Regulatory

AbbVie

Senior Manager, Regulatory Affairs

Company Description

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.co.uk](<https://www.abbvie.co.uk/>). 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

- Located in Maidenhead (3 days per week Tuesday, Wednesday, Thursday)
- Aligned with Neuroscience business unit
- Excellent benefits and opportunities to progress

**Job Overview**

- Acts as the primary Regulatory contact for identified therapeutic area of responsibility.
- Provides line management responsibility for a small team within UK Regulatory Affairs, including recruitment, goal setting, performance appraisal and talent development.
- Oversees all regulatory activities within therapeutic area of responsibility, including maintaining licensing whilst contributing to the Brand Team priorities.
- Uses experience and knowledge of the regulatory landscape to guide team to develop robust regulatory strategies and timely submissions to the Medicines and Healthcare Products Agency (MHRA), ensuring the fastest approvals, implementations and product launches.
- Develops and maintains relationships with Area & Affiliate members of GRS Europe and cross functional partners share knowledge, increase regulatory awareness and build networks.
- Engages externally with the Health Authority on regulatory submissions and/or other pharmaceutical industry trade associations, as required.
- Supports the business in planning for and execution of product launches, acquisitions and divestitures, as required.

**Key Accountabilities**

**Regulatory Strategy and Tactical Implementation**

- Provides clear guidance and recommendations on UK regulatory strategies and tactical plans throughout a product lifecycle including clinical trial submissions, management of variations, paediatric investigation plans, new marketing authorisation applications and liaison with local regulatory authorities.
- Reviews regulatory submissions for UKRA team for assigned areas of responsibility, corrects where necessary and provides feedback.
- Regulatory intelligence and external landscape monitoring,
  - Interacts with Regulatory policy makers and professional associations (eg ABPI) to gather knowledge about trends, future changes and current landscape in accordance with the national and EU legislation and relevant Associations’ Codes and advocate for AbbVie’s interests.

**Regulatory Compliance**

- Ensures compliance with AbbVie’s policies and procedures to meet statutory, quality and business requirements, acting as primary point of regulatory contact for audits and inspections in the UK as appropriate and supporting oversight of divisional policies and procedures.
- Ensures compliance with UK legislation for Medicines, Medical Devices, clinical trials and paediatric investigation plans and has an awareness of the ABPI code.

**Liaison with Internal Stakeholders**

- Acts as Regulatory liaison with Area and local UK cross functional teams to ensure UK strategies align with global strategies, whilst maintaining compliance with local regulations.
  - Understand and articulate the regulatory perspective across the business, translating key regulatory decisions in terms of impact on products in the UK.
- Acts as lead Regulatory representative on Affiliate committees/initiatives (as required).
- Acts as deputy to the UK Regulatory Affairs Managers and/or Director (as required).

**Leadership for UK Regulatory Therapeutic team**

- Provides strong leadership and direction to the UK Regulatory Therapeutic Regulatory team to support:
  - Successful implementation of regulatory product strategies
  - Develops and maintains strong working relationships with MHRA and local pharmaceutical company trade associations
  - Process improvements, internal compliance and team consistency
  - Individual professional development, improved capability and upskilling within team
  - Supports recruitment activities (as required) and retain high calibre regulatory affairs professionals

Qualifications

- Experienced Regulatory professional in the pharmaceutical industry with a clear understanding of the UK regulatory and submissions process
- Experience as a line manager with highly developed people skills
- Sense of personal responsibility and accountability, with a positive, can-do attitude
- Ability to multitask, prioritise, and manage multiple projects and deadlines
- Ability to work effectively and collaboratively across cultures and cross-functionally
- Strong diplomacy, influencing, presentation skills

**Personal Skills**

- Consultative and collaborative interpersonal style
- Excellent written, verbal and interpersonal skills (in English)
- Ability to identify compliance risks and escalate when necessary
- Life Sciences Degree in relevant subject area
- Computer literate

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

Principal Research Scientist I, In Vivo Antibody Discovery

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 Biotherapeutics and Genetics Medicine department within Discovery Research is seeking a highly motivated Principal Scientist to join the in vivo antibody discovery team at AbbVie Bioresearch Center (ABC). The ABC site in Worcester, MA, offers a unique setting where Biotherapeutics discovery, development and manufacturing coexist in one location. The team partners with multidisciplinary groups across AbbVie focused on developing therapies for Immunology, Neuroscience, and Oncology. We utilize innovative approaches for antibody discovery including custom immunization strategies, advanced multiplex screening assays, and best-in-class automation platforms to enable successful antibody discovery against challenging targets.

As a member of the in vivo antibody discovery group, you will be responsible for leading innovative immunization-based antibody discovery. You will provide technical and strategic leadership across multiple immune discovery platforms, driving the identification of high-quality therapeutic antibody candidates for challenging targets and advanced antibody modalities. The successful candidate will combine deep expertise in antibody discovery technologies with strong program leadership, cross-functional collaboration, and external partner management.

**Key Responsibilities**

- Lead antibody discovery programs from hit identification, screening, lead selection, and candidate nomination.

- Design and execute novel antigen engineering strategies and immunization approaches, to maximize immune response quality and diversity.

- Provide technical leadership across multiple antibody discovery platforms, including B cell-based discovery, immune repertoire screens and hybridoma

- Lead identification of antibody and VHH modalities for diverse therapeutic programs and multispecifics.

- Evaluate and implement emerging antibody discovery technologies, including AI-enabled workflows, machine learning, computational biology, and laboratory automation, to expand platform capabilities and accelerate discovery.

- Direct hybrid discovery campaigns that integrate internal capabilities with external partners while proactively identifying and mitigating scientific/ operational risks.

- Mentor scientists and provide technical guidance across antibody discovery programs.

- Contribute to the scientific reputation of the organization through publications, patents, presentations, and external collaborations.

Qualifications

- BS, MS, or PhD in immunology, biochemistry, molecular biology, bioinformatics or a related scientific field with typically 6+ (PhD), 12+ (MS), or 14+ (BS) years of industry experience.
- Deep hands-on expertise in antibody discovery platforms, such as single B cell cloning, immune repertoire screening and hybridoma.
- Extensive experience designing antigens and novel immunization strategies for challenging therapeutic targets.

- Strong expertise in hit identification, screening cascade design, lead triage, and lead selection.

- Experience with VHH discovery platforms using camelids and transgenics.

- Working knowledge of antibody engineering principles, developability assessment, and sequence liability evaluation.

- Adept at identifying and working with novel solutions—such as AI-based antigen design, and laboratory automation.

- Demonstrated ability to critically evaluate and implement new antibody discovery technologies and methodologies.

- Team player with proven flexibility to deal with changing timelines and shifting work priorities.

**Desired**

- Experience with rabbit antibody discovery workflows.

- Knowledge of bioinformatics pipelines and concepts used to analyze NGS data.

- Familiarity with computational antibody discovery, AI/ML-enabled design, and laboratory automation technologies.

- Proven ability to lead multidisciplinary discovery teams across biology, protein sciences, engineering, computational sciences, and project management.

- Strong organizational and project leadership skills with demonstrated success delivering complex discovery programs.

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 and 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>)

Massachusetts

Principal Research Scientist II, Process Chemistry

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

AbbVie Process Chemistry is responsible for the chemical development of AbbVie’s clinical candidates. We are looking for a highly motivated Principal Research Scientist II who can make scientific contributions and develop strategies, timelines and key activities across drug substance modalities, including small molecules. The candidate must be able to mentor and develop staff with experimental approaches to solve difficult scientific and technical challenges. The candidate will be an integral part of project teams and will be responsible for developing the synthetic process and executing activities required for drug substance process development. Working with cross-functional colleagues, the candidate will develop productive collaborations and communications with scientific teams.

**Responsibilities:**

- The candidate will participate and/or lead project teams associated with drug substance process development and characterization.
  - Develop and characterize drug substance processes in the laboratory and translate them to scalable processes.
  - Proactively advise and share knowledge and expert opinions with subordinates, peers, and senior management. Mentor staff in troubleshooting strategic and experimental issues.
  - Author and review key regulatory documents, laboratory data, technical memos and reports.
- The position involves multi-disciplinary interactions with organic chemists, analytical chemists, engineers, drug product development, and program management.
- The candidate will identify and nurture ideas for continuous improvement activities and initiatives within the department.
- The candidate will be responsible for setting project strategies, defining project responsibilities and timelines, developing control strategies, providing leadership in a matrixed team setting and developing robust processes for cGMP manufacturing.

Qualifications

- BS (16+ years); MS (14+ years) or PhD (8+ years) in Chemistry or allied field, with 8+ years of previous work experience in a pharmaceutical laboratory setting.
- Proven scientific leadership; strong interpersonal and communication skills for facilitating collaborations and a demonstrated ability to lead cross-functional process development teams.
- Experience with GMP drug substance manufacturing and process development.
- Experience in managing and developing scientific leaders.
- The successful candidate will have a strong understanding of modern organic chemistry, mechanistic theory, process development, control strategy development, and regulatory starting material strategies.

*Key AbbVie Competencies:*

Interacts well with diverse groups within function and maintain strong working relationships with internal and external collaborators to enable higher performance.

- Learns fast, grasps the "essence" and can change course quickly where indicated.
- Raises the bar and is never satisfied with the status quo.
- Creates a learning environment, open to suggestions and experimentation for improvement.
- Embraces the ideas of others, nurtures innovation and manages innovation to reality.

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 thisposting 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 anduntil 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

Principal Research Scientist I/II Biologics Quality Control in Biologics Analytical R&D (all

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

People. Passion. Possibilities. Three words that make a world of difference.

More than a job. It's a chance to make a real difference.

Welcome to AbbVie! As part of an international company with 58,000 employees worldwide and around 3,500 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? Youve come to the right place!

**Together, we break through –** as Principal Research Scientist I/II Biologics Quality Control in Biologics Analytical R&D (all genders)

The Principal Scientist I/II will be an integral part of the Analytical Innovation and Mass Spectrometry Team in the Bio CMC division. The role involves supporting analytical aspects of biologics products with a focus on advancing AbbVie’s early-stage clinical programs. This position calls for an individual with a strong technical analytical background, demonstrated leadership skills and the ability to effectively communicate and work cross-functionally.

**Make your mark:**

- Lead and mentor scientists specializing in separation-based assays including HPLC and capillary electrophoresis for sample testing to support biologics mab and DS process development, characterization, validation as well as GMP manufacturing investigation activities.
- Serve as analytical representative in AbbVie's CMC teams, supporting early-stage biologics pipeline assets. Balance stakeholder expectations to ensure effective collaboration.
- Serve as the subject matter expert for analytical test methods, providing expertise and support for method development, execution, and troubleshooting.
- Evaluate and select effective analytical technologies and methods to meet program needs. Support automation and development of high-throughput analytical methods and drive timely delivery of high-quality testing results.
- Participate in the preparation and review of technical documents for early-stage programs. Take responsibility for analytical test methods, their development and validation, test method transfer to internal and external partners, as well as perform batch release activities
- Collaborate with other analytical teams in R&D and PDS&T on program transition, workflow and program strategic alignment. Provide guidance to peers on project management, analytical strategy, and technical skills related to separation techniques.
- Communicate project data, issues and risks to relevant teams. Promote proactive risk resolution within and across functional areas to advance project objectives.
- Demonstrate scientific excellence, advance science and innovation. Implement novel analytical techniques to enhance method robustness and expand analytical capabilities.

Qualifications

**This is how you make a difference:**

- PhD in chemistry, biology, biochemistry, chemical engineering, or related technical discipline. Minimum of 8+ years (PhD) of professional experience working in biotech/pharmaceutical setting.
- Proven experience managing and leading analytical development and QC activities for biologic development, including mAbs, multi-specifics, antibody-drug conjugates, and fusion proteins.
- Experience in the role of Head of Quality Control (HQC) according to § 12 AMWHV is a plus
- Expertise in protein and impurity analysis techniques such as HPLC, capillary electrophoresis, and other relevant methods. Experience with mass spectrometry and ELISA is a plus.
- Skilled in technical writing including experience in authoring, reviewing documents with regulatory impact
- Strong people leadership skills and demonstrated ability to foster an engaging, inclusive and collaborative team environment.
- Excellent communication and interpersonal skills, effectively managing relationships to enhance team decision-making.
- Ability to work effectively across functions, anticipating and addressing overall program development needs.
- Ability to quickly comprehend and adapt to new situations, with an open mindset and can-do attitude, demonstrating agility where necessary to address evolving project needs.
- Ability to think critically and demonstrate troubleshooting and problem-solving skills.
- Ability to lead and manage multiple projects of significant scope and complexity, while meeting all deliverables and timelines.
- An independent, self-motivated, proactive individual who thrives in a fast-paced team environment.

**What we offer you:**

- with a diverse work environment where you can have a real impact
- with an open corporate culture
- with an attractive salary
- with an intensive onboarding process with a mentor at your side
- with flexible work models for a healthy work-life balance
- with a corporate health management that offers comprehensive health and exercise programs
- with company social benefits
- with a wide range of career opportunities in an international organization
- with top-tier, attractive development opportunities
- with a strong international network

At multiple times, we have been globally recognized as a "Great Place to Work" and we are proud to provide our employees with the flexibility to maintain a healthy work-life balance. We take our impact on the environment, and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality, equity, diversity and inclusion (EED&I) – a commitment that is fundamental to us. This includes appreciating different perspectives, creating an inclusive culture and treating all employees with dignity and respect.

At AbbVie, your individual contributions count – help us move mountains together. Be a part of our success, grow with us and accomplish more than you could have imagined. Sounds like the perfect career opportunity for you? We look forward to receiving your application! All you need is a complete CV – we will discuss everything else with you in person.

Any questions? Feel free to email TalentAcquisition.de@abbvie.com– We look forward to hearing from you!

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>)

Clinical Research Associate II

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

PRIMARY FUNCTION/OBJECTIVE

To enable AbbVie’ s emergence as a world class R&D organization, the position anticipates and proactively solves study-related clinical site issues as they occur and initiates, recommends and communicates corrective action ensuring successful protocol level execution of CSM deliverables involving start-up, execution, and close-out of studies.

CORE JOB RESPONSIBILITIES

- Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol.
- Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research.
- Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes.
- Overviews the overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives. proactively manages the site and ensures action plans are put into place as needed to ensure compliance.
- Ensures regulatory inspection readiness at assigned clinical sites.
- Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
- Ensures safety and protection of study subjects through compliance with the study monitoring plan, AbbVie SOPs, ICH Guidelines, and applicable regulations.
- Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
- Manages investigator payments as per executed contract obligations.
- Negotiates investigator/ hospital agreements with stakeholders.
- Maintain and complete own expense reports as per local and applicable guidelines.
- Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.

Qualifications

- Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing) preferred.
- Site Monitoring Experience: Minimum 3 years.
- Experience in on-site monitoring of investigational drug or device trials is required.
- Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
- Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
- Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
- Ability to work, understand and follow work processes within the assigned function.
- Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity.
- Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated.
- Ability to use functional expertise and exercise good judgment.
- Demonstrated business ethics and integrity.

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>)

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

Purpose:

Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into

medicine for our patients and leveraging new advanced capabilities to drive industry leading

performance.

Partners with the investigator and site staff for meaningful and effective engagements positioning

AbbVie as the choice in clinical trials.

Focus on site clinical research that ensures appropriate conduct of the trial while driving

improvement in data integrity, compliance, overall study performance and customer experience.

Responsibilities:

- Considered as the primary point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie’s positioning.
- Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.
- Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.
- Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.
- Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey.
- Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
- Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager.
- Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
- Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.
- Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
- Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. Ensures audit and regulatory inspection readiness at assigned clinical site at all times. Manages investigator payments as per executed contract obligations, as applicable.

Qualifications

- Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred.
- Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. Familiar with risk‐basedmonitoring approach, onsite and offsite monitoring.
- Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
- Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
- Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.
- Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
- Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.
- Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.
- Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues.
- Acts with integrity in accordance with AbbVie code of business conduct and leadership values.
- Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.

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>)

Principal Research Scientist I

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

**Purpose**

We are seeking a highly-motivated toxicologist to support discovery-stage programs across therapeutic areas within preclinical safety. As part of the Investigative Toxicology and Pathology group, the successful candidate will effectively leverage in silico, in vitro, and in vivo tools to design and execute a safety assessment strategy to support pipeline advancement. As project toxicologist, this scientist will work cross-functionally, providing critical subject matter expertise and data integration to drive progress for programs.

**Responsibilities**

- Support project teams to design and execute a safety strategy specific to the needs of the project by leveraging internal and external resources, in silico tools, in vitro models, and in vivo studies. Select and design experiments that answer key questions, are decision-enabling, and promote judicious progression of programs.

- Support development and deployment of in vitro tools for safety assessment (simple and complex in vitro models, or NAMs) and utilize appropriate endpoints (imaging, toxicogenomic, etc) to support decision-making.

- Demonstrate the ability to identify and resolve key project hurdles by effectively utilizing available information and resources.

- Communicate effectively across cross-functional teams and with leadership to support alignment on program strategy.

- Proactively seek out new information in the literature and incorporate this into individual projects as well as the overall safety assessment strategy.

- Seize opportunities to pursue project-relevant exploration and experiments to support data-driven decision-making and program progress.

- May mentor/supervise a team of one or more and evaluate the performance of those individuals; accountable for the effective performance of the team/individuals.

- Collaborate effectively with other teams to identify areas of scientific advancement and efficiency.

Qualifications

**Required:**

- Bachelor’s Degree or equivalent education and extensive, typically 14+ years of experience, Master’s Degree or equivalent education and typically 12 years of experience, PhD and typically 6+ years of experience.
- Experience directing the use of, and interpreting data from, in vitro safety studies.
- Demonstrate ability to function independently, generating original research or development strategies.
- Possess thorough theoretical and practical understanding of own scientific discipline.
- Effective writer and communicator of research. Demonstrated scientific communication and presentation skills.

**Preferred:**

- People leadership and management experience
- DABT board certification or equivalent
- Experience working on cross-functional project teams, including but not limited to, within pharmaceutical development

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>)

Senior Statistician, Research

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**

We are seeking a motivated and technically strong statistician to join our DSS team in China. In this role, you will support statistical planning, analysis, and China regulatory interaction/submissions for clinical trials conducted in China and globally. This position is ideal for recent graduates or individuals transitioning into the pharmaceutical industry, who are eager to learn and contribute to meaningful healthcare innovations. You will work under the guidance of experienced statisticians and cross-functional teams to develop hands-on skills in drug development.

**Major Job Responsibilities**

- With supervision, assist in the development of clinical trial protocols and statistical analysis plans (SAPs) with details for programming implementation.
- Support study design elements such as sample size estimation, randomization strategy, and endpoint definitions
- Assist in identifying scientifically appropriate data collection instruments or fit-for-purpose data sources. With supervision provide programming specifications for derived variables and analysis datasets. Assist Data Science in preparing for database lock
- With supervision perform statistical analyses as per the analysis plan. Collaborate with Statistical Programming to ensure the delivery of high-quality outputs according to agreed-upon timelines.
- With supervision, provide appropriate interpretation of statistical deliverables in collaboration with other functions. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures.
- Collaborate effectively with both Global and China-based teams, acting as a communication bridge to align statistical deliverables and ensure mutual understanding of clinical and regulatory expectations.
- Participate in local regulatory deliverables including statistical review documentation
- Explore and apply AI-powered tools to solve business problems, increase productivity and improve effectiveness under supervision.

Qualifications

**Qualifications**

- MS (with 4+ years of experience) or Ph. D degree in Statistics, Biostatistics, Applied Mathematics, or a related field
- Familiarity with at least one statistical programming language (e.g., SAS, R, Python)
- Solid foundation in statistical concepts and basic clinical trial design principles
- Able to perform statistical computations and simulations
- Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others
- Able to build strong relationship with peers and cross-functional partners to achieve higher performance.
- Excellent written and verbal communication skills in both Mandarin and English.
- A proactive learner with strong ability to work in a team-based environment.

**Preferred Qualifications**

- Internship or academic project experience related to clinical data, healthcare analytics, or predictive modeling
- Understanding of CDISC standards or regulatory framework (eg, ICH guideline)
- Exposure to AI-based tools or programming libraries

**Key Stakeholder:**

- Clinical development experts
- Statistical programmers
- Data science experts
- Regulatory affair experts

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>)

Tris Pharma

Product Development Research Scientist II

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company focused on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have \>150 US and International patents and market several branded ADHD products in the US. We also license our products in the US and ex-US markets. Our robust pipeline of innovative products employing our proprietary science and technology spans neuroscience and other therapeutic categories.

Our science and technology make us unique, but our team members set us apart; they’re the engine fueling Tris’ passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company’s success. Equally important is how we interact on a daily basis. We believe in each other and in respectful, open and honest communication to help support individual and team success.

We have an immediate opening at our Monmouth Junction, NJ facility for two (2) Product Development (PD) Research Scientists II to join our Platform and Product Feasibility (PPF) team.

The PD Research Scientist II plans and executes pre-formulation and formulation activities, contributing to development of novel drug delivery platforms and differentiated products from conceptualization to pilot proof of concept (PoC) thereby creating commercially viable intellectual property (IP). The incumbent also plans and executes pilot-phase process development activities and manufacture of current Good Manufacturing Practices (cGMPs) pilot batches, including all required documentation. The incumbent also collaborates with Analytical and Project Management to ensure project timelines and study milestones are met. She/he prepares technical reports including, but not limited to: feasibility reports, invention disclosures, early phase regulatory submission documents etc.

Primary responsibilities include:

- Carries out responsibilities in accordance with the organization’s policies, Standard Operating Procedures (SOPs), and state, federal and local laws
- Plans and executes pre-formulation and formulation activities with good scientific standards to assess feasibility of novel drug delivery platforms and differentiated products from conceptualization to pilot proof of concept (PoC); generates supporting data for Intellectual Property (IP) and creates relevant invention disclosure forms
- Plans, coordinates and executes cGMP pilot batches, including protocols, master batch records and reports, under the guidance of senior staff
- Documents all study details and results in laboratory notebooks and batch records compliant with current Good Documentation Practices (GDPs) and cGMP; Summarizes data, discusses results and makes conclusions in technical reports
- Performs physical and chemical characterization in liaison with analytical teams
- Ensures cleanliness and functioning of lab areas and proper maintenance of equipment and instruments
- Collaborates with Analytical and Project Management to ensure project timelines and study milestones are met; Presents and updates project status and issues/challenges to management
- Collaborates with, and assists, Clinical Development with the coordination of pilot PK studies, including protocol review, submission of pilot batches to Contract Research Organizations (CROs), Pharmacokinetics (PK) data review and understanding
- Authors regulatory submission documents for Pre-Investigational New Drugs (Pre-INDs) and Investigational New Drug Applications (INDs), covering pre-formulation and formulation development
- Creates and revises SOPs, as needed
- Collaborates with Quality Assurance (QA) on investigations, Corrective Action Preventive Action (CAPAs) and Change Controls to ensure timely closure

Requirements

Required Qualifications:

- Masters degree in Pharmaceutical Sciences/Pharmaceutics/Industrial Pharmacy or related scientific discipline AND 3-5 years experience in a product development or formulation laboratory in the pharmaceutical or biotechnology industry OR
- Ph.D. degree in Pharmaceutical Sciences/Pharmaceutics/Industrial Pharmacy or related scientific discipline AND 0-2 years experience in a product development or formulation laboratory in the pharmaceutical or biotechnology industry REQUIRED
- Hands on experience in designing and conducting pharmaceutical formulation and process development studies with high scientific rigor, supporting multiple dosage forms (i.e., solid, liquid and/or extended release, etc.) REQUIRED
- Good understanding of Physical Pharmacy and Pharmaceutics REQUIRED
- Good technical writing skills, including SOPs, investigations, protocols, reports REQUIRED
- Working knowledge of Food and Drug Administration (FDA), Occupational Safety and Health Administration (OSHA), Drug Enforcement Administration (DEA), cGMPs and GLPs regulations and guidances REQUIRED

Anticipated salary range:

Masters degree and 3-5 years experience - $ 90 to $ 115K/yr.

PhD degree and 0-2 years experience - $ 85 to 110K/yr.

Base salary offered is contingent on assessment of candidate’s education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups.

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-office

New Jersey

Associate Director/Director, Regulatory Affairs Advertising & Promotions

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company focused on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have \>150 US and International patents and market several branded ADHD products in the US. We also license our products in the US and ex-US markets. Our robust pipeline of innovative products employing our proprietary science and technology spans neuroscience and other therapeutic categories.

Our science and technology make us unique, but our team members set us apart; they’re the engine fueling Tris’ passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company’s success. Equally important is how we interact on a daily basis. We believe in each other and in respectful, open and honest communication to help support individual and team success.

We have an opening in our Monmouth Junction, NJ office for an experienced Associate Director or Director, Advertising & Promotions to join our Regulatory Affairs team. Title and salary commensurate with experience.

This position provides senior regulatory oversight for the review and approval of promotional materials and related external communications for products. Reporting to the Head, Regulatory Affairs Advertising and Promotion, the incumbent helps ensure materials are accurate, balanced, substantiated, consistent with Food and Drug Administration (FDA) approved labeling and compliant with applicable FDA regulations, guidance, industry standards and company policies. She/he supports compliant business execution by providing strategic regulatory advice, leading complex promotional reviews, managing FDA submission requirements and improving review processes.

The incumbent serves as secondary company contact to the FDA Office of Prescription Drug Promotion (OPDP) and helps ensure materials are submitted to the FDA in an accurate, compliant and timely manner to meet company goals.

Primary duties/responsibilities

- Reviews and approves advertising and promotional materials ensuring compliance with applicable FDA laws, regulations and guidance documents

- Provides strategic input and clear regulatory advice towards the development of compliant yet competitive advertising and promotional material

- Key resource for regulatory advice on promotional and advertising initiatives throughout the company

- Maintains continued awareness and understanding of new and existing FDA regulations, guidance documents and enforcement actions regarding advertising and promotion of pharmaceutical products and communicates these to PRC and senior management, as needed

- Provides training regarding FDA expectations on advertising and promotion, as requested

- Provides strategic input on regulatory requirements for claim substantiation for desired promotional claims to enhance marketability of product portfolio

- Prepares and approves Form FDA-2253 submissions to OPDP

- Contributes to, and drives, Advertising and Promotion regulatory process improvements in relevant areas, as needed

Requirements

Special knowledge or skills needed and/or licenses or certificates required

Associate Director - PhD or PharmD in life sciences, pharmacy, medicine or a related discipline and minimum 3 years’ experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry REQUIRED

-OR-

Bachelors degree in life sciences, pharmacy, medicine or a related discipline and minimum 7 years’ experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry REQUIRED

Director - PhD or PharmD in life sciences, pharmacy, medicine or a related discipline and minimum 4 years’ experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry REQUIRED

-OR-

Bachelors degree in life sciences, pharmacy, medicine or a related discipline and minimum 8 years’ experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry REQUIRED

FOR ALL LEVELS:

- In-depth knowledge of FDA regulations and their interpretation relevant to prescription drug advertising, promotion and labeling REQUIRED
- Direct experience interacting with FDA OPDP REQUIRED
- Ability to influence without direct authority REQUIRED

Work Arrangements: We are a HYBRID work environment requiring candidates to be able to work majority of week in our NJ office.

Anticipated salary range:

Associate Director - $160 to 180K/yr.

Director - $185 to $230K/yr.

Base salary offered is contingent on assessment of candidate’s education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-hybrid

Manager, U.S. Regional Regulatory Lead - LCM

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.

**Position Overview:**

Regulatory leaders who leverage regional regulatory experience to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision/strategies for assigned product/s with a patient-centric focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling and CMC GRAST members to ensure ‘One GRA Voice’, appropriate inputs into risk assessment and decision making. Ensures bi-directional communication with stationed region commercial operations and GRA. With support, engaging with health authority (HA) in stationed country (FDA or EMA), maintaining productive relationship with HA contacts and driving positive regulatory outcomes with respective HA for assigned product/s in conjunction with GRL. Contributes to product health authority interaction with support GRL or Regulatory TA Head. Partner with GRAST members to achieve regulatory deliverables (including leading assigned tasks) while fostering individual accountability, ‘team spirit’, actively contribute and executing on decisions expeditiously resulting in positive regulatory outcomes.

**\*\*\* This is a hybrid position based in Waltham, MA or King of Prussia, PA with a minimum of 3 days onsite in the designated work location weekly. Relocation and mobility assistance are not provided.**

**Key Responsibilities:**

- With support, accountable for assigned product relationship with a health authority (FDA or EMA), ensuring alignment with product GRL and as needed, support from Head, Regulatory TA if escalation is required. May negotiate on behalf of CSL with health authority to achieve desired regulatory outcome.
- Developing regional knowledge regarding health authority requirements, regulatory filing pathway/categories, processes, and ways of working and thus, can provide relevant guidance / assessment to internal stakeholders (e.g., GRAST, GRL & Commercial) on means to address project challenges, leverage regulatory opportunities and advise on risk for developmental, new, and marketed products.
- Under the product GRL, supports regional regulatory activities as assigned, inclusive of potential to contribute to core document preparation (e.g., core briefing book, pediatric plans, etc.), product filing preparation activities (investigational, new, and marketed) and health authority engagements. Responsible for Module 1 documentation required for submission and supports response to health authority comments activities with guidance from GRL.
- Actively contribute to the GRAST activities, strategy development, document reviews and competitive regulatory intelligence. Ensures on-time execution of regulatory activities at the regional level, achieving positive regulatory outcomes. Partners with GRL to develop internal communications and distributes GRAS communications to regional commercial stakeholders. Actively connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC.
- Proactively fosters and promotes effective relationships across Global Regulatory Strategy. Updates and maintains applicable regulatory systems (e.g., Veeva) to ensure tracking and compliance deliverables.
- Applies the CSL Leadership Capabilities – Build Bridges, Think Beyond, Unleash Outcomes, Ignite Agility, Inspire the Future and Cultivate Talent – to oneself.

**Minimum Qualifications:**

- Bachelor’s degree in Pharmacy, Biology, Chemistry, Pharmacology, Clinical Medicine, or related life science field. Advanced degree in a related field (MS, PhD, or MD, DVM) or MBA is preferred
- Minimum of 5+ years of regulatory/submission experience in the biotech or pharmaceutical industry
- 3+ years of experience working on developmental products
- Knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product development and approval in one or more key regions (EU, US, Japan)
- Experience working in Regulatory Affairs with agency interaction responsibility with at least one health authority is preferred.
- Relevant experience working in a complex and matrix environment.
- Ideal candidates will have clinical or device foundation
- Demonstrated ability to think strategically, assesses prudent risks and develop bold, agile, innovative approaches to complex challenges
- Proven effective verbal and written communication skills and ability to successfully work across all levels of the organization
- Foster productive, working relationships within CSL (e.g., R&D and Commercial).

The expected base salary range for this position at hiring is $129,000 - $153,000/yr. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the Waltham, MA USA work location at the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

\#LI-HYBRID

**About CSL Behring**

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit [https://www.csl.com/](<https://www.csl.com/>) and CSL Plasma at [https://www.cslplasma.com/](<https://www.cslplasma.com/>).

**Our Benefits**

For more information on CSL benefits visit [How CSL Supports Your Well-being | CSL](<https://www.cslbenefits.com/csl/candidates>).

**You Belong at CSL**

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

**Equal Opportunity Employer**

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit [https://www.csl.com/accessibility-statement](<https://www.csl.com/accessibility-statement>).

Senior Director, Immunology Translational & Clinical Research

CSL Behring is a global biopharmaceutical leader committed to developing innovative therapies for patients with rare and serious diseases. Our Immunology franchise is advancing a diverse pipeline targeting autoimmune and inflammatory conditions across rheumatology, neuroimmunology, and rare dermatology.

Could you be our next Senior Director, Immunology Translational & Clinical Research? The job is in our Waltham MA or Melbourne Australia Office. This is a hybrid position and is onsite three days a week. You will report to the Research Therapeutic Area Lead, Immunology/Transplant and Vaccines.

You will work hands-on as a clinical subject matter expert embedded with the research team, bringing a true bench-to-bedside mindset rather than a purely advisory role. Partnering day-to-day with the Research Therapeutic Area Lead and bench scientists, you will roll up your sleeves to prioritize therapeutic targets, shape clinical development plans, and directly translate mechanistic and preclinical data into first-in-class or best-in-class immunology therapies. You will be an active, present partner from early ideation through first-in-disease, working shoulder-to-shoulder with discovery research, translational medicine, clinical development, and business development to advance CSL Behring's immunology pipeline.

This is a high-impact role directly influencing portfolio prioritization, target assessment, and early clinical program design through active day-to-day collaboration, not just strategic oversight.

**RESPONSIBILITIES:**

Scientific Leadership & Disease Area Expertise

- Act as the hands-on clinical subject matter expert and internal champion for one or more immunology disease areas, with rheumatology expertise strongly preferred; neuroimmunology and/or dermatology also considered
- Bring a bench-to-bedside mindset, working directly with bench scientists to translate mechanistic understanding of immune pathology into actionable therapeutic hypotheses and target identification strategies
- Sit alongside the research team as an active partner in prioritizing therapeutic targets and building out clinical development plans, not just reviewing decisions after the fact
- Stay personally close to the competitive landscape, emerging science, and unmet medical need across assigned disease areas, digging into primary data and literature directly
- Represent CSL Behring at key scientific conferences, advisory boards, and KOL meetings; build and actively maintain a hands-on network of thought leaders, clinical investigators, and academic collaborators

**Pipeline Development & Asset Progression**

- Get directly involved end-to-end in asset progression from ideation through first-in-disease designation, personally working through scientific rationale, translational endpoints, patient population selection, and clinical strategy alongside the project team
- Lead or co-lead target and asset evaluation activities, personally reviewing preclinical and clinical data packages, mechanism-of-action assessments, and translational feasibility analyses line by line
- Partner with development colleagues on IND-enabling studies, proof-of-concept study designs, and Phase 1/1b protocol development, working directly with study teams
- Be the go-to immunology clinical subject matter expert embedded with discovery colleagues day-to-day, bridging preclinical science and clinical relevance to directly shape program design and go/no-go decisions
- Work hands-on with discovery and translational teams to define disease-relevant biomarkers, pharmacodynamic readouts, and patient stratification strategies for early clinical programs
- Actively contribute to R&D programs as a working subject matter expert, providing direct, in-the-weeds guidance on the clinical development pathway
- Partner closely and continuously with the Research Therapeutic Area Lead, RPLs, and Immunology core team members to prioritize therapeutic targets and personally help maintain a best-in-class immunology portfolio

Cross-Functional Collaboration & Strategic Input

- Partner directly with Business Development colleagues on in-licensing, and partnering opportunities within immunology, on clinical and scientific due diligence
- Contribute to drafting Target Product Profiles (TPPs), integrated development plans, and portfolio reviews in partnership with clinical, commercial, and research colleagues
- Provide disease area expertise to regulatory submissions, clinical study reports, and scientific communications

Qualifications

- MD or DO with clinical experience in rheumatology (preferred); neuroimmunology and/or dermatology also acceptable
- Demonstrated bench-to-bedside research mindset with hands-on, working-level experience translating preclinical and translational science into clinical strategy, not purely oversight experience
- Experience in drug development within a biotech, pharmaceutical, or academic environment
- Demonstrated hands-on experience in preclinical to first-in-disease (or equivalent early clinical milestone) programs in immunology
- Deep scientific expertise in the immunological mechanisms underpinning autoimmune and inflammatory diseases
- Established and active network in drug development with recognized relationships across rheumatology, neuroimmunology, and/or dermatology communities
- Proven track record of evaluation of preclinical and clinical assets, including direct target assessment, data package review, and go/no-go decision-making, plus active support of BD due diligence and TPP drafting
- Strong ability to synthesize complex scientific data and communicate strategy clearly to diverse audiences including senior leadership

The expected base salary range for this position at hiring is $338,000 - $390,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the time of this posting in MA. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

\#LI-HYBRID

**About CSL Behring**

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit [https://www.csl.com/](<https://www.csl.com/>) and CSL Plasma at [https://www.cslplasma.com/](<https://www.cslplasma.com/>).

**Our Benefits**

For more information on CSL benefits visit [How CSL Supports Your Well-being | CSL](<https://www.cslbenefits.com/csl/candidates>).

**You Belong at CSL**

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

**Equal Opportunity Employer**

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit [https://www.csl.com/accessibility-statement](<https://www.csl.com/accessibility-statement>).

Insmed Incorporated

Vice President, Biologics Research

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We’re looking for a Vice President, Biologics Research to provide scientific, strategic, and organizational leadership for biologics discovery, engineering, and early-stage development at Insmed. You’ll report to the Head of Insmed’s east coast Research and work closely with senior leaders across R&D and the broader organization.

You will help set the scientific vision for biologics research, ensure strong execution for discovery across multiple therapeutic modalities, and serve as a key partner to collaborating functions and stakeholders as we translate discovery science into clinical programs. You will combine deep expertise in protein engineering and immunology with hands-on experience advancing biotherapeutics from discovery into the clinic.

The Biologics Research organization includes a growing group of \>50 scientists and staff distributed across two research sites and comprising the following groups:

• 5+ large molecule discovery and engineering teams

• AAV viral vector engineering team

• AAV gene therapy discovery team

• Immunology team

• Computational biology and data science teams

• Research bioprocess development team

• In vivo model team

**What You'll Do:**

**Scientific Leadership and Strategy**

- Define and drive the long-term scientific strategy forbiologicsresearch, ensuringalignmentwith corporate and portfolioobjectives.
- Provide thought leadershipfortherapeutic targets,protein engineering,biologicsmodalityselection, andbiotherapeuticdiscovery, design, and development.
- Ensure scientific rigor, innovation, and data-driven decision-making across allbiologicsprograms.
- Supportexpansionoflaboratory automation and adoption of agentic AI-enabled workflows and decision-making.

**Drug Discovery and Preclinical Development**

- Ensureseamlessintegration of computational biology, data science, and experimental efforts.
- Oversee and supportteams through key milestones includingestablishing screening cascades, molecular design,candidate selection,preclinical development, andIND-enabling studies.

**Translation and Clinical Interface**

- Supportfirst-in-human readiness andprovide input intoclinical study design considerations.
- Partner withTechnical Operations,Clinical,Toxicology, DMPK, TranslationalBioanalytics, and Regulatory teams to support IND submissions and early clinical development.
- Provide scientific leadership in understanding human immune responses (CD8+, CD4+, and B cell responses) to protein antigens andthe impact onsafety, efficacy, and durability.

**People and Organizational Leadership**

- Recruit, lead, and develop a high-performingandcollaborativebiologicsresearch organization.
- Build strong scientific leadership at the director and senior director levels.
- Foster a culture of accountability, innovation, inclusion, and cross-functional collaboration.

**Cross-Functional and Executive Engagement**

- Serve as a key member of the R&D leadership team and a scientific advisor to senior executives.
- Representbiologicsresearch internally withcross-functionalstakeholdersandexternallywithcollaborators,partners,and other 3rdparties.

**Who You Are:**

You have aPhD or equivalent degreealong with15years of experience inbiopharma or biotech R&D, with progressive leadership responsibility.

Youare:

- a strategic thinker with strong scientific judgment and the ability to balance innovation with execution.

- an effective leader of multidisciplinary teams in a matrixed, fast-paced environment.

Youhave:

- expertise in protein engineering and knowledge of adaptive immunology.

- generalfamiliarity with modern protein design technologies (e.g., computational design, AI/ML-enabled approaches).

- experience with biotherapeutic drug development, including:

- in vivo pharmacology

- PK/PD strategy

- preclinicalCMC

- support fortoxicology and safety assessment

- support for first in human translation

- excellent communication skills, with the ability to influence at the executive level and translate complex science into clear decisions.

- a track record of successful cross-functional collaboration and delivery of high-impact programs.

**WhereYou’llWork**

This is an onsite position based out of our New Hampshire office, with flexibility for some remote work.

**Travel Requirements**

This role requires occasional travel (approximately 5%–15%)

\#LI-MC1

\#LI-ONSITE

**Pay Range:**

$290,000.00-396,000.00 Annual

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

New Hampshire

Associate Director, Regulatory Affairs, Post Approval

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

The Associate Director, Regulatory Affairs – Post-Approval is responsible for leading regulatory activities related to approved products in Japan and for leading Japanese specific regulatory operational activities. This position serves as the regulatory lead for post-approval compliance, ensuring products remain compliant with the Pharmaceuticals and Medical Devices Act (PMD Act) and other applicable Japanese regulations while supporting commercial and medical initiatives.

The role provides strategic regulatory guidance for review and approval of promotional and medical communications, leading maintenance of Japanese Package Insert and Japanese specific regulatory operational activities. The Associate Director partners closely with Medical Affairs, Pharmacovigilance, Quality, Commercial, Legal, and Global Regulatory Affairs.

This individual is expected to maintain strong relationships with Japanese health authorities, provide strategic regulatory leadership, and proactively identify regulatory risks and opportunities.

**What You'll Do:**

**Key Responsibilities (not necessarily be limited to, the followings)**

**Post-Approval Regulatory Strategy**

- Provide regulatory leadership for Japanese Package Insert maintenance as an owner of Japanese Package Insert in Japan (leading update of Japanese Package Insert for approved product in Japan and supporting Japanese Package Insert creation for (s)NDA) in collaboration with Global RA Labeling
- Provide regulatory leadership for management of manufacturing and marketing authorization licenses
- Lead for handling information disclosure requests
- Lead/support other post-approval regulatory activities
- Ensure compliance with Japanese post-approval regulatory requirements.
- Interpret evolving Japanese regulations and assess their impact on existing products and business operations.
- Serve as the regulatory subject matter expert for post-approval compliance within Japan.
- Serve as the Regulatory Affairs reviewer for promotional, scientific, and medical communication materials intended for use in Japan to ensure compliance with PMD Act, and JPMA Promotion as well as other applicable advertising regulations.
- Provide regulatory guidance to Commercial and Medical Affairs teams during material development.
- Partner with Legal and Compliance to resolve complex promotional issues
- Monitor emerging PMDA, MHLW, and JPMA regulations, guidance, and industry trends.
- Support for Three Officers’ activity

**Who You Are:**

**Life at Insmed**

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, age, or any other characteristic protected by law.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Associate Director, Regulatory CMC

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

This position is a key role that will provide CMC regulatory strategy to achieve regulatory submissions and approvals in Japan. As a strategic function, CMC RA is required to collaborate closely with multiple functions within Insmed and with external CMOs. A successful candidate will provide knowledge, understanding, interpretation, and utilization of regulatory guidance and regulations, as well as industry and government agency best practices and trends in Japan.

**What You'll Do:**

- Plan, execute and manage regulatory submissions for compounds in various phases of clinicaldevelopment, marketing applications, and post-approval lifecycle activities in Japan by working with globalregulatory affair CMC team.
- Provide regulatory strategies and identify the gaps and challenges of CMC development to ensure theapprovability of the drug products in Japan with the flexibility for post-approval maintenance and lifecyclemanagement of the marketed products.
- Develop plans for the preparation of CMC meetings with the regulatory agencies in Japan, and draft andreview regulatory documents for CMC meetings with the agency.
- Provide interpretation of applicable PMDA and global regulations (ICH, WHO, ISO, etc.) to ensure CMCcompliance within Insmed. Keep abreast of all pertinent regulations and guidance documents for pre andpost approval submissions. As needed, communicate PMDA regulatory CMC requirements to teammembers and advise of implications for necessary changes in planned CMC approaches.
- Contribute to scientific discussions and collaborations with scientists to resolve technical and regulatoryissues in drug substance synthesis, management of impurities and degradation products, formulation anddevice combination product development at various development stages and product lifecycles.
- Communicate and negotiate with regulatory authorities in Japan as necessary, directly and indirectly.

**Who You Are:**

- Minimum three (3) years pharmaceutical Regulatory CMC experience in multinational companies, includingexperience as an RA CMC product lead, or equivalent industry experience.
- A solid understanding of PMDA regulations for drugs/biologics with the ability to identify the difference inregulations across the regions. Proven ability to liaise with PMDA as lead in agency interactions and productdevelopment meetings.
- Understanding of scientific principles and regulatory CMC requirements relevant to global drug developmentand post-market lifecycle support.
- Able to deal with issues of critical importance, provide regulatory strategy/advice and make reasoneddecisions on CMC regulatory issues for which they may not be clear or with specific regulatory guidance.
- Ability to wort together with internal and external teams towards achieving goals that support Insmed’s keystrategic objectives.
- Demonstrated experience improving, developing, and implementing new processes.
- Good communication skills with the ability to effectively present ideas and influence others that achievedesired results (verbal and written fluently in Japanese and English).
- Flexible, diplomatic and able to effectively deal with ambiguity.
- Highly organized with strong attention to detail, clarity, accuracy, and conciseness.
- An uncompromising ethical standard and level of conduct are essential.
- Bachelor's or Master’s level degree in pharmacy, nursing, or other healthcare-related profession or lifesciences required.

**Where You’ll Work**

This role is based out of our Tokyo office with weekly flexibility to support both your professional and personal needs.

**Travel Requirements**

This role requires occasional domestic and international travel approximately 10%.

**Life at Insmed**

インスメッド日本オフィスは、国会議事堂を望む東京の中心部、溜池山王駅直結の好立地に位置しています。最新のワークスタイルに対応したフリーアドレス制を導入し、開放的で柔軟な働き方を実現しています。カフェエリアでは部門を超えた自由なコミュニケーションやコラボレーションを促進する空間を創り出しています。

日本法人の拠点として、患者さんにより良い医療をお届けするため、社員一同が一丸となって日々邁進しています。

社員一人一人の充実した働き方を実現するためのサポート：

• ワークライフバランスの実現

フレキシブルな勤務時間や充実した休暇制度

• 魅力的な報酬制度

退職金制度、株式報酬制度、従業員持株制度（ESPP）への参加機会

• キャリア開発支援

社内研修、外部研修プログラムの活用、LinkedIn Learning、業務に特化した専門研修

• 先進的な学習支援

AI搭載の学習ツール、社内リソースへのアクセスを支援するデジタルアシスタント

• グローバルの表彰制度や従業員リソースグループ活動

• ハイブリッドワーク環境の整備

場所や時差を超えたシームレスな協働を実現する最新テクノロジー、充実したIT支援体制

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, age, or any other characteristic protected by law.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Senior Research Associate, Biology

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We’re looking for a Senior Research Associate on the Research Development Laboratory team to help us expand what’s possible for patients with serious diseases. Reporting to the Scientist, you’ll support discovery and development campaigns focused on next-generation biotherapies for serious unmet medical needs.

**What You'll Do:**

In this role, you’ll have the opportunity to work within a multidisciplinary team, conducting molecular biology and protein engineering on a diverse array of biological drug candidates. You’ll also:

- Design, execute and optimize molecular biology experiments to support lead candidate selection
- Validate and perform DNA based assays (DNA purification, PCR, and Quality and Quantification of DNA)
- Culture mammalian cell lines and conduct transient transfections of mammalian cells for protein expression
- Culture bacterial cell lines and conduct protein expression and purification
- Interact and collaborate with multidisciplinary team to advance the project
- Maintain accurate, detailed, and timely records

**Who You Are:**

You have a Master’s degree in Molecular Biology or related field or a Bachelor’s degree in Molecular Biology or related field with minimum 2 years of experience.

You are or you also have:

- Requires hands-on experience with routine molecular biology methods including plasmid cloning, PCR, and DNA isolation and protein expression
- Organizational skills and ability to prioritize multiple tasks

**Nice to have (but not required):**

- Hands-on experience with tissue culture, protein purification, enzyme assay, gel electrophoresis, and flow cytometry are strongly preferred
- Proficiency with SNAPgene, GraphPad Prism/Excel, and relevant scientific software is desirable
- Experience with library preparation for NGS, DNA and RNA quality and quantification methods (TapeStation and Qubit) is desirable but not required
- Experience with protein binding kinetics assays (BLI, SPR, and ELISA) is desirable but not required

**Where You’ll Work**

This role is based out of our  **_New Hampshire Research Development Laboratory_**  and requires  **_full-time, in-person presence_**  to support hands-on collaboration, access specialized equipment, and/or operational needs.

\#LI-ONSITE

\#LI-BA

**Travel Requirements**

Minimal travel expected

**Pay Range:**

$80,000.00-102,000.00 Annual

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Senior Director, Regulatory Affairs - Early Development/Business Development

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We’re looking for a Senior Director, Regulatory Affairs – Early Development/ Business Development on the Regulatory Affairs team to help us expand what’s possible for patients with serious diseases. Reporting to the Senior Vice President, Regulatory Affairs, you’ll provide strategic and operational regulatory leadership to support both early-stage drug development and business development programs. Responsibilities will include strategic evaluation of regulatory risks and opportunities for external assets, assessing likelihood of technical and regulatory success, and contributing to the development and execution of global regulatory strategies for internal pipeline programs. You will work cross-functionally to enable informed investment decisions and contribute to the efficient advancement of development programs by developing the regulatory strategy for selected drug candidates. You will provide regulatory input to global cross-functional project teams throughout the phases of product development and related submission activities and will serve as the global or regional regulatory lead on the projects. You will act as the primary regulatory contact for the US FDA.

**What You'll Do:**

In this role, you’ll have the opportunity to develop and lead the regulatory strategy for early development programs. Additionally, you will represent the regulatory affairs department on due diligence assessments for external assets, including evaluation of regulatory pathways, data packages, risks, and mitigation strategies. You’ll also:

- Critically assess completeness and adequacy of nonclinical, clinical, and CMC data packages, identifying key gaps, risks, and value inflection points
- Provide clear regulatory recommendations to support early development/business development decisions and participate in senior leadership discussions
- Contribute to cross-functional diligence teams, integrating regulatory perspectives into overall asset valuation and development planning
- Contribute to preparation and submission of regulatory documents (e.g., pre-IND meeting requests, briefing books, INDs, amendments)
- Support health authority interactions, including meeting strategy, briefing materials, and response development
- Provide regulatory input into study design, endpoints, and overall development plans and ensure alignment of regulatory strategy with clinical, nonclinical, and CMC plans
- Partner cross-functionally with Clinical, CMC, Nonclinical, Biostatistics, and Program Management teams
- Monitor evolving regulatory landscape and apply relevant guidance and precedents and identify regulatory risks proactively and propose practical mitigation strategies
- Ensure high-quality and timely delivery of regulatory contributions across programs

**Who You Are:**

You have an advanced degree (PhD, PharmD, MS) along with 10+ years of experience in Regulatory Affairs or related functions, with hands-on experience in regulatory submissions across multiple regions (U.S., EU, and/or other international markets). You also have:

- Experience supporting early-stage drug development (pre-IND through Phase 2)
- Demonstrated experience contributing to regulatory submissions and health authority interactions (e.g., pre-IND, Type B meetings)
- Strong understanding of global regulatory frameworks
- Deep understanding of the drug development process
- Ability to critically assess scientific, clinical, and CMC data in a regulatory context
- Strong communication, strategic thinking, and cross-functional collaboration skills
- Ability to manage multiple priorities in a fast-paced environment
- Highly organized with strong attention to detail, accuracy, clarity, and conciseness
- Ability to manage tight deadlines; must be efficient, detail-oriented, adaptable, and a self-starter

**Nice to have (but not required):**

- Experience in regulatory due diligence, business development, or asset evaluation preferred
- Strong understanding of global regulatory frameworks (FDA, EMA; PMDA a plus)

**Where You’ll Work**

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected.

**Travel Requirements**

This role requires occasional domestic/international/global travel (approximately 20%)

\#LI-REMOTE

\#LI- JK

**Pay Range:**

$222,000.00-303,000.00 Annual

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Nationwide

Summer Intern – Global Healthcare Compliance

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We’re looking for a Summer Intern – Global Healthcare Compliance on the Compliance Team to help us expand what’s possible for patients with serious diseases.

The Insmed Summer Internship Program is designed to give you more than just a glimpse into the pharmaceutical industry—it’s a chance to make a real impact. Over the course of the summer, you’ll gain hands-on experience, contribute to meaningful team projects, and learn directly from skilled professionals who are invested in your growth.

Our 2027 Summer Intern program is a full-time (40 hours per week), 12-week, paid internship. The internship may present opportunities for rotational assignments within the function, and the intern will be assigned goals and objectives that will support the strategic business plan of the company.

**What You'll Do:**

In this role, you'll have the opportunity to help build a next-generation healthcare compliance program. You will help implement AI tools and agents that strengthen Insmed's compliance program and culture.

You’ll also:

- Design and develop AI tools and AI agents that support healthcare compliance operations, including use cases related to HCP interactions, monitoring, and compliance effectiveness.
- Contribute to Voice Our Values, Insmed's Speak Up culture program, by building attention-grabbing resources that reinforce ethical conduct and raising issues.
- Assist with compliance monitoring and record reviews, identifying opportunities to improve our processes and mitigate healthcare compliance risk.
- Build foundational knowledge of key healthcare compliance requirements, including OIG 7 Elements of an Effective Compliance Program, DOJ Evaluation of Corporate Compliance Programs, PhRMA Code on Interactions with HCPs, and applicable laws including Anti-Kickback Statute, False Claims Act, FCPA, Physician Payment Sunshine Act, etc.
- Support special projects across the Global Compliance department, including developing compliance trainings, policies/SOPs, and other relevant projects.
- Collaborate with Insmed stakeholders across departments and geographies (e.g., Marketing, Sales, Market Access, Medical Affairs, Patient Support, Japan, Europe, etc.) on compliance-related initiatives.
- Present a capstone project to senior compliance leadership demonstrating risk analysis, strategic thinking, business alignment, and communication skills

**Who You Are:**

You are a current student working on a Bachelor's, Master's, or Doctorate degree (including JD, JD dual degree, or PhD) with an interest in compliance, law, technology, data science, or a related field in the pharmaceutical or healthcare industry.

You are or you have:

- Strong willingness to learn, with eagerness to expand knowledge of healthcare compliance and AI.
- Familiarity with healthcare compliance regulations such as the False Claims Act, Anti-Kickback Statute, PhRMA Code, or Sunshine Act.
- Demonstrated interest or experience in artificial intelligence, whether through coursework, projects, or extracurricular activities.
- Effective communication skills (verbal and written) and highly organized with strong attention to detail, clarity, accuracy, and conciseness.
- Commitment to Insmed's five corporate values: collaboration, accountability, passion, integrity, and respect.

**Nice to have (but not required):**

- Coursework or experience in data governance, AI ethics, or responsible AI frameworks.
- Prior internship or project experience in legal, healthcare compliance, life sciences, or a regulated industry.
- Experience building AI agents, workflows, or applications via low-code/no-code AI tools, Python, or other programming or automation platforms, e.g., Claude Cowork, Lovable, Notebook LLM, etc.

**Where You’ll Work**

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events may be expected.

**Pay Range:**

$20.00-35.00 Hourly

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. Our internship program reflects that commitment by supporting how you learn, grow, and show up each day while contributing to work that matters.

Our internship offerings include:

- Paid company holidays
- Hands-on learning in real-world projects
- Networking opportunities with leaders and social events with your peers
- Mentorship and professional development
- A final presentation to celebrate your contributions
- Access to office amenities for those who are not remote

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

[*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Director, Bioprocess Development (Biologics Research)

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We’re looking for a Director, Bioprocess Development on the Biologics Research team to help us expand what’s possible for patients with serious diseases. Reporting to the Senior Director, Biologics Research, you’ll lead the design, buildout, and execution of upstream and downstream capabilities within our Biologics Research organization.

**What You'll Do:**

In this role, you’ll have the opportunity to \<play a critical role in establishing a high-performing team and state-of-the-art laboratories to support a diverse pipeline of biotherapeutic programs from early discovery through preclinical CMC. You’ll also:

**Team Leadership & Organizational Build**

- Build, lead, and mentor a high-performing research bioprocess development team
- Establish a collaborative, accountable, and scientifically rigorous team culture
- Set priorities and allocate resources across multiple concurrent programs

**Laboratory & Capability Development**

- Design and oversee the buildout of new state-of-the-art research bioprocess development laboratories
- Define equipment strategy and select platforms for upstream processing (USP): microbial and mammalian expression systems, as well as downstream processing (DSP): purification workflows including chromatography and filtration
- Implement scalable, fit-for-purpose technologies aligned with early-stage and preclinical needs

**Technical Leadership (Upstream & Downstream)**

- Provide subject matter expertise in recombinant protein expression in bacterial and mammalian systems, cell culture process development, media optimization, scale-up strategies, and protein purification processes including flocculation, tangential flow and depth filtration, buffer exchange, and affinity, ion exchange, and mixed mode chromatography
- Drive development of robust, reproducible processes suitable for preclinical material generation
- Establish platform approaches and best practices for rapid program advancement

**Hands-On Execution**

- Contribute directly to experimental design, experimentation, troubleshooting, and data interpretation
- Lead or support critical experiments, especially during early lab setup and high-priority programs
- Develop and review protocols, reports, and technical documentation

**Program Support & Cross-Functional Collaboration**

- Partner closely with Discovery, Analytical, Technical Operations, and Preclinical Development teams
- Support multiple biologics programs across modalities (e.g., enzymes, antibodies, fusion proteins)
- Ensure alignment of bioprocess strategies with program timelines and CMC expectations
- Provide input into candidate selection based on developability and manufacturability

**CMC & Preclinical Development Interface**

- Establish processes and documentation to support transition into formal CMC development
- Collaborate with external partners or internal CMC teams for tech transfer and scale-up

Ensure early processes are designed with downstream manufacturability in mind

**Who You Are:**

You have a PhD in chemical engineering, biochemical engineering, biology, or related field with 5+ years of industry experience, or M.S. with 8+ years of industry experience. You are or you also have:

- Demonstrated experience in biologics process development within biotech or pharmaceutical settings.
- Deep experience in both upstream and downstream bioprocess development.
- Expertise in early- to late-stage preclinical CMC for biotherapeutic development candidates.
- Hands-on experience with microbial expression systems (specific expertise with *E. coli*), mammalian expression systems, optimization of bioreactor operations (bench-scale; scale-up knowledge preferred), optimization of protein purification and characterization workflows (with knowledge of scalable processes), and construction and optimization of commercial expression strains (both microbial and mammalian)
- Successful track record of tech transfer to technical operations groups and/or CDMOs.
- A builder’s mindset with the ability to create structure while maintaining agility and willingness to be hands-on while operating at a strategic level.
- Passion for developing people and advancing innovative biologics programs.
- Proven track record of building and leading teams and/or functional groups.
- Strong leadership and mentoring skills
- Experience managing multiple programs in a fast-paced, research-driven environment
- Excellent communication and cross-functional collaboration abilities

**Nice to have (but not required):**

- Experience building laboratories and selecting capital equipment
- Exposure to early GMP considerations
- Familiarity with a range of biologic modalities (e.g., enzymes, mAbs, bispecifics, engineered proteins, half-life extension technologies)

**Where You’ll Work**

This role is based out of our Lebanon, NH office and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs.

**Travel Requirements**

Minimal travel expected

\#LI-BA

\#LI-ONSITE

**Pay Range:**

$185,000.00-252,500.00 Annual

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Director, Brand Counsel

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We are seeking a Director, Brand Counsel to serve as primary legal counsel supporting one of Insmed’s marketed respiratory products. Brand Counsel will provide strategic and tactical legal advice for the brand and serve as legal reviewer of all promotional, non-promotional, and scientific materials and activities initiated in furtherance of the brand. This role will function as a key strategic partner with the brand team and will work closely with other members of the legal team and cross-functional partners, such as commercial, medical affairs, corporate communications, market access, patient advocacy, and compliance.

**What You'll Do:**

In this role, you will serve as the primary legal advisor and strategic partner to the brand team of a marketed respiratory product. You will provide strategic and tactical legal support in furtherance of the brand plan. You will report to the Executive Director, Corporate Counsel and partner closely with peers on the Legal team in support of the Respiratory Therapeutic Area.

You will have responsibility for:

- Serve as a trusted legal advisor and strategic partner to business leaders on the brand team.
- Provide proactive legal advice to business partners and drive legal strategy through the review of brand team initiatives in support of execution of brand plan for one of Insmed’s marketed respiratory products in accordance with current FDA and FTC regulations, guidance, and enforcement activities with a focus on anti-kickback, false claims act, and advertising and promotional regulations, and counsel on risk mitigation strategies, as needed.
- Establish rapport and constructive working relationships with commercial, medical, and other cross-functional leaders and team members at all levels, encouraging proactive engagement with in-house legal counsel and operating as an active member of the legal and brand teams.
- Review promotional, non-promotional, and scientific materials and associated strategies and tactics for compliance with applicable guidance, laws and regulations and serve as primary legal member on the applicable review committees (e.g., Commercial Review Committee, Medical Review Committee).
- Review and provide legal advice on corporate communication and product communications and related internal and external activities and materials.
- Serve as contract review escalation point for related commercial, medical affairs, corporate communications contracts ensuring alignment with company standards and compliance with applicable laws and industry standards.
- Identify, communicate, and provide updates to business partners and the legal team on risks associated with day-to-day operational business activities and on current federal and state legal, regulatory, and enforcement developments related to the life sciences industry, including training clients on applicable legal issues within your expertise.
- Monitor and provide updates to business partners and legal team on current federal and state legal and regulatory risks and enforcement activities related to the life sciences industry.
- Partner with the business to proactively apply legal and regulatory guidance to brand tactics and strategy by understanding business goals and developing and implementing solutions to assist in the achievement of successful outcomes consistent with business objectives.
- Coordinate legal matters handled by outside counsel

**Who You Are:**

You have a JD degree from an accredited law school and valid license in New Jersey (or eligibility for limited in-house license) and a minimum of 5+ years related in-house legal experience representing life sciences companies.

In-house, public company experience preferred.

Additionally you have:

- Experience in promotional and non-promotional review, regulatory matters, risk management and contract management.
- Experience in contract, business, FDA, FTC, and laws and regulations specific to the life science industry.
- Excellent professional judgment and discretion and high standard of professional and ethical conduct.
- Ability to identify, strategize and respond to a broad range of issues related to business, operations and risk management.
- Ability to analyze, interpret, and apply government regulations, guidelines, and requirements.
- Ability to proactively identify problems, strategize across a broad range of business, operations, and risk-management issues, and implement effective solutions.
- Ability to exercise good judgment regarding the interpretation of policies, development of procedures, and selection of appropriate courses of action.
- Self-starter with strong drive for results and strong sense of ownership, but also willing to take direction.
- Ability to foster open communication, share subject matter expertise, and collaborate to reach a resolutions that meet organizational and business objectives and address identified legal, regulatory, and compliance risks.

**Travel Requirements**

This role requires occasional domestic travel of 10-20%.

**Where You’ll Work**

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events may be expected.

\#LI-SK1

\#LI-SK - Remote

**Pay Range:**

$205,000.00-280,000.00 Annual

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*