable effective product communications while ensuring compliance with FDA requirements, applicable guidance, and internal policies and procedures.

The Senior Manager will have a primary focus on direct-to-consumer (DTC) communications, including consumer campaigns, digital and social media, patient and advocacy materials, and related scientific messaging. The role manages assigned promotional review activities within this remit, providing regulatory guidance on DTC concepts and claims, identifying and communicating regulatory risk, and developing practical solutions in partnership with cross-functional teams, and escalating novel, highly complex, and precedent-setting matters as appropriate.

The Senior Manager will also support HCP communications and scientific exchange activities, contributing across the broader promotional compliance portfolio when needed. In addition, the Senior Manager will contribute to regulatory launch and lifecycle activities, FDA promotional submissions, regulatory intelligence, and continuous improvement of advertising and promotion review processes, escalating novel, highly complex, and precedent-setting matters as appropriate.

**ESSENTIAL FUNCTIONS:**

- Serve as a US Regulatory Affairs advertising and promotion partner for assigned brands and activities, with primary responsibility for DTC print, digital and social media communications and other consumer-facing channels.
- Review and assess assigned advertising and promotional materials for accuracy, consistency with approved product labeling, and compliance with FDA regulations, guidance documents, and internal policies and procedures.
- Represent the Regulatory perspective in Medical, Legal and Regulatory (MLR) review and other cross-functional forums for assigned materials. Identify and communicate regulatory risks, negotiate positions, and propose practical, compliant solutions, escalating where appropriate.
- Provide regulatory guidance early in the development of DTC concepts and communication strategies, including television and other consumer campaigns, digital and social media, patient and advocacy materials, and related scientific messaging.
- Support HCP promotional communications and scientific exchange activities as part of the broader Promotion Compliance and Scientific Messaging portfolio.
- Support launch planning and lifecycle management activities, including review of launch concepts and materials, timeline coordination, and communication of regulatory considerations to cross-functional partners.
- Monitor the evolving US advertising and promotion regulatory environment, including FDA regulations, guidance, enforcement activities, and relevant industry trends, and communicate potential implications to internal stakeholders.
- Contribute to continuous improvement of advertising and promotional review processes through cross-functional collaboration, supporting compliance, efficiency, decision-making, and quality.
- Contribute subject-matter expertise and share best practices with Regulatory Affairs colleagues and cross-functional partners.

**REQUIRED EDUCATION, EXPERIENCE AND SKILLS:**

- Accredited bachelor’s degree.
- 5+ years of experience in Regulatory Affairs, R&D, or a related area within the pharmaceutical or biotechnology industry, including 2 years of direct advertising and promotion experience or closely applicable Regulatory expertise.
- Working knowledge of US FDA advertising and promotion requirements, with demonstrated experience reviewing and interpreting customer communications.
- Hands-on experience with DTC promotional review and demonstrated ability to assess consumer-facing claims, presentations, and supporting scientific evidence.
- Demonstrated understanding of scientific data and promotional regulations as they relate to drugs and/or biologics.
- Experience identifying and communicating regulatory risk and effectively working cross-functionally in multidisciplinary and matrixed teams to negotiate and resolve differences.
- Ability to independently manage assigned work, exercise sound judgment within established regulatory frameworks, and recognize when escalation is appropriate.
- Strong attention to detail and organizational skills, with the ability to manage multiple competing priorities and consistently meet deadlines.
- Excellent oral and written communication skills, including the ability to articulate regulatory positions clearly and constructively.

**PREFERRED EDUCATION, EXPERIENCE AND SKILLS:**

- Accredited bachelor’s degree in life sciences, pharmacy, chemistry, or a related field or Advanced degree in a scientific or healthcare-related field (PhD, PharmD, Master’s degree).
- Experience developing, reviewing, or launching DTC campaign materials, including television commercials, digital and social media, and/or patient and advocacy materials.
- Experience with social media and emerging consumer communication channels, social influencers or media pitching in the pharmaceutical environment.
- Experience reviewing HCP promotional communications and/or scientific exchange materials.
- Experience supporting both biologic and small-molecule products, including orphan and neuro-rare products.
- Experience with promotional review and regulatory content-management platforms, including Veeva PromoMats and/or related Veeva platforms.
- Strong Preference to be based in Boston, MA

**TRAVEL:**

- Ability to travel up to 20% international travel may be required.
- If based remotely, additional travel will be required to Boston, MA, to meet the needs of the role and the business

The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate’s geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $140,000 - $165,000 and eligibility for a 15% bonus target based on company and individual performance, and eligibility to participate in the company’s long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our site. Applications accepted on an ongoing basis. #LI-LM1, #LI-Remote

**Why Lundbeck**

Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the [U.S. career site](<https://www.lundbeck.com/content/dam/lundbeck-com/americas/united-states/careers/Lundbeck_Benefits_Summary.pdf>).

*Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the* [*U.S. career site*](<https://www.lundbeck.com/us/careers/your-job/eeo-accommodations-policy>).

*Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in* [*E-Verify*](<https://www.lundbeck.com/content/dam/lundbeck-com/americas/united-states/careers/E-Verify_Participation_Poster_Eng_Es.pdf>).

Frederick National Laboratory for Cancer Research

Research Associate I - ADRD

**Research Associate I - ADRD**

Job ID: req4723

Employee Type: exempt full-time

Division: Applied & Development Research Program

Facility: Frederick: Ft Detrick

Location: PO Box B, Frederick, MD 21702 USA

The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

**Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.**

**PROGRAM DESCRIPTION**

The In Vivo Evaluation Group, Biological Testing Branch (BTB) of the Developmental Therapeutics Program (DTP), Division of Cancer Treatment and Diagnosis (DCTD) is establishing both in vitro and in vivo tumor lines from patient biopsies from DCTD sponsored clinical trials with the goal of developing models for NCI’s Patient Derived Models Repository (PDMR). The PDMR is a repository of patient-derived models that include in vivo tumor fragments, in vitro tumor lines (2D and 3D), cancer associated fibroblasts, and DNA/RNA isolates. The goal of the PDMR is to distribute well validated and highly characterized material to researchers worldwide. A secondary mission is to evaluate the efficacy of approved oncology drugs in combination or as single agents in a subset of rare and recalcitrant PDX tumor models. In addition to the above, the candidate may also be responsible for establishing, characterizing and propagating murine tumor models. As each model is developed and fully characterized, preclinical studies are performed to evaluate the efficacy of immuno-oncology agents, small molecule targeted therapies alone or in combination and other agents of interest to the program.

**KEY ROLES/RESPONSIBILITIES**

- Implant biopsied tumor material derived from patients into mice/rats, monitor the mice/rats daily for tumor growth, measure tumors, harvest tumor tissue for the repository and provide tumor material to staff for the establishment of in vitro cultures, quality control, RNA and DNA preparation for sequencing
- Update the patient-derived xenograft (PDX) tracking sheets and log experimental data into Studylog. The maintenance of proper records is critical as each patient sample will be passaged and expanded multiple times in NSG mice or in rats
- Implant, establish and propagate murine tumor models
- Perform drug toxicity and drug efficacy studies that require administration of test agents by multiple routes (IV, IP, PO, SC) on schedules varying from a single dose to multiple times per day for multiple days/weeks depending on the agents administered
- Maintain a proper living environment for test animals
- Aid in any other routine tasks as needed (tube labeling, sample deliveries/pick-ups, autoclaving instruments, etc.).
- Occasional weekend work is required
- Tasks are performed independently and initially will involve training and supervision

**BASIC QUALIFICATIONS**

**To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:**

- Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
- In addition to the education requirement, a minimum of two (2) years of related experience
- Proficiency with Microsoft Windows and Microsoft Office
- Demonstrated organizational skills and database management skills
- Ability to maintain precise records
- Ability to be flexible to meet changing needs
- Ability to work in a fast-paced environment
- Ability to work alone as well as part of a team
- Good written and verbal communication skills
- Ability to obtain and maintain a security clearance

**PREFERRED QUALIFICATIONS**

**Candidates with these desired skills will be given preferential consideration:**

- Previous animal handling experience
- Knowledge of basic necropsy techniques
- Experience with IV, IP, PO, SC injections
- Previous experience working under ABSL-2 conditions

**JOB HAZARDS**

- This position is subject to working with or has the potential for exposure to animals(s) and/or animal material(s).
- This position is subject to working with or has the potential for exposure to infectious material, requiring medical clearance and immunizations.

**Commitment to Non-Discrimination**

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

**Pay and Benefits**

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available [here](<https://frederick.cancer.gov/careers/benefits>)

59,600.00 - 85,400.00 USD

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions

Maryland

Otsuka America Pharmaceutical, Inc.

Director, Clinical Management- early phase, immunology/autoimmune

**Job Summary**

In collaboration with the Senior Director of Clinical Management, the Director is responsible for the operational strategy and management of Otsuka clinical programs, including coordination with other relevant parties (e.g., other Otsuka departments, external service providers (ESPs), etc.). Responsibilities include the planning, execution, and completion of clinical programs according to applicable regulations and guidance; ICH Guidelines, Good Clinical Practices (GCP), and Otsuka SOPs, within agreed upon timelines and budget.

**Job Description**

• Provides scientific clinical research and operational expertise in the development of overall strategy and objectives of the Global Clinical Development Plan (GCDP), including performing/overseeing and providing background research.

• May represent Clinical Management in the development of the Clinical Development Plan, timelines, and budget for Business Development opportunities.

• Ensures program specific standards (e.g., CRFs, outsourcing specifications, slides, training, templates) are developed and applied across all studies to ensure consistency of clinical dossier.

• Contributes to final analysis and interpretation including the development of clinical trial reports, publications, and internal/external presentations.

• Develops program level financial estimates and contributes to the MLTP. • Leads program level teams as Co-Chair and/or serves as lead clinical management representative for various meetings including, CRT/GBT/PDC/JDC/Alliance.

• Contributes to the preparation and defense of clinical program documents (investigator brochure (IB)/IMPD, IND/CTA annual reports, Health Authority briefing books and submissions (NDA, MA, NDS etc.), including ongoing maintenance of filings and support of labeling teams.

• Leads development of clinical sections of regulatory documents (i.e., Investigators’ Brochures, briefing books, submission dossier, and responses to Health Authorities questions) and inspection readiness programs, where appropriate.

• Develops strong scientific partnership with key advisors in assigned therapy area to optimize scientific quality/innovation of clinical study design, execution, reporting and publication. Leads program-related advisory boards/committees and meetings.

• Supports the design & implementation of a program level HEOR strategy, including endpoint development where necessary.

• Serves as contact for Medical Affairs/PBS related to medical information requests, public disclosure of information (e.g., [clinicaltrials.gov](<http://clinicaltrials.gov>)) and publications strategies. • Represents assigned programs to senior management and OPCJ and disseminates information and tasks to team members.

• Participates in External Service Provider (ESP) partnership governance and alliance management activities as assigned.  
• Assists Senior Director with portfolio level resource planning.

• Gives direction, training, and support to Clinical Management personnel within program/compound team.

• Participates in ongoing review of clinical trial data focusing on data integrity, trending, and consistency.

• Ensures inspection readiness activities are planned and conducted appropriately across program.

• Participate in program-level risk mitigation activities.

• Represent Clinical Management in departmental and cross-functional initiatives, as assigned.

• Leads and/or contributes to assigned departmental, ESP and corporate standardization and continuous improvement efforts.

• May have supervisory responsibilities including:

• Coordinating the training and onboarding of new employee(s) on corporate culture, corporate goals/vision and departmental policies and processes.

• Assuring compliance with departmental, SOP, compliance, and corporate training

• Ensuring assigned staff have access to all required materials, systems, and training to complete job responsibilities.

• Setting clear performance expectations and individual development plans and providing specific and frequent feedback to the employee on his/her performance.

• Performs other duties, as assigned.

**Qualifications/ Required**

Knowledge/ Experience and Skills:

• Comprehensive knowledge of clinical operations, drug development process, standard operating procedures (SOPs) and GCP/ICH regulations.

• Thorough knowledge of contract research organizations (CROs), outsourcing, and evaluation of work performed against vendor Statement of Work (SOW).

• Advanced understanding of drug development principles and clinical trial implementation and management.

• Strong knowledge of global regulatory requirements and compliance, biostatistics, data management, and medical writing.

• Strong communication, organization, planning, analytical, problem solving, and people management skills.

• Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). Good understanding of clinical trial related software (e.g., eCRFs, IRT, CTMS, etc.).

• Ability to travel up to 25%.

Educational Qualification Required:

• Bachelor’s Degree with a minimum of 14 years of applicable pharmaceutical industry experience including 10 years clinical trial management experience. Previous supervisory experience.

Preferred Qualifications:

• Advanced Degree

**Competencies**  
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.  
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.  
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.  
**Impactful Communication -**  Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.  
**Respectful Collaboration -** Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.  
**Empowered Development -** Play an active role in professional development as a business imperative.

Minimum $186,489.00 - Maximum $278,875.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Nationwide

Eli Lilly and Company

Sr. Director- GQA Global Medical Regulatory Safety

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Sr. Director- GQA Global Medical Regulatory Safety

**Responsibilities**

This role leads the Global Quality Auditing (GQA) teams responsible for executing audits of operating units in Clinical Development (GCP), ATPLV: ADME (Absorption, Distribution, Metabolism, and Excretion), Toxicology, PK/PD (Pharmacokinetics/Pharmacodynamics), LEM (Laboratory for Experimental Medicine), Veterinary Resources (GLP), Global Patient Safety/Pharmacovigilance (GVP), Regulatory Affairs and Product Quality, including conducting GxP audits of operations in Lilly’s affiliates. These audits serve to ensure that research conducted and sponsored by the Company, as well as product and disease state information shared with customers are in accordance with Company policies, practices and procedures and in compliance with current regulations and guidelines.

The broad scope of auditing managed by the Sr. Director requires that the Sr. Director provides strategic input to the overall GQA audit program and interacts effectively with global quality leadership and business unit stakeholders. The Sr. Director is responsible for staying abreast of the changing environment, both internal business priorities and external regulatory expectations, to identify and focus continuous improvement efforts.

**Key Objectives/Deliverables:**

**Compliance**

- Understand the strategic and operating needs of the primary business areas to ensure that resources and quality improvements are focused on high-risk business activities. Lead the definition of the quality strategy and GQA audit plans for the areas of responsibility. Apply risk management principles to make certain the audit plans adequately cover the key risks of Lilly processes, procedures, and facilities, investigational sites, laboratories and contract research organizations, as well as other third-party collaborations.
- Assess whether data reported in support of registration for pharmaceutical products were generated according to applicable international / national regulations and the required corporate policies and procedures. Communicate any potential gaps to senior management in a timely manner.
- Based on review of audit findings or trends, highlight key areas for improvement within Clinical Development, Regulatory, Safety/Pharmacovigilance and Product Quality, with appropriate escalation of issues.
- Verify that work performed by vendors complies with Lilly and external regulatory quality requirements.
- Through engagement with pharmaceutical company peers and agency staff, seek to understand the changing regulatory environment, and proactively adapt work and company policies and procedures to align with regulatory expectations.

**Business**

- Manage and provide leadership to a global staff of quality auditors in support of the implementation of the GQA audit program, objectives, and business operations.
- Participate in component-wide QA strategic planning meetings. Define strategy and action plans to continue to strengthen our GQA organization supporting Lilly’s corporate goals and objectives.
- Understand and extensively network with the LRL functional business area management to evaluate the impact of the quality strategy and seek synergies in our operations.
- Participate actively as a member of the GQA lead team in making and supporting key decisions and providing input to the strategic direction for the component.
- Participate in business planning process for GQA. Manage budget and headcount to meet targets.

**People**

- Continuously assess business needs and allocate people and finances in a manner that efficiently utilizes and grows talent/expertise and balances audit demands versus GQA capacity.
- Ensure that sufficient technical resources are available, and the optimal organization exists, through a combination of education, experience and training to execute the audit plans and provide adequate support to the relevant business areas, quality and GQA.
- Partner with each Associate Director/Director, Sr. Director and other direct reports to ensure that challenging departmental and individual objectives are established and that all employees are following the global performance management processes.
- Partner with each manager and other direct reports to verify that all team members have a robust development and career plan. Provide timely feedback and coaching to aid in their development.
- Maintain appropriate knowledge and experience of quality assurance and technical expertise to facilitate necessary strategy development and decision-making.

**Basic Qualifications**

- Education: Bachelor’s Degree or equivalent in a scientific or health-related field.
- Experience: Minimum of five (5) years relevant industry experience in quality, clinical development, safety or regulatory affairs.
- Prior line management experience.

**Additional Skills/ Preferences**

- Advanced degree (Masters, Doctorate) in a scientific or health-related field.
- Experience in multiple facets of drug development, particularly clinical research, pharmacovigilance, regulatory affairs and product development.
- Experience in Quality Assurance or Auditing.
- A deep understanding of quality systems and business process management.
- Demonstrated ability to collaborate across boundaries and achieve results with internal and external partners.
- Experience leading change.
- Demonstrated ability to recruit and develop top talent.
- Ability to interpret and apply regulations, regulatory guidance, codes and public expectations and identify and recommend compliance changes as appropriate.
- Proven ability to synthesize information from multiple sources and make risk-based decisions.
- Excellent interpersonal skills, with proven ability to remain constructive and influential with peers, management and senior leadership, even in difficult situations.
- Ability to deliver timely and professional communications (oral and written) with precision and clarity to all levels of the organization.
- Work independently as well as collaboratively within a global team environment.
- Good analytical/problem-solving skills.

**Additional Information**

- Located at Lilly Corporate Center.
- Occasional domestic and international travel, sometimes on short notice.
- Travel Percentage 0-10%

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$163,500 - $239,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Indiana

Senior Director, European Regulatory Strategy Lead

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Organization and Position Overview**

**Centessa Pharmaceuticals**, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing **orexin receptor 2 (OX2R) agonists** **as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders**. Centessa’s lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions. Headquartered in Boston, Massachusetts, Centessa was recognized as a Great Place to Work® in 2026.

As the **Senior Director, European Regulatory Strategy**, you will report to the SVP, Regulatory and Medical Writing and serve as a key member of our regulatory team, providing strategic and operational regulatory leadership across development programs with a primary focus on Europe. As the Regulatory Lead for assigned assets, you will develop and execute regulatory strategies spanning nonclinical, clinical, and registration activities, with a particular focus on the European Union, United Kingdom, and Switzerland. The role requires extensive experience leading European regulatory programs and managing interactions with health authorities, including the EMA, EU National Competent Authorities, MHRA, Swissmedic, and other applicable regulatory agencies.

In partnership with cross-functional development teams, you will provide regulatory guidance, lead regulatory sub-teams, and align stakeholders to support successful program advancement from development through registration and lifecycle management. The role requires demonstrated experience with pediatric development and regulatory submissions, including pediatric regulatory strategy and health authority interactions. Experience with regulatory programs in APAC, particularly Japan and China, is a plus. If you enjoy fast-pace environment, have had success operating within a matrixed organization and leveraging external regulatory consultants and vendors while driving regulatory excellence across the portfolio, you will thrive in this opportunity.

**Responsibilities**

- Serve as the European Regulatory Lead for our lead program cleminorexton and other assigned development programs, providing strategic regulatory leadership from early development through registration and lifecycle management.
- Develop and execute regulatory strategies to obtain, maintain, and expand product registrations across the European Union, United Kingdom, Switzerland, and other applicable regions.
- Lead the planning, preparation, and submission of major regulatory filings, including Marketing Authorisation Applications (MAAs), Clinical Trial Applications (CTAs), pediatric regulatory submissions, briefing documents, and other regulatory submissions within scope of responsibility.
- Represent the company in regulatory interactions and lead meetings with European health authorities, including the EMA, EU National Competent Authorities, MHRA, and Swissmedic.
- Provide EU regulatory guidance and strategic input to cross-functional program teams, ensuring regulatory considerations are integrated into development plans and key business decisions.
- Provide strategic regulatory leadership for ex-US pediatric development and submission activities, including pediatric regulatory strategy, submission planning, and interactions with relevant health authorities.
- Ensure ongoing compliance with applicable European and international regulatory requirements and guidance, communicating regulatory developments and implications to relevant stakeholders.
- Partner with the SVP, Regulatory and Medical Writing and broader Regulatory Affairs leadership to strengthen departmental capabilities, operational excellence, and efficient execution across the portfolio.
- Identify, engage, and oversee external EU regulatory consultants and vendors to support the successful execution of regulatory strategies and submissions.
- Collaborate with global regulatory colleagues to ensure alignment between European regulatory strategies and development or registration activities in other regions, as appropriate.

**Basic Requirements**

- Bachelor's degree in a scientific discipline with 12+ years of progressive regulatory affairs experience within the pharmaceutical or biotechnology industry, including 5+ years in a regulatory leadership role with significant European experience.
- Advanced degree (PhD, PharmD, MS, or JD) and experience supporting small molecule development strongly preferred.
- Significant experience leading European regulatory strategies and submissions, including substantial experience with regulatory requirements and health authority interactions in the EU, UK, and/or Switzerland.
- Significant experience with EU pediatric regulatory strategy and submissions, including direct involvement in pediatric development, submission preparation, and health authority interactions.
- Must have recent significant experience with EU regulatory submission strategy, structure, and content, including MAAs, CTAs, pediatric submissions, briefing documents, and other European regulatory filings.
- Demonstrated track record of successful regulatory interactions with the EMA, EU National Competent Authorities, MHRA, Swissmedic, and other applicable health authorities supporting major submissions and product approvals.
- Proven success serving as the European Regulatory Lead for development and registration-stage programs within a matrixed environment.
- Extensive knowledge of nonclinical and clinical drug development, ICH, EMA, EU regulatory requirements, EU National Competent Authorities, MHRA, Swissmedic, and other applicable international regulatory requirements and guidelines.
- Strong experience leading cross-functional teams and providing strategic regulatory guidance to development programs from early development through registration and lifecycle management.
- Excellent written, verbal, presentation, and influencing skills, with the ability to communicate complex regulatory strategies and risks to senior management, health authorities, consultants, and external partners.
- Proven analytical, problem-solving, organizational, negotiation, and decision-making skills, with the ability to develop regulatory strategies and compelling, data-driven regulatory narratives.
- Demonstrated ability to thrive in a fast-paced, innovative environment while fostering collaboration, open communication, and alignment among diverse stakeholders.

**Additional Preferences**

- CNS experience highly preferred.
- Experience with regulatory submissions and health authority interactions in Japan and/or China is a plus.
- Experience interfacing with a US-based Global Regulatory team and cross-functional partners.

- Intrinsically curious and deeply passionate about the work we do.

**Work Location**

The Senior Director, Global Regulatory Strategy role is based in the UK with occasional travel including to the US.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$160,500 - $259,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Amgen

Senior Manager, US Primary Market Research

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Senior Manager, US Primary Market Research**

**What you will do**

Lets do this. Lets change the world. In this vital role you will be a strategic thought partner to brand and crossfunctional teams, responsible for generating rigorous, businessrelevant insights that inform brand strategy, execution, and decisionmaking.

In an environment enabled by data integration via Amgens MRAgent platform, this role focuses less on managing research outputs and more on owning insight judgment, meaning, and impactensuring data is interpreted correctly, synthesized effectively, and translated into clear strategic guidance.

**Flexible Commuter role to Thousand Oaks, CA office. You will work on-site 2-3 days a week.**

**Strategic Thought Partnership**

- Serve as the primary PMR (Primary Market Research) thought partner to the Commercial team (primarily brand teams), guiding the framing of business questions and translating insights into implications for brand strategy and execution.
- Act as an internal consultant, helping stakeholders move from data to decisions by identifying the so what and now what.
- Support key annual activities (e.g., brand planning, executive reviews, budgeting, business cases) with objective, insightdriven guidance.

**Insight Generation & Interpretation**

- Lead the interpretation and synthesis of primary market research findings, leveraging standardized dashboards, analytics tools, and AIenabled capabilities (e.g., MRAgent).
- Go beyond descriptive findings to surface insights, risks, opportunities, and strategic tradeoffs.
- Integrate learnings across studies, time periods, and data sources to provide a coherent view of brand and portfolio performance.

**Data & Business Rule Ownership**

- Own KPI definitions, business rules, and analytic intent for assigned brands and studies, ensuring clarity, consistency, and longitudinal integrity.
- Ensure that changes to questionnaires, metrics, or data cuts are intentional, documented, and aligned with relevant partners.
- Maintain high standards for data quality, methodological rigor, and trend continuity.

**Team Leadership & Development**

- Partner with other PMR and CD&A team members, developing strategic thinking, analytical judgment, and stakeholder confidence.
- Coach other PMR team members when needed, to help shape their skills and to provide business context to ensure more rounded analyses.
- Guide teams on how to effectively leverage modern tools and analytics while maintaining strong research fundamentals.
- Work with their Director to prioritize and balance business asks, to ensure focus on the highestvalue insight opportunities.

**Stakeholder Enablement & Change Leadership**

- Manage expectations with stakeholders regarding selfservice insights vs. valueadd PMR partnership.
- Facilitate strategic discussions rather than presenting findings, especially in environments where stakeholders have direct data access.
- Support adoption and effective use of new research tools and ways of working.

**Capability & Process Advancement**

- Contribute to the continuous evolution of PMR (Market Research) capabilities, methodologies, and tools.
- Identify opportunities to improve efficiency, consistency, and impact of primary market research across brands.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a collaborator with these qualifications.

**Basic Qualifications:**

Doctorate degree and 2 years of experience in analytics, sales, marketing, or related functions

OR

Masters degree and 4 years of experience in analytics, sales, marketing, or related functions

OR

Bachelors degree and 6 years of experience in analytics, sales, marketing, or related functions

OR

Associates degree and 10 years of experience in analytics, sales, marketing, or related functions

OR

High school diploma / GED and 12 years of experience in analytics, sales, marketing, or related functions

**Preferred Qualifications:**

- Experience in pharmaceutical or life sciences industry
- Deep expertise in primary market research methodologies (qualitative and quantitative)
- Strong analytical skills with the ability to translate complex data into actionable insights
- Demonstrated ability to think strategically and influence decisionmaking
- Excellent written, verbal, and facilitation skills with senior audiences
- Proven ability to work collaboratively across functions in a matrixed environment
- Experience coaching and developing talent

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Senior Research Statistician - Statistical Innovation (Hybrid)

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

The **Senior Research Statistician** in Statistical Innovation is responsible for providing scientific and statistical leadership to support initiatives on designing innovative clinical trials and to evaluate, develop and deploy advanced and novel statistical/analytical modeling and simulations to drive statistical innovation modeling and simulation in Clinical Development.

**Responsibilities:**

- Actively supports in the evaluation, introduction, development and education of novel statistical and/or machine learning/deep learning approaches.
- Demonstrates extensive competence in investigating/evaluating complex innovative designs and analysis options using scientific computing, modeling and simulations.
- Demonstrates extended understanding and actively seeks to acquire new knowledge in advanced and emerging statistical methods (e.g. Adaptive designs, Bayesian methods, synthetic control, predictive modeling etc.).
- Applies imagination. Creates, invents, and implements new or better approaches, alternatives, and breakthrough ideas in modeling and simulations.
- Demonstrates ability to apply statistical knowledge to solve real-world problems. Demonstrates the ability to evaluate alternative statistical and machine learning approaches.
- Shows proficiency in development, implementation, and rollout of statistical and deep learning tools and techniques (e.g. using R, R-shiny, Python, Julia, etc.) to operationalize key innovative methodologies.
- Builds and maintains external reputation and influences industry with presentations, attending industry meetings, or authoring articles for peer-reviewed publications.

Qualifications

**Minimum Qualifications**

- PhD in Statistics, Biostatistics or a highly related field.
- Advanced knowledge of statistical modeling and methodology and good understanding of drug development process.
- Demonstrated experience in advanced statistical computing & simulation skills.
- Proven expertise in standard (e.g. SAS, R)

**Preferred Qualifications:**

- Experience in pharmaceutical development and applied statistics/statistical consulting preferred.
- Expertise in specialized statistical software (e.g., FACTS, EAST, etc.) is preferred.

**Other Required Skills:**

- Proven ability to collaborate and consult with discipline experts and leaders within and across function.
- Excellent communication skills, both oral and written
- Excellent teamwork and leadership skills
- Passionate about statistical innovation and always think out of the box and is never satisfied with status quo

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Principal Research Scientist I - Biologics Drug Product Development

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

The Drug Product Development (DPD) group within AbbVie is a global organization responsible for developing and characterizing drug product formulations and manufacturing processes for biologic therapeutics (antibodies, antibody-drug conjugates (ADCs), and novel biologic formats) from preclinical development through clinical proof of concept.

We have an exciting opportunity for a Principle Scientist I to join our team at our AbbVie Bay Area (ABA) site in South San Francisco, CA. This is an on-site role and will serve as our outsourcing lead for formulation and process development. This individual will be the primary technical interface between AbbVie and external Contract Development and Manufacturing Organizations (CDMOs), ensuring successful execution of outsourced drug product development. The role is responsible for driving external execution while partnering closely with drug product leads, operations specialists, and functional management to ensure alignment of strategy, timelines, risks, and deliverables and will be expected to take a first look at work packages, data and conclusions from CDMOs. The individual will serve as a technical representative of ABA DPD, providing leadership across internal and external teams to advance programs efficiently and compliantly.

**Responsibilities**

- Serve as the primary technical liaison between ABA DPD and CDMOs and ensure functional alignment with management and relevant stakeholders for all external drug product development activities.
- Lead external drug product development activities, including formulation development, process development, technology transfer, manufacturing support, and data package generation in line with the overarching drug product development strategy owner by the drug product lead.
- Oversee CDMO execution of studies, development plans, data packages and technical deliverables to ensure alignment with program objectives and functional strategies.
- Review and provide scientific input on study designs, protocols, reports, development recommendations, and investigations to the internal team, receive alignment and effectively communicate to the CDMO.
- Ensure AbbVie readiness for CDMO governance and technical meetings through proactive alignment, issue resolution, and decision preparation.
- Coordinate communication and information flow between CDMOs and internal stakeholders.
- Drive action-item tracking, meeting documentation, risk management, and issue escalation. Ensures organization across documents, meeting minutes, etc.
- Ensures functional alignment on Statements of Work (SOWs), and partners with operations lead on contract signing and execution, shipping logistics, and operational activities.
- Provide technical leadership in the investigation and resolution of issues occurring at external sites in alignment with functional and project strategy.
- Maintain organized project documentation and knowledge management systems within approved AbbVie platforms.
- May support internal programs as drug product lead on CMC cross-functional teams.

**Leadership Expectations**

- Influence decisions and drive execution across a complex matrix organization without direct authority.
- Build strong partnerships with internal stakeholders and external vendors.
- Anticipate risks and proactively develop mitigation strategies.
- Communicate complex technical information clearly to diverse audiences.
- Represent ABA DPD as a trusted technical leader to CDMOs and cross-functional partners.
- Mentor junior scientists and contribute external development strategies within the function.

Qualifications

- BS or equivalent education and extensive, typically 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of industry experience is required (in chemical engineering, pharmaceutical sciences, material science, analytical sciences, or equivalent field, is highly preferred).
- Strong technical background in formulation principles, drug product degradation pathways, drug product lyophilization and processing, and deep understanding of characterization approaches, DOE using JMP/Design Expert.
- 3-5 years leading external development activities at CDMO including but not limited to oversight, method and tech transfer; demonstrated success in resolving investigations with external partners.
- Hands-on experience in analytical techniques used for protein characterization and stability testing preferred (e.g., SEC, CE-SDS, icIEF, HIAC, MFI, DLS, etc.).
- Strong project leadership, stakeholder management, and organizational skills.
- Excellent communication (oral and written), negotiation, and influence skills.
- Demonstrated experience leading cross functional teams without direct authority.
- Ability to manage multiple priorities, drive alignment, and resolve complex technical and operational challenges.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Local Trial Manager

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Local Trial Manager**

Duties: Process clinical data, including receipt, entry, verification, or filing of information; Monitor work productivity or quality to ensure compliance with standard operating procedures; Contribute to the compilation, organization, and production of protocols, clinical study reports, regulatory submissions, or other controlled documentation; Read technical literature and participate in continuing education or professional associations to maintain awareness of current database technology and best practices; Provide support and information to functional areas such as marketing, clinical monitoring, and medical affairs; Partner with global and local country teams to provide high level country strategy and actively drive study progress and local/country level study delivery; Plan, manage and oversee the clinical study implementation in accordance with the global program strategy, through leadership with engagement of the cross-functional Local Study Team; Communication country status (including timelines and results) to key partners including updated to relevant systems for transparency; Provide country level input into the Country Operational Plan and partners with the Development Feasibility Manager through feasibility and with the Global Clinical Managers to ensure local delivery of the study; Support internal audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate; and Assign and deliver all study support staff and continually review country level risk mitigation to ensure study delivers to plan. May telecommute.

Requirements: Masters degree (or foreign equivalent) in Drug Regulatory Affairs, Biology, Chemistry or related field & 3 years of experience in the job offered or in clinical trial-related occupation. The position requires 3 years of experience in the following:

1. Applying ICH E6 (R2) Good Clinical Practice (GCP) and related ICH guidelines in the management of global clinical trials;

2. Interpreting and implementing FDA regulations (21 CFR Parts 11, 50, 54, 56, and 312) and other applicable regulatory requirements in clinical trial execution;

3. Managing clinical trial activities from study start-up through close-out in accordance with regulatory and protocol requirements;

4. Developing and monitoring Country Operational Plans (COPs), study timelines, milestone tracking, and enrollment forecasting;

5. Managing and oversee external vendors, including Clinical Research Organizations (CROs), central laboratories, imaging vendors, and IRT providers;

6. Utilizing Electronic Data Capture (EDC) systems including Medidata Rave for clinical data oversight and monitoring;

7. Utilizing Electronic Trial Master File (eTMF) systems including Veeva Vault TMF to ensure documentation completeness and inspection readiness;

8. Utilizing Clinical Trial Management Systems (CTMS) to track study progress, budgets, and performance metrics;

9. Overseeing Interactive Response Technology (IRT/IWRS/IVRS) systems for enrollment tracking and investigational product management;

10. Monitoring and analyzing time, cost, and quality performance metrics, including Key Performance Indicators (KPIs);

11. Identifying, assessing, and mitigating regulatory and operational risks using risk-based quality management (RBQM) principles;

12. Supporting and coordinating regulatory submissions, including ethics committee, IRB applications, health authority communications, and Supporting clinical-to-commercial transition activities to facilitate product commercialization and regulatory compliance;

13. Leading or supporting regulatory inspections, internal audits, and CAPA development and implementation;

14. Applying data integrity principles including ALCOA+ in oversight of clinical trial documentation and records; and

15. Coordinating cross-functional teams to ensure alignment with global program strategy and regulatory compliance requirements.

Contact: Interested candidates please apply via [https://careers.amgen.com/en/search-jobs](<https://careers.amgen.com/en/search-jobs>) and search for job # R-255458.

Job type: Full-Time position. The annual salary range for this position in the U.S. is $138,320.00 - $163,992.00 per year. Also, this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation. For more details visit[https://careers.amgen.com/life-at-amgen/benefits/](<https://urldefense.proofpoint.com/v2/url?u=https-3A__nam11.safelinks.protection.outlook.com_-3Furl-3Dhttps-253A-252F-252Furldefense.proofpoint.com-252Fv2-252Furl-253Fu-253Dhttps-2D3A-5F-5Fnam11.safelinks.protection.outlook.com-5F-2D3Furl-2D3Dhttps-2D253A-2D252F-2D252Furldefense.proofpoint.com-2D252Fv2-2D252Furl-2D253Fu-2D253Dhttps-2D2D3A-2D5F-2D5Fnam11.safelinks.protection.outlook.com-2D5F-2D2D3Furl-2D2D3Dhttps-2D2D253A-2D2D252F-2D2D252Furldefense.proofpoint.com-2D2D252Fv2-2D2D252Furl-2D2D253Fu-2D2D253Dhttps-2D2D2D3A-2D2D5F-2D2D5Fnam11.safelinks.protection.outlook.com-2D2D5F-2D2D2D3Furl-2D2D2D3Dhttps-2D2D2D253A-2D2D2D252F-2D2D2D252Furldefense.proofpoint.com-2D2D2D252Fv2-2D2D2D252Furl-2D2D2D253Fu-2D2D2D253Dhttps-2D2D2D2D3A-2D2D2D5F-2D2D2D5Fcareers.amgen.com-2D2D2D5Flife-2D2D2D2D2Dat-2D2D2D2D2Damgen-2D2D2D5Fbenefits-2D2D2D5F-2D2D2D2526d-2D2D2D253DDwMGaQ-2D2D2D2526c-2D2D2D253D6HFirGB4LnuU4asVt8kNcMhC5SvBtxbjoaC4-2D2D2D2DrMbhtk-2D2D2D2526r-2D2D2D253DZzsBV9k-2D2D2D2DjttVNN1EvZst0Q-2D2D2D2526m-2D2D2D253DbXelMAn-2D2D2D2DLkr6ITgl-2D2D2D2DOVIwCkmHKYirp3gc83wvPae1SgtYIJYqwI2avmaKPLstizO-2D2D2D2526s-2D2D2D253DkeznBgK-2D2D2D2DF4tRtUWSI5ABybrJF1hszDEySq52Jge-2D2D2D2D2Mk-2D2D2D2526e-2D2D2D253D-2D2D2D26data-2D2D2D3D05-2D2D2D257C01-2D2D2D257Cjen01-2D2D2D2540amgen.com-2D2D2D257C660a28539c1044de1e4108db272cafda-2D2D2D257C4b4266a6136841afad5a59eb634f7ad8-2D2D2D257C0-2D2D2D257C0-2D2D2D257C638146845207554495-2D2D2D257CUnknown-2D2D2D257CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0-2D2D2D253D-2D2D2D257C3000-2D2D2D257C-2D2D2D257C-2D2D2D257C-2D2D2D26sdata-2D2D2D3DcYzBM3rFPl6qL6wF1v5QiaiQBXGj4x6xspFO9HqU9Vg-2D2D2D253D-2D2D2D26reserved-2D2D2D3D0-2D2D2526d-2D2D253DDwMGaQ-2D2D2526c-2D2D253D6HFirGB4LnuU4asVt8kNcMhC5SvBtxbjoaC4-2D2D2DrMbhtk-2D2D2526r-2D2D253DZzsBV9k-2D2D2DjttVNN1EvZst0Q-2D2D2526m-2D2D253DUnLMPhr-2D2D2DEGnpr9XBuHlwWv-2D2D2Dn4T7T8VuRZFDjwpT9dOvwdZKz7drSop9P1WDp591w-2D2D2526s-2D2D253Dc0sqSn-2D2D2DN3CobCiFz89Y-2D2D2Ds8tVcO-2D2D2D8OnDdCGlXU0NbgBc-2D2D2526e-2D2D253D-2D2D26data-2D2D3D05-2D2D257C01-2D2D257Crodneyj-2D2D2540amgen.com-2D2D257>)

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts

- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

- Stock-based long-term incentives

- Award-winning time-off plans

- Flexible work models, including remote and hybrid work arrangements, where possible

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

American Type Culture Collection (ATCC)

Senior Regulatory Document Specialist

Ready to shape the future of science and global health? A global nonprofit that provides trusted biological materials for science and health, **ATCC is hiring a Senior Regulatory Document Specialist** to support day-to-day regulatory compliance activities and assigned compliance projects, with excellent opportunities for career growth and professional advancement. This hybrid role in Manassas, VA, creates, reviews, maintains, and communicates governing documentation related to the receipt, handling, production, and distribution of biological materials, as well as applying for, reviewing, and releasing regulatory permits and managing restricted party screening holds regarding sales orders. The position supports regulatory submissions and audits, interprets documentation requirements, manages regulatory permit releases, and contributes to process improvements while working independently on moderately complex assignments.

**We are seeking a Senior Regulatory Document Specialist, ideally with regulatory and compliance experience supporting a regulated or quality-driven environment, who is interested in developing expertise and advancing their career within our growing compliance team.**  Join ATCC and be part of a team that supports the global scientific community with trusted, authenticated biological materials.

\#LI-Hybrid

**Responsibilities**

- **Compliance and Audit Support:**  Extract, analyze, and summarize documentation for regulatory submissions, audits, and inspections; serve as a liaison supporting auditors and internal stakeholders; apply for, review, and release regulatory permits and manage restricted party screening holds regarding sales orders.
- **Regulatory Documentation Management:**  Maintain, control, archive, and distribute regulated documents and records in alignment with GMP, quality systems, and regulatory requirements, ensuring audit readiness and data integrity.
- **Document Authoring and Review:**  Author, revise, and review SOPs, work instructions, forms, and related documentation to ensure accuracy, completeness, and alignment with internal policies and external regulations.
- **Process Governance and Continuous Improvement:**  Manage document lifecycles, approval workflows, revision schedules, and retention practices; partner cross‑functionally to improve documentation clarity, consistency, and compliance effectiveness.

**Qualifications**

- Minimum Requirement: High School Diploma and 2 years of experience.
- Demonstrated ability to work independently on moderately complex assignments, exercising sound judgment in regulated, quality‑driven environments.
- Experience managing controlled documentation within GMP, quality systems, or regulated manufacturing or bioproduction settings.
- Proficiency authoring and maintaining SOPs and related controlled documents supporting compliant operations.
- Strong attention to detail, organizational skills, and understanding of audit readiness and data integrity expectations.
- Ability to interpret regulatory requirements, manage permit applications and restricted party screening processes, and communicate documentation standards to cross‑functional teams.
- Familiarity with electronic document management systems and change control processes preferred.
- Preferred: Experience supporting audits, regulatory submissions, permit management, restricted party screening, document approval workflows, revision cycles, or retention practices.

**Benefits**

The expected salary range for this position is $60,000 to $65,000 annually. Actual compensation will be determined based on experience and qualifications as well as internal equity and alignment with market data. In addition to base salary, this role may be eligible for additional incentive compensation including regular merit increases and the corporate bonus program.

**We Invest in You**

- **Health & Wellness:**
  - Comprehensive medical coverage and company paid Life Insurance, Disability Insurance, AD&D, and paid parental leave
  - Work life balance with Paid Holidays and PTO
  - Fitness and cell phone subsidies, and additional benefits such as legal services, pet insurance and additional supplemental coverage.
  - Employee Assistance Program offering around-the-clock counseling
- **Financial security:**
  - 401(a) (6% employer contribution) and 403(b) (2% match) retirement plans
  - Exceptional career advancement opportunities, recognition, and rewards
  - Corporate bonus program
- **Mission Focused:**
  - Non-profit organization supporting critical life science research
  - We give scientists the tools they need to make discoveries that improve and save lives
  - Contribute to community involvement and social responsibility

Join ATCC, where we fuel your success, well-being, and development. We're a mission-focused non-profit Equal Opportunity Employer, celebrating a century of supporting global public health. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Shape the future of science with us.

Virginia

Immunocore

Senior Manager Preclinical Research Programme Management

Vacancy Name

Senior Manager Preclinical Research Programme Management

Vacancy No

VN887

Employment Type

Permanent

Location of role

Abingdon, UK

Department

Corporate

Key Responsibilities

The primary purpose of this role is to apply broad expertise and knowledge in programme management and related disciplines to achieve company goals in creative and effective ways. The individual will lead and drive programme management support for Preclinical (Research) programmes, to oversee the development, prioritisation and delivery of the overall Preclinical portfolio, and to establish programme management best practices and strategy for the Preclinical pipeline programmes.

Key Responsibilities

• Establish, implement, and maintain processes and infrastructure to support scenario planning, project planning and effective management for Preclinical programmes, serving as a best practice resource for the team.

• Be a leading member of the team that owns, champions, defines, and improves our programme and portfolio management processes including managing processes to provide visibility and alignment on earlier pre-portfolio programmes - facilitating their transition onto the Preclinical portfolio as they become named programmes and Preclinical programme teams are chartered.

• Partner with project leads to develop, gain approval, and execute on the project strategy and to ensure the timely achievement of deliverables.

• Lead Research portfolio initiatives such as portfolio prioritisation – ensuring engagement with key stakeholders and programme teams across the organisation.

• Partner with Competitive Intelligence to develop and lead competitive analysis in Research and ensure learnings are captured into therapeutic area and programme strategies.

• Drive/own appropriate and timely communication and engagement regarding pipeline programmes, progress and timelines to key stakeholder groups including senior management, CMC leaders, Research leaders, programme teams (internal and external) and ensure that critical programme issues are proactively communicated and understood.

• Identify programme risks and partner with team to implement mitigations.

• Drive development and implementation of consistent, repeatable and fit-for-purpose best practice processes, tools and frameworks.

• Operationalize and evolve the Research Operating Model (ROM) through engagement with scientists and stakeholders to ensure that it reflects up-to-date processes, workflows, and timelines.

• Apply skills in Operational Excellence and use of Artificial Intelligence to improve ways of working – cycle time, productivity, efficiency and overall delivery

• Mentor, coordinate and guide less senior Preclinical Programme Manager secondees who are assigned to support pipeline programmes within the Preclinical portfolio.

• Partner with Preclinical Research programme leads to ensure effective progression, governance, communication, and planning of each of the programmes in the Preclinical pipeline (from target nomination to candidate drug nomination).

• Partner with the Head of Research, Chief Technology Officer and Therapeutic Area Heads to plan the agenda for Research Portfolio Committee (RPC) governance meetings, facilitate business planning and to facilitate development of Research portfolio strategies.

• Manage and lead RPC governance meetings for assigned programs including agenda planning, ensuring effective team preparation, minute writing and actioning items for follow-up.

• Develop structured plans with timelines and resource requirements and use to forecast areas of potential delays/issues/operational needs within the Preclinical portfolio.

• Actively monitor and update pipeline programme team rosters and ensure appropriate inclusion for communications and governance meetings; ensure appropriate attendees who are critical for programme discussion are invited and drive their active participation in the RPC meetings.

• Provide structure and best practices for knowledge management of research programmes (e.g., folder management, archival of key decisions, etc.) including routine reporting of programme delivery versus plan.

• Provide support to partner programmes ensuring efficient management and documentation of partner meetings and administrative support (e.g. data transfer, database access, and project folder access).

• Ensure internal alignment of key scientific messages ahead of external (partner) communications (ad hoc, joint programme teams (JPTs) etc.).

• Support the transfer of Preclinical programmes to Development by ensuring the seamless transfer of information to the Development programme lead / team.

• Identify and aid implementation of opportunities to improve efficiency at both the individual project and portfolio level, in areas including scheduling, collaboration, data management, logistics and reporting.

• Working with Research Operations, develop tools for analysing the current and historic portfolio to allow implementation of learnings to improve efficiency.

Education, Experience and Knowledge

Essential Experience & Knowledge:

• Typically requires a Bachelor's degree and 12+ years of related experience; or equivalent experience.

• Experience as a Researcher in the biotech/pharmaceutical industry

• Experience in an R&D Project or Product Management role in the Biotech industry (at least 6+ years of relevant experience)

• Proficiency with MS Project

• Familiarity with PM tools and practices

• Strong organizational and time management skills

• Familiarity with Microsoft environment (Word, Excel, Power Point, Visio, SharePoint, Teams)

• Exceptional relationship building skills to work with internal and external stakeholders and user groups and quickly understand their needs and the scientific, clinical, and operational problems that need solving.

• Ability to influence and persuade other stakeholders by applying knowledge and expertise to drive delivery of assigned programmesdesired departmental while preserving relationships.

• Excellent attention to detail, organisational, communication and stakeholder management skills

• Highly proactive in identifying risks, raising issues, and identifying solutions within the project and predict where opportunities for improving processes may arise in the future

• Delivery-focused mindset, capable of scaling at pace, taking operational and practical ownership of projects

• Strong track record in a relevant scientific discipline

• Demonstrated ability to mentor junior team members / interns

Essential Qualifications:

• Educated to BS/ BA level or higher in life science discipline or equivalent

• Desirable: Masters/ PhD/ PharmD/ MBA in immunology, biochemistry, cell biology or related discipline

• Desirable: Formal project management training and prior experience leading cross-functional projects within Research

• PMP certification preferred but not required

About the Company

Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.

Senior Director, Global GMP/GDP Audit and Predictive Compliance Intelligence

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Senior Director, Global GMP/GDP Audit and Predictive Compliance Intelligence**

**What you will do**

Lets do this. Lets change the world. The Senior Director is the single accountable leader for Amgens global GMP/GDP audit organization and predictive compliance intelligence capability.

The role leads an integrated enterprise function combining independent audit assurance, deep Operations compliance expertise, advanced analytics, AI-enabled tools, regulatory intelligence, inspection outcomes, supplier performance, and internal quality signals.

The Senior Director is accountable for the technical depth, strategic direction, execution, and effectiveness of the global audit program while building a forward-looking capability that identifies emerging compliance risks and enables earlier enterprise intervention.

The role leads two fully integrated capabilities:

- Global GMP/GDP Audit, including internal audits of manufacturing sites, programs, and quality systems, and audits of suppliers, contract manufacturers, laboratories, distributors, and other regulated service providers.
- Predictive Compliance Intelligence, focused on identifying weak signals, forecasting compliance vulnerabilities, detecting systemic trends, and translating intelligence into audit priorities and broader risk-mitigation actions.

The function is intended to move the organization beyond retrospective identification of deficiencies toward earlier detection, prioritization, and prevention of significant regulatory and quality risks.

**Key Responsibilities**

- Serve as the single accountable leader for the global GMP/GDP audit organization and predictive compliance intelligence capability.
- Establish the strategic direction, operating model, technical standards, and multiyear roadmap for both capabilities.
- Lead the global risk-based GMP/GDP audit strategy and master audit schedule.
- Ensure the audit program maintains sufficient technical depth to evaluate manufacturing operations, laboratories, quality systems, suppliers, contract manufacturers, and distribution activities.
- Oversee audit planning, scope, execution, finding classification, reporting, CAPA assessment, effectiveness verification, escalation, and closure.
- Establish expectations for process-based, inspection-ready auditing that evaluates actual execution, system effectiveness, product impact, data integrity, and broader applicability.
- Determine when emerging risks require expanded audit scope, targeted assessments, for-cause audits, multi-site evaluation, or executive escalation.
- Build the predictive compliance intelligence capability, including its data strategy, analytical methods, technology roadmap, governance interfaces, talent model, and performance measures.
- Integrate audit data, inspection outcomes, regulatory trends, supplier performance, deviations, CAPAs, complaints, recalls, and other quality signals into a consolidated enterprise risk view.
- Develop predictive models, dashboards, early-warning indicators, and risk scenarios to guide audit priorities and proactive intervention.
- Identify systemic risks and recurring failure mechanisms across sites, suppliers, products, processes, and quality systems.
- Lead the technical capability strategy for auditors, including competency requirements, qualification standards, continuing education, and access to appropriate subject-matter expertise.
- Oversee AI-enabled audit and compliance intelligence tools.
- Ensure AI supports, but does not replace, qualified human judgment, accountable Quality decisions, audit independence, and objective evidence.
- Serve as a GMP/GDP advisor to the separate enterprise AI governance organization.
- Provide senior leadership with clear, actionable insight on emerging compliance risks and recommended interventions.
- Lead and develop a highly qualified, multidisciplinary global audit and compliance intelligence organization.
- Own the audit continuous-improvement roadmap and measures of audit effectiveness, not merely audit completion.

**Regulatory Compliance Collaboration**

The role will partner closely with:

- Regulatory Reporting and Inspection Readiness (RRIR) to apply audit and predictive intelligence to inspection readiness forums, pressure testing, mock inspections, inspection strategy, on-site inspection support, and response development for significant or multisite findings.
- Inspection Lifecycle Management (ILM) to integrate audit findings with inspection outcomes and lessons learned. ILM retains ownership of observation ratings, inspection scoring, and regulatory commitment tracking and closure.
- External Affairs to monitor emerging health-authority policy, enforcement priorities, and regulatory trends and translate them into audit, surveillance, and compliance priorities.

**Measures of Success**

- The global audit program demonstrates increased technical depth, challenge, consistency, and inspection relevance.
- Predictive compliance intelligence is established as a credible and actionable enterprise capability.
- The function identifies meaningful risks that would not have been detected through the routine audit program alone.
- Significant risks are identified before they result in major inspection, product, supply, or compliance events.
- Audit, inspection, commitment, supplier, quality, and external regulatory intelligence are integrated into a common enterprise risk view.
- Audit scope and priorities respond dynamically to predictive signals, inspection outcomes, supplier performance, and external regulatory trends.
- Audit intelligence strengthens RRIR inspection readiness and response strategy.
- ILM receives timely audit information to support inspection scoring, lessons learned, and commitment oversight.
- Recurring findings decrease, systemic issues are identified earlier, and corrective actions are sustainable.
- Auditor technical capability improves against defined competency standards.
- AI-enabled tools improve risk detection and audit effectiveness while maintaining human accountability and audit independence.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The dynamic leader we seek is an individual with these qualifications

**Basic Qualifications:**

- Doctorate degree and 5 years of biologics manufacturing and regulatory compliance experience OR
- Masters degree and 9 years of biologics manufacturing and regulatory compliance experience OR
- Bachelors degree and 11 years of biologics manufacturing and regulatory compliance experience

AND

In addition to meeting at least one of the above requirements, you must have at least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above

**Preferred Qualifications:**

- Significant leadership experience in pharmaceutical or biotechnology Quality, auditing, compliance, manufacturing, regulatory affairs, analytics, or related disciplines.
- Demonstrated depth in Operations GMP/GDP compliance and the ability to independently evaluate complex manufacturing, laboratory, quality-system, supplier, and distribution risks.
- Experience leading a global audit, supplier-quality, inspection-readiness, quality-system, or compliance-intelligence organization.
- Demonstrated experience building or substantially transforming an enterprise capability, program, or operating model.
- Experience applying analytics, AI, or digital tools to compliance and risk management.
- Strong knowledge of global health-authority inspection expectations and enforcement trends.
- Demonstrated ability to identify emerging risk, make difficult compliance judgments, and influence enterprise decisions.
- Demonstrated ability to lead multidisciplinary teams and senior cross-functional stakeholders.

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

District of Columbia

Global Regulatory Affairs Director - Inflammation and Rare Disease

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Global Regulatory Affairs Director - Inflammation and Rare Disease**

**What you will do**

- Lets do this. Lets change the world. Amgen is seeking a Regulatory Affairs Director supporting products in the Inflammation and Rare Disease Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules.

- In this vital, product-facing role you will lead the Global Regulatory Team (GRT) in the Regulatory Affairs organization. The role of the Regulatory Affairs Director is to lead GRTs within Amgens Regulatory organization, develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions, and to provide regulatory expertise and guidance to product teams.

- Key Responsibilities:

- Develop and execute the global regulatory product strategy

- Lead GRTs

- Represent Regulatory on the product team and other key commercialization governance bodies

- Develop Global Regulatory Strategic Plan and provide regulatory input into the products Global Strategic Plan. Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. Identify and communicate regulatory risks

- Represent GRA on the product team

- Develop registration strategies and plans aimed at achieving regulatory approval and product labeling

- Provide regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent

- Lead the planning and implementation of global regulatory filings (e.g. clinical trial applications, marketing applications, label extensions, CMC changes)

- Ensure consistency of evidence-based global product communication (e.g. regulatory submission documents)

- Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment

- Ensure guidance on regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, conditional /accelerated approval, compassionate use and pediatric plan) is assessed and incorporated into the global regulatory strategy

- Communicate consistently well defined, successful regulatory strategies throughout the organization such that expectation is understood

- Ensure effective regulatory agency communications by leading core regulatory and cross functional teams (e.g. GRTs, filing teams)

- Attend key regulatory agency meetings which could impact the global product strategy

- Represent Amgen Regulatory on external partnership teams at the product level

- undefined

**What expect of you**

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

**Basic Qualifications:**

Doctorate degree and 4 years of regulatory experience in biotech or science

**Or**

Masters degree and 7 years of regulatory experience in biotech or science

**Or**

Bachelors degree and 9 years of regulatory experience in biotech or science

**Preferred Qualifications:**

- Ability to lead and build effective teams

- Strong communication skills - both oral and written

- Ability to understand and communicate scientific/clinical information

- Ability to anticipate and mitigate against future strategic issues & uncertainties

- Ability to resolve conflicts and develop a course of action

- Cultural awareness and sensitivity to achieve global results

- Planning and organizing abilities

- Able to prioritize and manage multiple activities

- Ability to make complex decisions and solve problems

- Ability to deal with ambiguity

- Negotiation skills

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Nurix Therapeutics

Senior Research Associate, Preclinical Pharmacology

**Senior Research Associate, Preclinical Pharmacology**

*Run in vivo studies that move Nurix's degrader programs toward the clinic. You'll execute mouse efficacy, PK/PD, and mechanism-of-action studies in oncology and inflammation models and generate the Western blot and flow cytometry data that show how our molecules work.*

**Position Description**

**The Opportunity**

- Join the Research – Preclinical Pharmacology team as a full-time, onsite, hands-on member, reporting to a Scientist / Principal Scientist, Preclinical Pharmacology
- Perform mouse handling and in-life procedures, including dosing by oral (PO), intraperitoneal (IP), subcutaneous (SC), and intravenous (IV) routes, tumor cell implantation, tumor and body-weight measurements, and in-life and terminal blood collection
- Execute PK/PD, tolerability, and efficacy studies in oncology xenograft/syngeneic models and in murine models of inflammation, under the direction of study leads
- Prepare and formulate test articles and vehicles for dosing; monitor animal health, document observations, and escalate adverse events promptly
- Perform necropsy and collect, process, and bank tissues and blood for downstream biomarker and pharmacodynamic analyses
- Prepare tissue and cell lysates and perform Western blotting (including quantitative and automated capillary formats) to measure target degradation and pathway modulation
- Develop, run, and analyze multi-color flow cytometry panels for immune and tumor-cell phenotyping from blood, spleen, tumor, and other tissues
- Maintain and expand cell lines using sterile cell culture technique; support cell-based assays and the generation of cells for in vivo implantation
- Record experiments accurately and in a timely manner in the electronic lab notebook; analyze, graph, and summarize data and present results at team meetings
- Collaborate with Biology, Chemistry, DMPK, and Translational teams to design studies and troubleshoot models and assays
- Adhere to IACUC protocols, animal welfare regulations, and laboratory safety requirements, and maintain required training and certifications
- Contribute to the optimization and qualification of new models and assays and to the training of junior team members
- Maintain laboratory equipment and supplies and support vivarium coordination, including occasional weekend or off-shift study coverage; other essential duties as assigned; minimal travel (\<5%)

**What You’ll Bring**

- BS/MS in Biology, Pharmacology, Immunology, Cancer Biology, or a related field, with a BS or equivalent plus 8 or more years of relevant experience, or an MS plus 4 or more years of relevant experience
- Industry (biotech or pharma) experience conducting in vivo pharmacology studies in mice
- Proficiency in mouse handling and dosing by PO, IP, SC, and IV routes, as well as blood collection and tissue harvest
- Hands-on experience with oncology models (e.g., xenograft, syngeneic) and with murine models of inflammation or immunology
- Demonstrated proficiency in Western blotting and flow cytometry, including sample preparation, staining, and data analysis
- Proficiency in sterile mammalian cell culture technique
- Working knowledge of IACUC regulations and humane animal care practices
- Strong organizational and documentation skills, with attention to detail and the ability to manage multiple studies simultaneously
- Collaborative, adaptable, and comfortable in a fast-paced, team-oriented research environment
- Ability to work in an animal facility and tolerate exposure to laboratory animals, and to work occasional weekends or off-shift hours as studies require
- Bonus: experience with targeted protein degradation (molecular glues, PROTACs) or other small-molecule oncology or immunology programs
- Bonus: experience with multi-spectral flow cytometry, automated Western (e.g., Jess/Wes), ELISA, or MSD cytokine/biomarker assays
- Bonus: experience with orthotopic, disseminated, PDX, or humanized mouse models, or with in vivo imaging
- Bonus: experience with inflammation models such as collagen-induced arthritis, colitis, or cytokine-challenge models
- Bonus: familiarity with PK/PD relationships, compound formulation, and dose-response study design
- Bonus: proficiency with GraphPad Prism and electronic lab notebook systems

**Salary Range:**  $131,400 - $139,900

*The posted range applies to roles based in the San Francisco Bay Area and reflects local market conditions. Where an offer lands within that range depends on the candidate’s relevant experience, technical expertise, and how their background aligns with the role’s requirements.*

**Location:** Onsite – Brisbane, CA

**Fit with Nurix Culture and Values**

- Strong team orientation; highly collaborative
- Solutions and results-oriented focus
- Hands-on approach; resourceful and open to diverse points of view

**About Nurix Therapeutics**

*Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.*

Senior Engineer System Owner Compliance

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**SENIOR ENGINEER, SYSTEM OWNER COMPLIANCE**

**What you will do**

Lets do this. Lets change the world. In this vital role you will partner across Facilities & Engineering, Manufacturing, Quality, Validation, Environmental Health & Safety, Supply Chain, Digital Technology & Innovation, and Capital Projects to ensure engineering activities support operational excellence while maintaining a constant state of inspection readiness.

The successful candidate will demonstrate strong engineering judgment, ownership, technical leadership, and a continuous improvement mindset while driving compliance, reliability, and exceptional customer service.

- Provide system ownership for Biopharmaceutical compliance programs. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
- Develop equipment maintenance programs, ensure the availability of spare parts, and coordinating maintenance execution as necessary to ensure systems are in proper working order.
- Ensure systems are installed and operating safety and comply with pertinent environmental health/safety practice, rules and regulations.
- Ensure necessary commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors as necessary.
- Monitor systems to identify performance risks and implement risk reduction strategies.
- Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
- Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
- Facilities Quality & Compliance
- Serve as the technical lead for Facilities Quality & Compliance programs supporting GMP manufacturing operations.
- Ensure facility systems, utilities, maintenance programs, engineering activities, and documentation remain compliant with cGMP regulations, Amgen standards, and engineering requirements.
- Maintain Facilities & Engineering in a continuous state of inspection readiness through proactive compliance monitoring and risk mitigation.
- Partner with Quality Assurance during internal audits, corporate audits, customer audits, and regulatory inspections.
- Quality Systems Ownership
- Own facility-related Deviations from initiation through closure, including investigation leadership, root cause analysis, effectiveness verification, and timely implementation of corrective actions.
- Lead structured investigations using risk-based methodologies including 5-Why, Fishbone, Kepner-Tregoe, and Human Performance principles.
- Own engineering Change Controls, ensuring appropriate impact assessments, stakeholder alignment, and compliant implementation.
- Own & Manage Deviations from initiation through timely closure, ensuring sustainable corrective and preventive actions.
- Manage CAPAs from initiation through effectiveness verification, ensuring sustainable corrective and preventive actions.
- Monitor quality metrics, identify emerging compliance trends, and proactively mitigate risks.
- Engineering & Maintenance Excellence
- Support commissioning, qualification, startup, and lifecycle management of facility systems and utilities.
- Develop and approve engineering procedures, maintenance strategies, technical reports, and risk assessments, as needed.
- Ensure engineering documentation complies with Good Documentation Practices (GDP).
- Continuous Improvement
- Champion a continuous improvement mindset by simplifying processes, reducing compliance risk, improving equipment reliability, and enhancing operational performance.
- Lead improvement initiatives utilizing Lean, Six Sigma, Operational Excellence, and data-driven decision making.
- Business Partnership
- Build trusted partnerships across Manufacturing, Quality, Validation, EHS, Supply Chain, and Engineering.
- Demonstrate a proactive, customer service mindset by delivering responsive engineering solutions while balancing compliance, reliability, and business needs.
- Influence cross-functional teams without direct authority while fostering ownership, accountability, and collaboration.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The Professional we seek is a person with these qualifications.

**Basic Qualifications:**

- High school diploma / GED and 10 years Engineering experience OR
- Associates degree and 8 years of Engineering experience OR
- Bachelors degree and 4 years of Engineering experience OR
- Masters degree and 2 years of Engineering experience OR
- Doctorate degree

**Preferred Qualifications:**

- Bachelors degree in Chemical or Mechanical Engineering
- 6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment
- Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Data Analytics, Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
- Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
- Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects
- Understanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
- Understanding of safety requirements working in a GMP Biopharmaceutical Production facility.
- Independent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork
- Great teammate prepared to work in and embrace a team based culture that relies on collaboration for effective decision-making
- Strong leadership, technical writing, and communication/presentation skills
- Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage
- Ability for domestic/international travel

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.