Manufacturing & Production

AbbVie

Senior Medical Director, Immunology, Global Patient Safety

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

\***This hybrid role could be based at any of AbbVie's location in the US such as North Chicago, IL Cambridge, MA, Worcester, MA, Irvine, CA, San Francisco, CA or Florham, NJ**

The Indication Product Safety Team (PST) lead for immunology products, under the direction of the Asset PST Lead will be actively and closely collaborating with the development medical lead, setting the safety strategy for a product in a development or approved indication. Indication PST lead will be responsible to one or more indications and will support safety through the product lifecycle (e.g. surveillance, signal detection, validation and assessment, risks assessment and mitigations strategies, etc…) together with the other members of the safety team (safety scientists, safety architects, and other cross functional colleagues). The PST lead will also closely collaborate with statistical science, epidemiology, regulatory and clinical development leads as well as medical affairs colleagues to support the asset strategy in the given indication with patient safety expertise.

Indication PST lead will be interpreting regulations related to pharmacovigilance supporting all patient safety activities, and will be leading the safety components of pre-NDA and NDA/sNDA submissions, regulatory responses, label and label updates, RMPs, PSURs, and IB updates.

**Responsibilities:**

- Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams, executive leadership and externally, as needed
- Lead and set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans, NDA/sNDA submission – safety component
- Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
- Understanding of the relevant to the patient safety evaluations pharmacology, and non-clinical toxicology data
- Effectively write, review and provide input on technical documents independently
- Oversight and responsibility for leading the strategy for periodic reports (DSURs, PSURs, PADERs etc.)
- Strong team player, able to adapt and work in a fast-paced environment
- Responsible for safety surveillance for pharmaceutical / biological / drug –device combined products
- Responsible for implementing risk management strategies for assigned products
- Proactively engaging, inspiring, coaching and mentoring team and colleagues
- Opportunities to co-author publications and participate in initiatives to continue developing and growing as a safety leader
- Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Qualifications

- MD / DO with 2+ years of patient management experience required
- 5+ years of patient safety experience in the pharmaceutical industry, including relevant leadership experience
- Prior involvement in marketing authorization application submissions or other relevant regulatory interactions
- Prior experience in pharmaceuticals’ clinical development
- Immunology/Internal medicine experience is strongly preferred
- Effectively analyze and guide analysis of clinical data and epidemiological information
- Effectively present recommendations / opinions in group environment both internally and externally
- Write, review and provide input on technical documents
- Work collaboratively and lead cross-functional teams
- Ability to lead cross-functional teams in a collaborative environment

Additional Information

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

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

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

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

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

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

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

Illinois

Director – Process Engineering / Senior Principal Research Scientist

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

Are you a passionate engineer who thrives at the intersection of science, innovation, and impact? AbbVie's Research and Development Process Engineering team is on the front lines of transforming cutting-edge science into life-changing medicines — and we're looking for a **Senior Principal Research Scientist or Director, Process Engineering** to help us push the boundaries of what's possible in drug product development. This position is being posted at two potential levels — Principal Research Scientist I and Associate Director — and we welcome candidates who feel they are a strong fit for either level to apply. Join us at our North Chicago, IL hub and be part of something bigger.

This isn't just a role — it's an opportunity to shape the future of drug manufacturing. Whether you join as a Sr Principal Research Scientist or step in at the Director level, you'll bring your proven project leadership in drug product development to drive synthetic molecule candidates from concept to commercial-ready processes, making real decisions that accelerate medicines to patients who need them most. At the Associate Director level, this role also carries broader accountability for setting technical strategy and may include direct people leadership responsibilities across the Process Engineering function.

You'll be a master of drug product manufacturing platforms — direct compression, wet & dry granulation, hot melt extrusion, tableting, encapsulation, and film coating — and you'll apply your deep understanding of powder material properties to unlock new levels of manufacturability and product performance. When challenges arise, you're the person who steps up to troubleshoot complex process and material issues with creativity and rigor. And when it's time to go big, you'll translate bench-scale breakthroughs into pilot plant realities through expert scale-up execution.

At AbbVie, we celebrate bold ideas, encourage experimentation, and give talented engineers and leaders the resources and autonomy to actually innovate. If you're ready to raise the bar, lead with influence, and leave your mark on some of the world's most important medicines — at either an individual-contributor or people/technical leadership level — we want to hear from you.

**Key responsibilities include:**

- Lead drug product manufacturing process early phase development for synthetic molecule development candidates within the AbbVie pipeline.
- Collaborate with development CMC teams to ensure manufacturing processes are aligned with intended commercial manufacturing sites.
- Advance scientific expertise within the function — mentoring peers and influencing senior leadership with your expert insights; at the Associate Director level, this includes providing technical leadership and, where applicable, direct oversight/management of team members.
- Drive the development of technologies and scientific innovations that expand AbbVie's small molecule formulation capabilities.
- Partner cross-functionally to build strategies that directly power AbbVie's drug discovery and development programs; at the Associate Director level, help shape department- and function-level strategy in partnership with senior leadership.
- Champion compliance with AbbVie's safety, quality, and regulatory standards.

Qualifications

- Bachelor’s Degree in Science related field with 18 years of related work; Master’s Degree Science or PharmD with 16 years of related work; PhD in Science or related field with 10 years of related work experience.
- Proven ability to innovate with a history of new or improved product releases.
- Interacts well with diverse groups within function and maintains strong working relationships with internal and external collaborators.

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 Director, Strategic Planning and Operations, Oncology Clinical Development

Company Description

**About AbbVie**

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

Job Description

**Purpose**

To enable AbbVie’s emergence as a World Class R&D organization, the Senior Director, Project Management, plays a leadership role with the Development TA Vice President (TA VP) and the Therapeutic Executive Committee (TEC) to optimize the value of our portfolio of current and future assets. Under the guidance of the TA VP, the incumbent is responsible for leading development of the long-term strategy (portfolio plan) for the TA; for supporting existing Asset Development Teams (ADTs) in effective utilization of the Asset Playbook discipline to better enable teams to maximize the value of the asset. Achieving these goals requires a combination of excellent interpersonal and collaborative skills, broad strategic thinking, and an ability to synthesize inputs and drive alignment in complex situations.

**Responsibilities**

- Serves as a core member of the TEC as a strategic partner with TA VP and TEC members, with responsibility for the TEC agenda and areas of focus, driving the overall, long-term TA strategy.
- Advises ADTs across the lifecycle, to ensure application of the Playbook and alignment of the Target Product Profile (TPP) and Development Plan with the TA strategy.
- Partners with Business Development as Co-lead of Therapy Assessment Teams, and works with Ventures & Early Stage Collaborations to undertake external molecule assessments consistent with TA strategy.
- Provides strategic input into the development of Disease Opportunity Profiles (DOPs), cross-functional evaluations of potential Discovery initiatives, and the TA investment thesis.
- Coordinates the generation of competitive environment assessments for review at TEC, to turn the data into useful working knowledge for the TEC and disease area in support of the pipeline.
- As appropriate, facilitates identification, evaluation, and implementation of novel tools and technologies (e.g., biomarkers, drug delivery systems, devices and other platform technologies, compliance tools, disease monitoring techniques) that can be employed to improve or accelerate pipeline progression in disease areas of interest.
- In collaboration with relevant functions, drives internal and external stakeholder assessments in order to anticipate changes in the external environment (e.g. regulatory trends, changing payer environment), and to understand the patient journey and levers to improve outcomes.
- Coordinates the conduct and rollup of long-range strategic planning and portfolio documentation for the TA, working in close collaboration with the Clinical TA VP, Decision Support Group (DSG), Commercial and R&D.
- Works with TA and TEC leaders to identify, prioritize, and nurture external collaborations (consortia, academic and scientific collaborations, key scientific leader advisors, etc.) in areas where we want to further our understanding of disease pathways and mechanisms. Advances our partnerships and alliances for improved outcomes, creating holistic “Total Patient Solutions”.

Qualifications

- Bachelors or equivalent degree required. Advanced degree (PharmD, PhD, MD, MBA) highly preferred.
- Minimum of 10 years (15+ years preferred) of research/development, commercial, project management, portfolio management, business development, or related experience in the pharmaceutical or biotech industry with a track record of expertise in one or more therapeutic areas.
- Recognized team player with proven facilitative leadership skills in a cross-functional global team environment. Proven performance in a matrix environment with ability to influence and align stakeholders.
- Excellent interpersonal skills. Ability to interact externally and internally to support business strategy.
- Strong analytical skills. Recognized ability to evaluate complex issues from multiple perspectives to ensure that balanced risk assessments are made.
- Excellent oral and written communication skills.

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>)

Future Opportunities, Join our Talent Community for Senior Scientist I, R&D Process Engineering

Job Description

Process Engineering, a part of AbbVie R&D’s Development Sciences organization, is responsible for designing and developing scalable processes to make drug substances and drug products, including small molecules, peptides, and antibody drug conjugates (ADCs), throughout pre-clinical and clinical development stages. Process Engineering also partners with Biologics CMC (Chemistry, Manufacturing, and Controls) Development and Aesthetics R&D functions to provide active engineering support to enable robust process scale-up and manufacturing of biologics drug substances and drug products including toxins and cosmetic active ingredients (CAIs). We contribute to the development of innovative engineering technologies and create valuable intellectual property through the composition of matter, chemical processes, and technologies resulting in cost-effective commercial manufacturing processes. We support the development of the supply chain for pipeline molecules and help prepare and defend CMC regulatory content.

Chemical/Bio Engineers within R&D Process Engineering support pipeline projects through all phases of development. Early in development, engineers focus on establishing an enabling process that can be scaled up successfully. In the later stages of development, engineers optimize the drug substance and drug product processes and lead manufacturing campaigns. Engineers also work cross-functionally to transfer the optimized process to manufacturing sites, develop control strategy, and prepare reports to support regulatory filings.

**Role Overview**

The successful engineering candidate will play a key role in the R&D Process Engineering function. The core deliverable of R&D Process Engineering is to develop robust manufacturing processes and advance innovative technologies using strong engineering fundamentals. The ideal candidate will have a passion for hands-on laboratory process development. The candidate is also expected to lead the identification and development of novel approaches and technologies to enhance process development efficiency and commercialization. The candidate must exhibit a collaborative nature in identifying process challenges on a wide range of projects and take part in a cross-functional team to deliver specific project needs.

**Key Responsibilities:**

- Develop robust manufacturing processes, supporting assets through all phases of development.
- Participate in development and characterization of new assets.
- Establish, communicate, and execute research plans.
- Develop commercial ready manufacturing processes in the laboratory and demonstrate the processes in the pilot plant.
- Address challenging problems with reactions, separations, and/or isolations using expertise in reaction kinetics, transport phenomena, and mathematical modeling.
- Author and/or review technical documents summarizing process development efforts and contribute to regulatory filings.
- Exhibit a collaborative nature in identifying process challenges on a wide range of projects and communicate findings and recommendations effectively by multi-disciplinary interactions with organic chemists, analytical chemists, process development engineers, pilot plant engineers, drug product development scientists, program managers, and regulatory affairs specialists.
- Author publications and present at scientific conferences.

Qualifications

- BS, MS, or PhD in Chemical/Bio Engineering or a related field and 10+ (BS), 8+ (MS), or 0+ (PhD) years of relevant industrial experience.
- Job level will be commensurate with academic and/or industrial work experience.
- Candidates are expected to have a strong background in chemical engineering and the proven ability to demonstrate their skills in this field.
- The candidate is expected to demonstrate the ability to solve difficult technical problems and champion new technologies to achieve project goals.
- The candidate is required to be a strong team player and possess effective oral and written communication skills.

**Preferred:**

- Working knowledge of analytical techniques such as UV/Vis, HPLC, FTIR, Raman, mass spectrometry, and microscopy.
- Experience with laboratory experimentation and process scale-up.
- Experience with mechanistic and/or process modeling or computational fluid dynamics.
- Experience with design of experiments and statistical tools.
- Familiarity with operation of chemical/biochemical process equipment and systems.
- Experience with control strategy development, risk assessments, and tech transfer.
- Experience with GxP compliance.

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>)

Post-Doc – Innovative manufacturing concepts on Biologics (all genders) (full-time, temporary for

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 job that makes possibilities real in patients' lives. And yours.**

**The job that helps you get ahead in life. Moving mountains together.**

Welcome to AbbVie! As part of an international company with 48,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity of addressing some of tomorrow’s 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 for developing and increasing your own skills? You’ve come to the right place!

Moving mountains together – as **Post-Doc – Innovative manufacturing concepts on Biologics (all genders)**

Early Manufacturing Process Development (EMPD) within Biologics Drug Product Development is responsible for developing robust manufacturing processes for AbbVie's parenteral pipeline projects, supporting the advancement of biologics through early clinical stages. Biologics are often co-administered with other biologics to boost their clinical efficacy and the overall patient experience, while requiring multiple injections. Formulating both active ingredients into a single drug product significantly strengthens patient compliance and dose accuracy. This goes along with additional technical challenges for drug development and manufacturing, which will become your primary topics of interest through the upcoming 24 months. You will design, execute and assess studies to identify key risks and their mechanisms for co-formulating biologics during drug product development and manufacturing, comprising identified unit operations as well as in-process controls to enable a state-of-the-art, compliant and robust control strategy while maintaining maximum dose-range flexibility.

**Responsibilities**

- Plan and perform systematic studies to dive deeper into innovative formulation concepts for biologic drug products
- Publish results in peer-reviewed journals and present work at internal panels and scientific conferences aligned with business objectives
- Collaborate with international multidisciplinary teams to advance project goals
- Participate in investigations on root cause analyses of development projects related to the scientific area
- Demonstrate a high degree of responsibility in maintaining scientific standards, and safe laboratory practices
- Maintain a high level of productivity in the laboratory setting
- Actively engage with scientific literature and apply insights to individual project(s) as well as the overall program

Qualifications

- Ph.D. in pharmaceutical technology, biochemistry or related area, preferably with a background in parenteral/biological processing or similar.
- Work experience in the field of protein aggregation is advantageous
- Knowledgeable in aseptic handling techniques
- Experience with analytical methods to detect protein denaturation and aggregation as well as to detect/characterize particles in solution is advantageous
- Affinity for working hands-on with complex equipment and solve related technical problems
- Proficiency in spoken and written English
- German language skills are advantageous
- Record of scientific initiative and creativity in research or development activities
- Capable of independently designing and executing experiments, evaluating data statistically, interpreting data, and identifying appropriate follow-up strategies

**Here's how we can move mountains together**

- 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>)

Other Non-US

Senior Director, Safety Data Sciences

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:**

The Head of Safety Data Sciences provides strategic, scientific and operational leadership for the Safety Data Sciences function within Global Patient Safety. The role is designed for an accomplished signal detection and surveillance leader who combines deep pharmacovigilance expertise with a forward-thinking, technology-enabled mindset. The Head of SDS will advance modern, data-driven approaches to safety surveillance and signal management across the AbbVie portfolio, including the thoughtful and responsible use of automation, analytics and AI helping to drive AbbVie's mission to deliver compassionate and innovative treatments that enhance patients' quality of life.

**Key Responsibilities:**

- Lead a global team of 40+ physicians, pharmacists and healthcare professionals accountable for signal detection, safety surveillance and aggregate safety data analysis across the AbbVie portfolio, fostering accountability, scientific rigor, curiosity and mutual commitment.

- Set the strategic direction for signal detection and surveillance, ensuring approaches are proactive, scalable and scientifically robust across development and marketed products.

- Bring deep expertise in diverse safety data sources, including clinical trial data, spontaneous adverse event reports, real-world data, literature, electronic health records and preclinical findings, and guide the team in integrating these sources to identify, evaluate and contextualize potential signals.

- Champion forward-thinking methods for the analysis and interpretation of safety data, including exploratory analytics, advanced visualization, automation and AI-enabled capabilities, while ensuring that all approaches remain compliant with global pharmacovigilance regulations and AbbVie guardrails.

- Continuously advance signal management capabilities through fit-for-purpose tools, technology, training and mentorship, building organizational confidence in responsible AI and digital transformation in safety surveillance.

- Ensure strong understanding of fast-evolving global PV regulations and translate external expectations into effective internal processes, procedures and standards that maintain compliance and support high-quality safety decision-making.

- Mentor and develop a diverse, multidisciplinary team, promoting professional growth, inclusive leadership, scientific excellence and a mindset of innovation.

- Partner with TA Heads to ensure appropriate cross-functional Safety Data Sciences support for each therapeutic area within Global Patient Safety.

- Partner with the Safety Data Architect team to deliver seamless, optimized and technology-enabled signal management approaches for development products, including aligned strategies, clear communication channels for ongoing monitoring and protocols for safety issue escalation and resolution.

- Lead the SDS team in the development and execution of major pharmacovigilance deliverables, including safety assessments, regulatory responses, risk management plans, PSURs and PADERs, in alignment with TA safety physician strategy.

- Drive continuous process improvement across surveillance, signal management and aggregate data analysis, using data, technology and stakeholder feedback to improve quality, efficiency and consistency.

Qualifications

- Advanced degree required (MD, PharmD, PhD) with 15+ years of experience in Pharmacovigilance and Drug Safety – in industry/academia and comprehensive expertise in product lifecycle from first-in-human studies to post-marketing preferred.
- At least 8 years of leadership experience managing global teams, with demonstrated success in driving impactful change preferred.

- Strong ability to lead diverse teams and influence senior leadership across global patient safety, R&D and Abbvie, fostering a culture of innovation and excellence in safety science and safety data analysis and interpretation.

- Excellent skills in relationship management and communication, underpinned by emotional intelligence

- Thorough understanding of global PV regulations, risk management, labelling and the interconnectedness of safety science, real world data and drug development.

- Strong and seasoned leader able to lead, motivate and inspire a diverse and team located across multiple geographical locations.

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>)

Site Management Lead - (Clinical 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.co.uk](<http://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

The SML reports into the Associate Director/Sr. Manager, Global Site Management and provides direction and operational expertise for all Clinical Site Management (CSM) integrity, quality, and timeliness of activities in assigned studies. The position can be assigned to serve as the overall CSM functional study strategy leader and/or can be assigned to manage area site execution activities in collaboration with other assigned SMLs dependent on size, complexity, and geographic scope of assigned studies.

Influences and aligns within Clinical Development Operations, with other assigned Site Management leaders, and key stakeholders in assigned studies. Accountable for driving study level global and/or area level CSM deliverables by targeted timelines with allocated resources for their assigned studies.

Responsibilities

- Analyze study timelines and overall study assumptions to confirm deliverables are feasible for CSM.
- Support and communicate CSM resource needs with Country Leaders in alignment with study deliverables and milestones.
- Accountable for study level site monitoring strategy, documented in Site Monitoring Plan.
- Accountable to set and lead Site Engagement Strategy.
- Ensure study-level and/or area-level timelines are maintained across the study lifecycle.
  Provide timely and essential study information for country-level teams to execute milestones
  Drive site-level activities at study level and/or area level, including site selection, activation, site engagement, protocol adherence and close out.
- Oversee monitoring activities at study and/or area level in collaboration with other assigned SMLs as applicable, ensuring quality deliverables, status tracking, and milestone adherence and acceleration if applicable.
  Drives CSM deliverables during data snapshots and database locks, aligned to Data Cleaning Plan.
  Ensure sites are closed per Site Closure Plan.
- Proactively identify, evaluate, and mitigate risks, ensuring effective action plans; key contributor to Risk Assessment and Mitigation Plan (RAMP).
  Collaborate with other assigned SMLs and stakeholders in the Clinical Study Team to address and manage risks to align with overall study execution.
  Ensure site compliance, escalate issues, and analyze trends for continuous improvement.
- Responsible for providing inputs on expected CSM documents at the study level and driving TMF completeness for CSM artifacts.
  Responsible from study start to close for ensuring that on-going CSM Inspection Readiness activities are completed at the study level.

Qualifications

- Bachelor’s Degree or equivalent OUS degree, typically in (para)medical or scientific field.
- Preferred exposure in study initiation through study completion in multiple phases of studies (Phase II and III, Phase I in patients). Experience in multiple therapeutic areas or disease state/indications highly desired.
- Demonstrates a high level of core and technical competencies through management of various components of clinical trials.
- Possesses good communication skills and demonstrated leadership abilities. Able to influence without authority in a matrix environment.
- Competent in application of standard business procedures (Standard Operating Procedures, International Conference on Harmonization (ICH), Global Regulations, Ethics and Compliance).
- Demonstrated good written and verbal communication skills including fluency in English. Excellent planning and organizational skills and the ability to work effectively and efficiently in a dynamic, fast-paced environment.
- Strong ability to create and deliver presentations.
- Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft OneNote

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 - Process Engineering

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

Are you a passionate engineer who thrives at the intersection of science, innovation, and impact? AbbVie's **Research and Development Process Engineering** team is on the front lines of transforming cutting-edge science into life-changing medicines — and we're looking for a **Principal Research Engineer I**/II to help us push the boundaries of what's possible in drug product development. Join us at our North Chicago, IL hub and be part of something bigger.

This isn't just a role — it's an opportunity to **shape the future of drug manufacturing**. You'll bring your **proven project leadership in drug product development** to drive synthetic molecule candidates from concept to commercial-ready processes, making real decisions that accelerate medicines to patients who need them most.

You'll be a master of **drug product manufacturing platforms** — direct compression, wet & dry granulation, hot melt extrusion, tableting, encapsulation, and film coating — and you'll apply your deep understanding of **powder material properties** to unlock new levels of manufacturability and product performance. When challenges arise, you're the person who steps up to **troubleshoot complex process and material issues** with creativity and rigor. And when it's time to go big, you'll translate bench-scale breakthroughs into pilot plant realities through expert **scale-up execution**.

At AbbVie, we celebrate bold ideas, encourage experimentation, and give talented engineers the resources and autonomy to *actually innovate*. If you're ready to raise the bar, lead with influence, and leave your mark on some of the world's most important medicines — we want to hear from you.

**Key responsibilities include:**

- Lead drug product manufacturing process early phase development for synthetic molecule development candidates within the AbbVie pipeline.
- Collaborate with development CMC teams to ensure manufacturing processes are aligned with intended commercial manufacturing sites.
- Advance scientific expertise within the function — mentoring peers and influencing senior leadership with your expert insights.
- Drive the development of technologies and scientific innovations that expand AbbVie's small molecule formulation capabilities.
- Partner cross-functionally to build strategies that directly power AbbVie's drug discovery and development programs.
- Champion compliance with AbbVie's safety, quality, and regulatory standards.

Qualifications

- BS (+14 yr experience) MS (+12 yr. experience) or PhD (+6 yr experience) in Chemical Engineering, or equivalent scientific/engineering degrees
- Strong project leadership experience for drug product development.
- Advanced understanding drug product manufacturing platforms with direct compression, wet & dry granulation, and hot melt extrusion which include tableting, encapsulation and film coating.
- Advanced understanding of powder material properties and their impact on drug product manufacturability and final product performance.
- Ability to apply/interpret models during drug product development to optimize development.
- Experience writing regulatory submissions and generating the data required to gain approval
- Demonstrated ability to troubleshoot process/material issues.
- Apply techniques to scale-up the development process to pilot plant equipment.
- Displays technical awareness in various aspects of drug development, adherence to rigorous scientific methods, and commitment to the scientific process.
- Strong drive for learning new techniques and technologies.
- Excellent oral and written communication skills.
- Demonstrated ability to work collaboratively in a cross-functional team setting.

Preferred:

- Drug Substance Crystallization development knowledge

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>)

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

Responsible for supporting the Product Safety Leads (PST) and potentially support one or more products as the PST Lead under the direction of the Therapeutic Area (TA) Lead and Global TA Head in ensuring safety in one or more products to through surveillance, signal detection, validation and assessment. Interpreting regulations related to pharmacovigilance supporting all patient safety activities.

Responsibilities

Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance

- Safety surveillance for pharmaceutical / biological / drug –device combined products
- Contribute to the authorship of key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans
- Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
- Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams
- Ability to effectively write, review and provide input on technical documents
- Lead the strategy for periodic reports (PSUR’s, PADER’s etc.)
- Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials and post marketing
- Lead and implement risk management strategy for assigned products

Qualifications

- MD / DO with 2+ years of residency with patient management experience and Master Public Health is preferred in addition to MD / DO but not required
- 2 – 4 years of Pharmacovigilance experience in the pharmaceutical industry
- Effectively analyze and guide analysis of clinical data and epidemiological information
- Effectively present recommendation / opinions in group environment
- Write, review and provide input on technical documents
- Self-starting and can work independently
- Work collaboratively and lead cross-functional teams

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 Scientist I/II, Process Engineering

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

Process Engineering, a part of AbbVie R&D’s Small Molecule CMC Development organization, is responsible for designing and developing scalable processes to make small molecule drug substances and drug products, including antibody drug conjugates (ADCs), throughout pre-clinical and clinical development stages. Process Engineering also partners with Biologics CMC Development and Aesthetics R&D functions to provide active engineering support to enable robust process scale-up and manufacturing of biologics drug substances and drug products, including toxins and cosmetic active ingredients (CAIs). We contribute to the development of innovative engineering technologies and create valuable intellectual property through the composition of matter, chemical processes, and technologies resulting in cost-effective commercial manufacturing processes. We support the development of the supply chain for pipeline molecules and help prepare and defend CMC regulatory content.

Chemical/Bio Engineers support pipeline projects through all phases of development. Early in development, engineers focus on ensuring that the process can be run safely, identifying and addressing scale-up issues, enabling processes that can be scaled-up successfully. In the later stages of development, engineers optimize the drug substance and drug product processes and lead manufacturing campaigns. Engineers also work cross-functionally to transfer the optimized process to manufacturing sites, develop control strategy, and prepare reports to support regulatory filings.

**Role Overview**

The successful candidate will play a key role in the Center of Excellence in Crystalline Drug Substance and Drug Product (CrySP), a part of Process Engineering function. The core deliverable of Process Engineering is to develop robust processes to manufacture small molecule Active Pharmaceutical Ingredients (API), Antibody Drug Conjugates (ADCs), toxins, cosmetic active ingredients (CAIs), and drug products utilizing strong engineering fundamentals. The idea candidate will have background in crystallization fundamentals and crystallization process development. Process Engineering also leads the development of isolation and purification strategies for both small and large molecule compounds. The ideal candidate will have a passion for hands-on laboratory process development and a proven track record in research and development. The candidate is also expected to lead the identification and development of novel approaches and technologies to enhance process development efficiency and commercialization. The candidate must exhibit a collaborative nature in identifying process challenges on a wide range of projects and participate in a cross-functional teams to deliver against specific project needs.

**Key Responsibilities:**

- Develop robust scale up and manufacturing processes, supporting small and/or large molecule assets through all phases of development.
- Perform laboratory experiments and process modeling to support process understanding and optimization.
- Address challenging problems with separations, and/or isolations using expertise in thermodynamics, crystallization fundamentals, transport phenomena, and mathematical modeling.
- Author and/or review technical documents summarizing process development efforts.
- Exhibit a collaborative nature in identifying process challenges on a wide range of projects and communicate findings and recommendations effectively by multi-disciplinary interactions with organic chemists, analytical chemists, process development engineers, pilot plant engineers, drug product development scientists, program managers, and regulatory affairs specialists.
- Author publications and present at scientific conferences.

Qualifications

- BS, MS, or PhD in Chemical Engineering or a related field and 10+ (BS), 8+ (MS), or 0+ (PhD) years of relevant industrial experience.
- Job level will be commensurate with academic and/or industrial work experience.
- Candidates are expected to have a strong background in chemical engineering and the proven ability to demonstrate their skills in this field.
- The candidate is expected to demonstrate the ability to learn, understand, and master new experimental techniques.
- The candidate is required to possess effective oral and written communication skills and be a strong team player.

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>)

Senior Clinical Operations Manager

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 Sr. Clinical Operations Manager (Sr. COM) is accountable for building and leading high performing clinical research teams who partner with investigative sites for meaningful and effective engagements, striving to position AbbVie as the partner of choice in clinical trials. Supports Country Head with strategic Country management activities as assigned, including resource, finance / budget, study delivery, TA assignment, and people leadership.

For countries where Sr.COM has overall country responsibility:

Accountable for country clinical trial performance, providing strategic planning, oversight and direction of the country team to ensure on time, within budget and quality delivery of clinical studies. Establish partnership with internal stakeholders to drive insightful and impactful interactions and promote the value of the clinical research team through the contribution to the R&D portfolio success.

Responsibilities

- Responsible for the hiring, retention, performance management, mentoring, task assignment, growth, and development of their clinical research team.
- Provide leadership and oversight to the clinical research team including, but not limited to:
  \* performs accompanied visits (on-site and off-site)
  \* accelerates AbbVie's priority programs through close collaboration with internal and external stakeholders
  \*conducts trend analysis and gap assessments to proactively identify training and developmental opportunities for assigned personnel
  \* addresses gaps effectively to help assigned personnel achieve country and site level KPIs and metrics.
- Utilizes AbbVie systems and tools to proactively address performance and mitigate risks and issues. Proactively identifies individual needs of their team members, removes obstacles, proposes solutions, and tailors support to enable successful, on-time monitoring and / or delivery of their assigned study activities.
- Ensures adherence to applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to quality standards in conducting clinical research. Stay abreast of new and/or evolving local regulations, guidelines and policies. Supports, trains and oversees assigned personnel to ensure that they maintain audit and inspection readiness at assigned sites/studies. Prepare and follow up on site and country audits, CAPA preparation and implementation.
- Accountable for resource management for assigned team, as follows:
  \*Utilizes reports from available systems and country/area model to accomplish
  \*In alignment with AbbVie research goals, priorities, an specific study timelines
  \* Ensure resource utilization to address business priorities and maximize team impact to delivery of the pipeline.
- Accountable for the budget management and payments of the assigned studies conducted by their assigned team, as applicable. Creates an inclusive environment to enable team members to reach their full potential. Helps team connect strategy to execution and promotes collaboration with stakeholders to effectively deliver pipeline. Leads and supports the team to understand the business strategy and vision. Drives and implements change through effective communication and management.
- Partners with research sites with high levels of coordinated and impactful site engagement with KOLs, National Leads, Principal Investigators and site staff positioning AbbVie as the partner of choice in clinical trials. May participate and/or lead global/local task forces and initiatives. Responsible for activities as assigned by Line Manager. Proactively identifies opportunities at local/ global levels and proposes solutions to create efficiencies and streamline/improve processes.
- Working with the Country COM, may be responsible for resource management of entire country/ies. Provide ongoing assessment and input towards resource needs and in allocating resources in alignment with AbbVie's research goals, priorities, and specific study timelines. Proactively identify and communicate issues impacting resource allocation and provides solutions. Working with the Country COM, may be responsible for functional budget planning & oversight of expenses across country/ies.
- Supports the Country COM in conducting country feasibility, implementing site selection strategy, and expanding AbbVie's site footprint within the country. Supports the Country COM in driving insightful and impactful interactions with key R&D external stakeholders and agencies.
- May be assigned TA responsibility within an affiliate or lead COM's supporting multiple TA's. Support training and monitoring for the team. Develop and implement strategies to support site and KOL / National leaders identification (including in study feasibility) to support Abbvie pipeline execution within the Country or Region. Work with affiliate teams (including Medical Affairs or Commercial brand teams as appropriate) for assigned TA's.

Qualifications

- Education: Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred.
- Monitoring Experience: Minimum 5 years plus at least 1 year of direct line management experience preferred.
- Advanced interpersonal skills with the ability to communicate persuasively with clarity, collaboratively, and cross functionally.
- Exhibits strong planning and organizational skills. Experience across multiple therapeutic areas and study phases.
- Excellent mentoring and coaching skills. Has the ability to provide transparent and timely feedback to raise the bar on individual and team performance.
- Drives innovation and continuous process improvement.
- Acts with integrity in accordance with AbbVie code of business conduct and leadership values.
- Deals comfortably with risk and ambiguity, changing course when needed.
- Ability to make timely, high-quality decisions based on available data and information.
- Ability to work independently and take initiative/ownership. Ability to adapt and move quickly

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>)

Director of CMC, External Operations

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

**Scope & Purpose:**  The Director of CMC, External Operations will provide strategic leadership for outsourced CMC development, leveraging external partnerships to ensure the timely, high-quality execution of CMC activities that support clinical development and accelerate clinical proof of concept (cPOC). The primary focus of this role is the identification, qualification, selection, management, and oversight of external manufacturing partners in China to ensure the reliable delivery of GMP clinical supplies and regulatory-compliant CMC development activities.

This role will be accountable for developing and executing CMC outsourcing strategies, overseeing external development and manufacturing programs, ensuring technical excellence and quality compliance across outsourced activities, and serving as the primary CMC interface between AbbVie and external partners.

The individual will drive program execution, proactively manage risks, and ensure external CMC activities are aligned with program timelines, quality standards, and regulatory expectations. Additionally, he/she will also provide support to regulatory submissions.

**Main Responsibilities:**

1. Develop and execute CMC strategies aligned with clinical development timelines and regulatory requirements. Serve as a CMC lead on AbbVie’s project team.
2. Identify, evaluate, select and manage CMO/CDMO partners based on technical capabilities, quality systems, capacity, timelines, and cost considerations. Lead due diligence and technical assessment of potential manufacturing partners.
3. Lead the negotiation of the Manufacturing Service Agreement, ensure that effective planning and materials procurement strategies are in place.
4. Establish effective governance models with external partners, including communication plans, oversight strategies, project milestones, risk management, and performance monitoring.
5. Serve as the primary AbbVie CMC point of contact and ensure successful execution of outsourced activities, including process development, analytical development, formulation development, GMP manufacturing, fill-finish, packaging, and stability studies. Monitor progress, identify potential technical and operational risks and implement mitigation strategies.
6. Review and provide technical oversight of manufacturing processes, batch records, process characterization, and technology transfer activities.
7. Partner with Quality Assurance, Regulatory Affairs to ensure compliance with applicable GMP and regulatory requirements. Ensure timely delivery of clinical trial materials.
8. Provide CMC input into regulatory submissions, including IND/CTA, IMPD, and other global filings.
9. Oversee preparation and review of CMC documentation, including Module 3 sections and supporting technical documents, supporting regulatory interactions related to CMC activities.
10. Collaboration with cross-functional teams including research, nonclinical, clinical operations, regulatory affairs, and clinical drug supply teams to support program advancement. Maintain ongoing communication with the appropriate AbbVie US stakeholders about CMC progress, risks, and recommendations throughout the manufacturing cycle.

Qualifications

1. PhD, MS, or equivalent degree in pharmaceutical sciences, chemistry, biology, biotechnology, or a related field.
2. A minimum of 10 years of CMC development experience within the biopharmaceutical industry, with a demonstrated track record of leadership and successful cross-functional collaboration.
3. Proven experience managing external manufacturing partners, including CMOs/CDMOs.
4. Strong understanding of biologics development, GMP manufacturing, analytical development, and regulatory CMC requirements.
5. Experience supporting clinical-stage programs and regulatory submissions.
6. Strong project management, negotiation, communication, and problem-solving skills.
7. Ability to work independently and effectively manage multiple programs in a fast-paced environment.
8. Knowledge of regulatory requirements from CDE, FDA, and/or EMA.
9. Experience leading CMC activities from early development through late-stage clinical programs.
10. Excellent communication and negotiation skills, with fluency in spoken Mandarin and English highly preferred.

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>)

Senior Medical Director, Neuroscience, Global Patient Safety

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 :**

Describes the primary goals, objective or function or outputs of this position. Responsible for supporting the Product Safety Leads (PST) and potentially support one or more products as the PST Lead under the direction of the Therapeutic Area (TA) Lead and Global TA. Head in ensuring safety in one or more products to through surveillance, signal detection, validation and assessment. Interpreting regulations related to pharmacovigilance supporting all patient safety activities.

**Responsibilities**

- Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
- Safety surveillance for pharmaceutical / biological / drug –device combined neuroscience products
- Contribute to the authorship of key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans
- Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
- Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams
- Ability to effectively write, review and provide input on technical documents
- Lead the safety strategy for regulatory submissions, including INDs, NDAs, and MAAs and the periodic reports (PSUR’s, PADER’s etc.)
- Oversight of safety surveillance and pharmacovigilance activities for neuroscience products in clinical trials and post marketing
- Lead and implement risk management strategy for assigned neuroscience products

Qualifications

- MD / DO with 2+ years of residency with patient management experience and Master Public
- Health is preferred in addition to MD / DO but not required
- 2 – 4 years of Pharmacovigilance experience in the pharmaceutical industry
- Effectively analyze and guide analysis of clinical data and epidemiological information
- Effectively present recommendation / opinions in group environment
- Write, review and provide input on technical documents
- Self-starting and can work independently
- Work collaboratively and lead cross-functional teams

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>)

Medical Lead, Singapore & Distribution Markets and Medical Launch Lead, Asia

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

**This position is responsible for:**

- Current and upcoming Medical Aesthetics portfolios and their associate indications.
- Medical representative for compliance (in- & out-office), for media regarding medical aesthetics
- Own and drive Key Opinion Leaders (KOL) engagement
- Lead scientific exchange with HCPs
- Lead brand strategy, budget management, development of tactical planning in collaboration with brand team in marketing department
- Contribute to the total competency of the Medical Affairs, not limited to technical aspects.
- Lead medical launch preparations for effective key launches across Asia markets, in close collaboration with cross-functional colleagues and local country medical leads.

**Position Overview**

- Develops and maintains professional relationships with internal and external customers to provide comprehensive medical and scientific support to Allergan initiatives in assigned therapeutic areas.
- Executes against the Medical Affairs plan for Singapore and Distribution Markets.
- Provides scientific education and training initiatives across Allergan Aesthetics portfolio.
- Performs field visits with key physicians and stakeholders, organizing advisory board meetings, facilitating clinical trials, and serving as the medical resource for both external and internal stakeholders.
- This position is a non-promotional role. The primary focus is providing Healthcare Professionals with fair and balanced scientific information.
- Facilitates information, education, and research activities for physicians and ancillary healthcare professionals regarding current and future therapies in development or commercialized by Allergan Aesthetics. Works closely with other personnel to ensure information, education, and research needs of healthcare professionals are met and to ensure scientific and technical training needs of commercial organizations are identified and met.
- Lead medical launch preparations (pre-launch, launch and post-launch initiatives) for effective key launches across Asia markets, in close collaboration with cross-functional colleagues.
- A high level of travel / field time is to be expected within this position (approximately 60% of time spent outside the office). This role will also serve as the local representative of the Global Medical Office associated functions. (eg PV, HEOR etc)

**Business Planning**

- Work closely with the Commercial Leaders and Medical Affairs Director to set priorities and activities.
- Develop strategies and tactics for the Medical Aesthetics portfolio and implement them in a timely manner to align with commercial strategies, including medical launch preparedness for key launches across Asia markets.
- Develop and maintain awareness and understanding of competitor issues and intelligence.
- Contribute to maintaining competitiveness and growth within the market and communicate relevant intelligence to the commercial team.

**Internal Training**

- Facilitate training for field sales teams and other stakeholders to ensure up-to-date knowledge of Aesthetic products, including current and upcoming launches, relevant disease states, and conditions.
- Provide interpretation and perspective on competitor activities.
- Assist in evaluating field sales team skills and knowledge.
- Ensure scientific capability building for upcoming launches across the Asia region.
- Assist in developing training materials, examinations, and evaluation processes for field sales teams.

**External Training and Education**

- Through field visits, improve physicians' awareness of Aesthetic products.
- Share scientific data supporting product use, train healthcare professionals on appropriate use, and develop physician expertise and confidence in prescribing products.
- Work closely with the commercial team to facilitate physician training and ensure effective engagement with thought leaders and healthcare professionals.
- Help shape the company's leadership image within the specialty area, including medical launch preparedness for key launches across Asia markets.
- Identify and engage doctors-in-training whose specialty interests align with the company's therapeutic areas through educational initiatives.
- Provide scientific and clinical information to healthcare professionals upon request.

**Thought Leadership**

- Identify key researchers and physicians who are critical to disease awareness and the knowledge base supporting Aesthetic products within the specialty area.
- Facilitate understanding of medical practice patterns, educational needs, and training requirements; organize local activities with key stakeholders, including medical launch preparedness for key launches across Asia markets.
- Present and communicate the company's scientific perspective and vision at customer meetings.
- Plan meeting agendas with key stakeholders and interpret feedback and outcomes.
- Maintain key relationships with physicians and administrators of specialty societies.

**Phase IV Trials and Clinical Studies**

- Identify and prioritize Phase IV and Investigator-Initiated Trial (IIT) opportunities.
- Ensure approval processes and execution of all Phase IV studies and IITs comply with company guidelines and policies.

**Pharmacovigilance and Compliance**

- Provide support to Local Safety Officers (LSOs) on local pharmacovigilance issues and required actions.
- Liaise with the Regional Pharmacovigilance Lead (RPL) on support requirements, including product safety issues, health authority inspections and audits, CAPAs, and training activities.

**Clinical Expertise**

- Maintain up-to-date knowledge of scientific developments within the specialty area locally, across Asia, and globally, with a focus on medical launch preparedness for key launches across Asia markets.
- Attend relevant local and international medical congresses as required to expand medical knowledge, provide medical expertise to commercial teams, establish new professional relationships, and strengthen existing stakeholder relationships.

Qualifications

**Education and Experience**

- Strong preference for medical degree (MD or MBBS), PhD or Science degree
- Minimum of 2 – 7 years of medical affairs experience in the pharmaceutical industry, with specialized therapeutic areas
- Related specialist in Dermatology or experience in Dermatology, Plastic surgery or Medical Aesthetics therapeutic area is preferred
- Medical affairs experience in various activities such as advisory board management, publication, and other scientific exchange, in adherence with policies and procedures.
- Good understanding of domestic market
- Experience in establishing strong influential relationships with KOLs
- Good understanding on multinational culture and ways of working, also willingness to travel.
- Experience of working collaboratively and cross-functionally in a matrix structure, supporting multiple stakeholders
- Good leadership skills and able to persuade at all levels within the organization (including Commercial team) as well as with external customers (KOLs, HCPs, etc.)
- Thinking strategically and being able to develop and execute plans at country level
- Specifically, able to understand in-depth knowledge and clinical aspects of the medical aesthetics
- Excellent presentation skills, strong interpersonal skills
- Able to engage HCPs and communicate effectively with them as well as medical institution and/or association
- Comply to all business ethic and all applicable regulations to secure personal credibility and integrity
- Demonstrated ability to learn quickly and convey clinical and non-clinical technical information effectively to individuals with varying degrees of scientific acumen.

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>)

Senior Director, Business Operations

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

**ROLE PURPOSE**

Serve as the senior strategic and operational partner to the VP of Development Sciences, enabling the Development Sciences Leadership Team to translate strategy into disciplined execution, effective governance, sound resource stewardship, and a high-performing, inclusive organization. The role leads business operations and chief-of-staff activities across the global function.

**KEY RESPONSIBILITIES**

1. Strategic partnership and execution: Advise the VP and Leadership Team on priorities, trade-offs, decisions, and follow-through; convert strategic objectives into integrated operating plans, milestones, risks, and performance indicators.

2. Strategic communications: Shape clear, timely, audience-appropriate communications for leadership forums, organization-wide updates, executive materials, and key external interactions; ensure consistent strategic narrative and message discipline.

3. Leadership-team effectiveness and culture: Design and facilitate effective leadership-team rhythms, agendas, decision forums, and off-sites; strengthen accountability, inclusion, collaboration, and an environment in which teams can perform at their best.

4. Financial planning, forecasting, and resource management: Lead internal and external financial planning, rolling forecasts, investment tracking, vendor/resource oversight, and scenario analysis; provide transparent insights that support responsible resource allocation and delivery.

5. Compliance and governance: Establish and maintain fit-for-purpose governance, controls, policies, decision records, and inspection-ready business processes; partner with relevant functions to identify, escalate, and mitigate operational and compliance risks.

6. Business excellence and organizational improvement: Lead continuous-improvement initiatives that simplify processes, improve operating discipline, enhance data quality, and strengthen organizational capability across Development Sciences.

7. Cross-functional collaboration: Build trusted partnerships across R&D, Finance, Procurement, Quality, Legal, HR, Communications, and other global functions to remove barriers, align dependencies, and advance shared outcomes.

8. Ludwigshafen site operations: Provide core business-operations leadership for the Ludwigshafen site, including site planning, operating rhythms, issue resolution, and local engagement, in close partnership with local site leadership and global partners.

9. Organizational insight and reporting: Maintain a concise view of organizational performance, capacity, risks, decisions, and commitments; deliver actionable reporting and recommendations to the VP and Leadership Team.

**KEY STAKEHOLDERS**

• VP of Development Sciences and Development Sciences Leadership Team

• Development Sciences colleagues and functional leaders

• Ludwigshafen site leadership, site services, and local employee representatives, as applicable

• Global R&D, Development, Finance, Procurement, Quality, Legal, HR, Communications, and external partners

Qualifications

**REQUIRED QUALIFICATIONS**

**LEADERSHIP BEHAVIORS/CAPABILITIES**

• Sets direction with enterprise perspective; balances long-term strategy with practical, timely execution.

• Builds trust through integrity, transparency, discretion, and reliable follow-through.

• Leads through influence, creates alignment across differing priorities, and makes thoughtful decisions amid ambiguity.

• Develops inclusive, accountable teams and actively seeks diverse perspectives to improve outcomes.

• Challenges constructively, learns continuously, and drives simplification and sustainable improvement.

**SCOPE AND ACCOUNTABILITY**

• Accountable for the effectiveness of the Development Sciences business operating model, leadership cadence, strategic communications and execution tracking.

• Owns coordination of functional financial planning, and resource-management processes.

• Operates across a global matrix, influencing outcomes beyond formal authority and ensuring risks, dependencies, and decisions are visible and managed.

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>)

Medical Director, Neuroscience, Global Patient Safety

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:**

To lead Product Safety Teams (PST) and support one or more products as the PST Lead, ensuring that the safety profile of one or more products is adequately monitored and characterized throughout the product lifecycle (e.g., surveillance, signal detection and evaluation, risk management, etc.). Interpreting regulations related to pharmacovigilance supporting all patient safety activities.

**Responsibilities:**

• Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance.

• Responsible for safety surveillance for pharmaceutical / biological / drug –device combination products

• Lead, oversee, and set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, risk management plans, periodic safety reports (DSURs, PBRERs/PSURs, PADERs), etc.

• Lead and oversee safety surveillance and pharmacovigilance activities for products in clinical development and marketed products, applying current regulatory guidance as appropriate

• Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams and regulatory authorities.

• Effectively and independently write, review, and present technical documents .

• Responsible for implementing risk management strategies for assigned products.

• Proactively engaging, inspiring, coaching and mentoring team and colleagues.

Qualifications

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>)

Associate Director, Clinical Trial Patient Safety

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**:

*This position supports the Clinical Trial Patient Safety (CTPS) organization to achieve its mission of*

*evaluating and ensuring the quality of clinical trial patient safety data by consistent and accurate delivery*

*of high-quality, relevant and timely data review. To create a culture of process improvement, employee*

*development, performance measures, project prioritization, and to develop/implement successful*

*solutions leading the CTPS team, translating the business vision into broad and actionable strategies.*

**Responsibilities**:

This position is responsible for world-wide surveillance of clinical trial patient safety data, including

organization, resourcing and continuous improvement efforts. Supports Director of CTPS.

**Core Job Responsibilities include:**

• Manages assigned operational area(s)compound associated clinical studies and related systems to

ensure clinical safety adverse event surveillance is managed in a compliant and timely manner

meeting quality outputs within an inspection-ready environment.

• Establish, monitor, evaluate, and communicate workload projections and metrics for operational

area(s).

• Supports department and divisional training programs, ongoing knowledge attainment, and

development of staff by effectively identifying department and division needs and successfully

presenting them to management.

• Creates and sustains an environment that attracts, develops, and retains talented scientific

professionals. Plans and conducts active talent management.

• Assist management with strategic planning and department development. Develop and participate in

special projects for respective teams or CTPS initiatives.

• Applies advanced knowledge of ICH, FDA, EMA regulations and guidelines affecting drug safety issues

to assigned responsibilities as they impact on CTPS processes, procedures, and global reporting

requirements.

• Partner with therapeutic area MDs/medical monitors to provide oversight of medical safety review at

the compound study level, including ad-hoc safety reports, IRB/IEC safety issues, narratives, etc.

• Provide oversight of narrative deliverables, issue management, document management systems, and

centralized data review for assigned compound associated clinical studies. Effectively

communicates/escalates relevant study and/or team-related information to appropriate clinical team

members and/or management.

• Understands, implements and improves department SOPs as part of continuous improvement,

including implementation of new regulatory requirements.

• Aligns and maintains effective communication channels with key clinical, medical, study team, including regulatory, compliance, and pharmacovigilance counterparts.

Provides perspective, insight and benchmark information and approaches for business-related initiatives.

• Manages 5 to 10 people.

Qualifications

- Bachelor’s degree in a healthcare discipline (i.e. Life Science, Pharmacy, Nursing or healthcare profession, or biomedical disciplines). Graduate degree preferred. 10 years of experience in clinical research in the pharmaceutical industry.
- Project management experience with cross-functional projects. Knowledge of the drug development process which includes clinical trial conduct, scientific strategy and operations management for the planning, execution and reporting of clinical development programs, regulatory requirements for submission, product launch and post marketing support.
- Experience in one or more of the following areas: clinical operations management, clinical study management, drug development, risk management, and/or drug safety operations. Understanding tools, standards and approaches to efficiently evaluate drug safety.
- Demonstrated effectiveness in working in a multidisciplinary, matrix team environment with the ability to manage change.
- Leadership and communication skills that minimally include: effective and timely communication of project objectives, issues/risks and other project information required to keep the team and management informed.
- Demonstrated sound judgment to manage conflict and negotiations constructively and develop effective working relationships to enable high performing teams.

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>)

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>)

Head of Multiple Myeloma & AML, Oncology - Global Patient Safety

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

Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors, and Executive Medical Directors. Leading Product Safety Teams (PST) and support one or more products as the PST Lead and ensuring safety of one or more products through the product lifecycle (e.g. surveillance, signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities.

Responsibilities

- Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
- Responsible for safety surveillance for pharmaceutical / biological / drug –device combined products
- Lead and set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans
- Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
- Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams
- Effectively write, review and provide input on technical documents independently
  Oversight and responsibility for leading the strategy for periodic reports (PSUR’s, PADER’s etc.)
- Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials and post marketing
- Responsible for implementing risk management strategies for assigned products
- Proactively engaging, inspiring, coaching and mentoring team and colleagues
- Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors: performance and talent management, coaching and development.
- Assumes responsibility for coordinating and overseeing safety related activities at a product level across multiple indications or multiple related products for the same indication. Is responsible for assessing product safety strategy across the entire program and for overseeing approval related activities.

Qualifications

- MD / DO with 2+ years of residency with patient management experience
  Master Public Health is preferred in addition to MD / DO, not required
  8 - 10 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry
- Effectively analyze and guide analysis of clinical data and epidemiological information
  Effectively present recommendations / opinions in group environment both internally and externally
- Write, review and provide input on technical documents
  Work collaboratively and lead cross-functional teams
- Ability to lead cross-functional teams in a collaborative environment
  Fluency, both written and oral, in English
- • Evaluate and make independent decisions. Ability to work effectively in the situation of uncertainty and complexity, ability to multitask

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>)

Site Management Lead

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 SML provides direction and operational expertise for all Clinical Site Management (CSM) integrity, quality, and timeliness of activities in assigned studies. The position can be assigned to serve as the overall CSM functional study strategy leader and/or can be assigned to manage area site execution activities in collaboration with other assigned SMLs dependent on size, complexity, and geographic scope of assigned studies.

Influences and aligns within Clinical Development Operations, with other assigned Site Management leaders, and key stakeholders in assigned studies. If assigned as the study strategy leader, is a key member of the Clinical Study Team representing CSM globally from study planning to close out. If assigned to area site execution activities, responsible and accountable for directing site monitors in a matrix environment and serve as a liaison and primary contact between site monitors, the study strategy leader, and the Clinical Study Team.

Responsibilities

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

- Accountable for driving study level global and/or area level CSM deliverables by targeted timelines with allocated resources for their assigned studies.
- Analyze study timelines and overall study assumptions to confirm deliverables are feasible for CSM.
  Support and communicate CSM resource needs with Country Leaders in alignment with study deliverables and milestones.
  Accountable for study level site monitoring strategy, documented in Site Monitoring Plan.
  Accountable to set and lead Site Engagement Strategy.
- Ensure study-level and/or area-level timelines are maintained across the study lifecycle.
  Provide timely and essential study information for country-level teams to execute milestones.
  Drive site-level activities at study level and/or area level, including site selection, activation, site engagement, protocol adherence and close out.
- Oversee monitoring activities at study and/or area level in collaboration with other assigned SMLs as applicable, ensuring quality deliverables, status tracking, and milestone adherence and acceleration if applicable.
  Drives CSM deliverables during data snapshots and database locks, aligned to Data Cleaning Plan.
  Ensure sites are closed per Site Closure Plan.
- Proactively identify, evaluate, and mitigate risks, ensuring effective action plans; key contributor to Risk Assessment and Mitigation Plan (RAMP).
- Collaborate with other assigned SMLs and stakeholders in the Clinical Study Team to address and manage risks to align with overall study execution.
  Ensure site compliance, escalate issues, and analyze trends for continuous improvement.
- Responsible for providing inputs on expected CSM documents at the study level and driving TMF completeness for CSM artifacts
- Responsible from study start to close for ensuring that on-going CSM Inspection Readiness activities are completed at the study level

Qualifications

- Bachelor’s Degree or equivalent OUS degree, typically in (para)medical or scientific field.
- A minimum of 5 years + of industry clinical research experience including 2 year of monitoring or project management or equivalent experience on a global study.
- Preferred exposure in study initiation through study completion in multiple phases of studies (Phase II and III, Phase I in patients). Experience in multiple therapeutic areas or disease state/indications highly desired.
- Demonstrates a high level of core and technical competencies through management of various components of clinical trials.
- Possesses good communication skills and demonstrated leadership abilities. Able to influence without authority in a matrix environment.
- Competent in application of standard business procedures (Standard Operating Procedures, International Conference on Harmonization (ICH), Global Regulations, Ethics and Compliance).
- Demonstrated good written and verbal communication skills including fluency in English. Excellent planning and organizational skills and the ability to work effectively and efficiently in a dynamic, fast-paced environment.
- Able to work well within a team and autonomously. Thinks proactively.
- Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft OneNote

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>)