Regulatory

AbbVie

Associate General Counsel, R&D Innovation Legal

Company Description

**About AbbVie**

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

Job Description

As an Associate General Counsel in the R&D Innovation Legal group, you will support AbbVie’s R&D organization in navigating enterprise-critical issues in an evolving legal and regulatory environment as we work to bring new, innovative products to patients. This individual will be motivated by the opportunity to address and solve emerging issues with a strategic and creative business-oriented approach and provide expert counsel on decisions impacting our long-term pipeline strategies.

**Key Responsibilities**

Develop and provide strategic counsel to senior leaders within the Legal and Regulatory Strategy organizations on legal regulatory issues that impact pipeline development and product innovation. Assigned matters have significant impact to AbbVie overall. **This is a role advising the R&D organization and not on FDA promotional considerations or advising the Commercial organization**.

Provides legal support to Regulatory Affairs on critical and strategic regulatory filings and agency engagements relating to R&D issues impacting our investigational and on-market drug products.

Willing to develop an understanding of the **Inflation Reduction Act and other “Most Favored Nation” policies** to provide strategic counsel to the R&D organization.

Educates other AbbVie legal departments and business stakeholders on emerging laws, regulations and industry trends impacting AbbVie portfolio.

Proactively identifies highly complex legal issues related to assigned matters, develops creative and alternative solutions, and implements resolution.

Adopts a business oriented and creative approach to problem solving.

Identifies unmet needs and future legal issues and proactively proposes strategies to optimize outcomes and results for the company.

Advises Vice Presidents, Presidents and Officers. Recognized by these clients as both expert in substantive area and relied upon for individual advice.

**To be successful in this role**:

- You offer specialized FDA regulatory and drug development experience.

You have demonstrated success in providing strategic counsel to leaders within the pharmaceutical industry.

Qualifications

- J.D. and currently admitted to the bar in at least one U.S. state.
- Minimum of 10+ years (12+ preferred) of relevant experience practicing as a member of a nationally recognized law firm in a life sciences practice, practicing in-house at a pharmaceutical company or practicing as an attorney for the FDA, or any combination of the above (experience working in-house or at FDA is preferred).
- Individual will have substantial e**xpertise in FDA regulations** and guidance around innovator drug development, including on regulatory exclusivities, orphan drug designations, clinical trial design and data requirements and combination products, and have familiarity with policies to advance innovation in the industry.
- Experience working for, or having interactions with, government health authorities is highly desirable.
- Familiarity with the **Inflation Reduction Act, Most Favored Nation and CMS policies and their impact on drug development strategies is a plus**.
- Knowledge and understanding of pharmaceutical laws and regulations to help business clients assess issues in a highly regulated landscape.
- Demonstrated ability to work independently and lead cross-functional teams collaboratively.
- Ability to adapt to a changing environment while handling multiple priorities.
- Excellent oral and written communication skills. Comfortable presenting complicated information accurately and concisely to senior leaders.
- **To enable success in the role, an individual must be able to be in the office 3 days/week at our offices in North Chicago, IL or the Washington, DC metro area**.

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 postingbased 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 orless than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.

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

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

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

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

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

Illinois

Senior Clinical Research Associate

Company Description

**About AbbVie**

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

Job Description

PRIMARY FUNCTION/OBJECTIVE

To enable AbbVie’s emergence as a world class R&D organization, the position plays a key role in ensuring successful protocol level execution of SMM deliverables involving start-up, execution, and close-out of studies.

CORE JOB RESPONSIBILITIES

- For assigned sites/study(s), ensure successful protocol level execution of SMM deliverables involving start-up, execution, and close-out. Ensure site related study execution including but not limited to monitoring visits, site evaluations, site selection, and activation, and monitoring close out and visit reports. Anticipate and identify site issues that could affect timelines and develop alternative solutions.
- Ensure clinical trial management systems containing all site-specific information are maintained and kept current. Provide Local regulatory and legal requirement expertise. Ensures timely payment execution for the assigned sites/study(s) according to the clinical study agreements and as per local requirements.
- Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Stay abreast of new and/or evolving local regulations, guidelines and policies.
- Ensure audit and inspection readiness of assigned sites. Advise on pre-audit activities for GCP requirements. Prepare and follow up site audits/inspections; provide input into the CAPA preparation.
- Responsible for coaching and mentoring CRAs and providing input into their development. Responsible for mentoring CRAs for various aspects of work.
- May be responsible for being the country point of contact for CROs for an assigned study. May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager.
- If assigned; Responsible for identifying training needs and standardizing and facilitating training solutions for SMM monitors globally. Provide consistent best practice approach to onboarding, consolidating“lessons learned” across areas and incorporating into monitoring training materials, defining best practice training curriculum, and maintaining awareness of upcoming changes to ensure effective training is delivered in a timely manner.
- If assigned; With guidance, may serve as key point of contact in country/district for assigned study. Update Impact/Tesla with country-level information: Country-level planning timelines, LSR assignments, etc.
- If assigned; Global Representative for a single or multiple studies, collaborating with key stakeholders to achieve proactive, strategic and tactical success throughout the study planning, execution, and closeout phases leading to World Class clinical trials.
- If assigned; Responsible for remote data review of assigned sites/studies according to the Integrated Data Review Plan (IDRP), Monitoring Plan, SOP/WI and in accordance with the study timelines and objectives. Provides feedback on investigators/sites on an on-going basis based on the site performance. Interacts and builds professional and collaborative relationships with peers and site monitors.

Qualifications

- Education: Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred.
- Site Monitoring Experience: Minimum 5 years.
- Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making.
- Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity.
- Demonstrated proactive and positive team player.
- Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with competing projects and deadlines.
- Demonstrated business ethics and integrity.

Additional Information

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

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

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

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

Other Non-US

Clinical Research Associate I

Company Description

**About AbbVie**

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

Job Description

PRIMARY FUNCTION/OBJECTIVE

Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry leading performance. Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials. Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.

CORE JOB RESPONSIBILITIES

- Considered as the primary point of contact for the investigative site, provides contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie's positioning.
- Aligns, trains and motivates the site staff and principal investigator under supervision on the goals of the clinical trial program, protocol, and patient treatment principles for the trial ensuring a trusted
- partnership.
- Conducts site evaluation, site training, routine, and site closure monitoring activities under supervision, in compliance to the protocol and monitoring plans and accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to quality standards in conducting clinical research, ensuring safety and protection of study subjects.
- Customize site engagement strategy for assigned study (ies) under supervision. Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, toreport/track progress and measure impact of that strategy.
- Fundamental level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities.
- Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey.
- Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
- Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
- Ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution.
- Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.
- Identifies, evaluates and recommends new/potential investigators/sites under supervision and support from more experienced CRAs.
- Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
- Ensures audit and regulatory inspection readiness at assigned clinical site at all times.
- Manages investigator payments as per executed contract obligations, as applicable.

Qualifications

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

Additional Information

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

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

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

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

Regulatory Affairs Manager Advertising and Promotion

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. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube

Job Description

Responsibilities

• Provides International regulatory position, perspective, and expertise related to advertising and promotion to internal and external customers/business partners. Maintains current knowledge of international codes of practice, regulations and guidance that impacts pharmaceutical advertising and promotion.

• Collaborates and communicates effectively through all levels of management across multiple functions (Commercial, Medical, Legal, and Compliance) and with external faculty/ key opinion leaders. Recognized by organizational counterparts as a key company resource on pharmaceutical advertising and

promotion. Applies novel and creative methods to problem solving. Constantly searches for out of the box solutions while maintaining quality and adherence to regulations. Balances business needs and risk assessments with creative decision-making abilities, balancing innovation with risk.

• Has accountability for the sound representation of International Regulatory Advertising and Promotion position within and external to Allergan Aesthetics. Defines boundaries of accepted risk tolerance within assigned programs.

• Maintains current knowledge of international codes of practice, regulations and guidance. Demonstrates compliance with international codes of practice relevant regulations and provides input into brand strategy and key asset and therapy area initiatives, as required.

• Reviews and evaluates the global industry environment (e.g., regulatory, legal, and political climate) and competitive landscape (e.g. product strategies, commercial messages, positioning, etc.). Provides functional input on key initiatives impacting other areas. Leads the implementation of risk management strategies and risk management plans for International advertising and promotion activities.

• Lead operations, initiatives, and strategies for the International Regulatory Affairs Advertising and Promotion team.

• Share best practice and contribute to the development of marketing campaigns from concept creation and through execution in collaboration with crossfunctional partners.

• Provide guidance on International codes to affiliate markets as and when required and when required and confidently present competitive landscape cases to encourage team learning

• Supports departmental and business strategies, quality initiatives, compliance

with policies and procedures, and the implementation of improvement plans.

Contributes to the evaluation of departmental needs and implements solutions

to enhance and facilitate operations.

Qualifications

Preferred 7-10 years of pharmaceutical experience with a minimum of 5 years direct advertising and promotion regulatory experience

• The candidate must have a solid understanding of advertising and promotion regulations and UK and International Codes of Practices, having had direct responsibility in this area.

• Strong stakeholder management skills and multi-disciplinary team management. Proven 3-5 years in a leadership role preferred

• Strong communication skills, both oral and written, clear decision-making authority, experience handling compressed timelines.

• Experience with products at different stages of the life cycle

• Experience working in a complex and matrix environment

Additional Information

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

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

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

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

Principal Research Scientist I - Analytical R&D

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

For the Principal Research Scientist I position, we are seeking a highly motivated and experienced Process Analytical Technology (PAT) scientist to lead a small team within Analytical R&D. The candidate will establish and execute PAT strategies for synthetic molecule programs, supporting drug substance and drug product development from early development through validation, technology transfer, and manufacturing implementation. The role requires deep technical expertise in PAT method development, chemometrics, process understanding, and fit-for-purpose analytical control strategies.

The successful candidate will perform and direct laboratory and project activities, mentor and develop scientific personnel, and translate complex process and analytical data into clear development decisions. They will conceive, execute, and communicate multidisciplinary strategies that advance project and organizational goals, while serving as a senior PAT subject matter expert across multiple programs and initiatives.

A critical element of the role is strong integration with Analytical R&D project leads and cross-functional partners, particularly Process Engineering, Process Chemistry, Drug Product Development, manufacturing, Quality Assurance, CMC Regulatory, data science, and information technology. The scientist will define practical engagement models that bring PAT expertise into project planning at the appropriate stage and connect PAT outputs to process development, control strategy, validation, and technology-transfer decisions.

**Responsibilities:**

- Mentor, supervise, and develop a small team of PAT scientists; set priorities, allocate work, provide technical coaching, and ensure effective delivery across multiple development programs while also personally performing hands-on laboratory work.
- Create and maintain an integrated PAT strategy for synthetic molecule drug substance and drug product programs, including clear decision criteria for when and how PAT should be applied across the development lifecycle.
- Establish an effective operating model between PAT experts and Analytical R&D project leads, ensuring early engagement, aligned work packages, clear ownership, and timely translation of PAT results into project decisions.
- Lead PAT feasibility assessments, method and model development, robustness studies, validation, lifecycle management, and technology transfer for in-line, on-line, at-line, and off-line applications.
- Apply chemometrics and multivariate data analysis to develop, challenge, interpret, and maintain quantitative and qualitative models. Ensure models are scientifically sound, appropriately validated, and suitable for their intended use.
- Provide expert leadership in spectroscopic and process analytical techniques such as NIR, Raman, mid-IR/FTIR, UV-visible spectroscopy, particle and material-property measurements, and complementary process sensors.
- Lead or support deployment of on-line liquid chromatography for reaction monitoring, process consistency, impurity or product-quality measurements, and other fit-for-purpose drug substance or drug product applications.
- Integrate PAT measurements with process knowledge, critical process parameters, critical material attributes, and critical quality attributes to support process understanding and analytical control strategy development.
- Partner closely with Process Engineering, Process Chemistry, Drug Product Development, manufacturing, Quality, Regulatory, automation, data science, and IT teams to design interfaces, data flows, system readiness, and sustainable implementation approaches.
- Design material-sparing and risk-based development approaches where appropriate, troubleshoot complex sampling, interface, instrumentation, data-quality, and model-performance issues, and identify practical mitigations.
- Communicate PAT strategy, scientific rationale, risks, and recommendations to technical teams and senior stakeholders through clear written documents, presentations, and decision-focused discussions.
- Generate new scientific proposals, evaluate emerging PAT and digital technologies, and champion innovations that improve development speed, scientific understanding, robustness, and operational efficiency.
- Ensure work complies with applicable safety, quality, data-integrity, regulatory, and AbbVie requirements.

Qualifications

- Bachelor's, Master's, or Ph.D. in Analytical Chemistry, Chemical Engineering, Pharmaceutical Sciences, Chemometrics, or a closely related discipline, typically with a minimum of 14 years (BS), 12 years (MS), or 6 years (Ph.D.) of relevant industry experience.
- Demonstrated expertise in Process Analytical Technology within the pharmaceutical industry, including leadership of PAT strategy and method development across the development lifecycle.
- Strong hands-on experience with chemometrics, multivariate calibration, classification, experimental design, model validation, and model lifecycle management. Experience with software such as Unscrambler, PLS\_Toolbox, SIMCA, MATLAB, Python, R, or other chemometric and data-analysis platforms is expected.
- Demonstrated experience developing and applying PAT in both drug substance and drug product environments. Experience across batch and continuous manufacturing is desirable.
- Experience with spectroscopic PAT method development, sampling-interface design, process monitoring, and transfer or implementation in a manufacturing environment.
- Experience developing, deploying, or supporting on-line UHPLC applications as part of a process monitoring or control strategy.
- Demonstrated ability to lead a small scientific team through planning, execution, prioritization, coaching, and delivery of technically complex work.
- Proven ability to build alignment and work effectively across Process Engineering, Process Chemistry, Drug Product Development, manufacturing, Quality, Regulatory, data science, automation, and IT organizations.
- Working knowledge of pharmaceutical development, analytical control strategies, validation, technology transfer, data integrity, and relevant regulatory expectations for PAT applications.
- Excellent scientific problem-solving, technical writing, oral communication, and stakeholder-management skills, with the ability to convert complex data into clear recommendations and decisions.
- Ability to independently identify opportunities, adjust strategy as data emerge, and champion new technologies that advance project and organizational goals.

**Preferred Qualifications:**

- Experience applying PAT to biologics or new modalities, including oligonucleotides, lipid nanoparticles (LNPs), therapeutic peptides, or related complex products.
- Experience with PAT data-management systems, automation, advanced process control, or real-time release testing concepts.
- Experience authoring or contributing to PAT validation protocols, method procedures, technical reports, regulatory documentation, and manufacturing technology-transfer packages.

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 I, Novel Therapeutics

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](<https://www.abbvie.co.uk/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube](<https://www.youtube.com/user/AbbVie>).

Job Description

- Principal Research Scientist I, Novel Therapeutics
- Oxford, United Kingdom
- Full-time (onsite)

At DJS-AbbVie, we are advancing novel therapeutics and translating immunological science into innovative R&D programmes with the potential to make a meaningful difference for patients. As a UK-based discovery hub within AbbVie Immunology, we combine the focus and agility of a specialist team with the resources and ambition of a global pharmaceutical company.

We are now entering an exciting phase of team growth and scientific progression in Oxford. To support this next stage, we are seeking an experienced and highly capable drug hunter to join us as **Principal Research Scientist I** within our existing **Novel Therapeutics - Cellular Depletion Team**.

This role offers the opportunity to contribute to work that is scientifically ambitious, strategically important, and directly connected to patient impact. You will help shape programmes that aim to deplete pathogenic cells and enable long-term disease modification, while working in an environment that values scientific ownership, deep expertise, and collaborative problem-solving.

**Why this role?**

*Autonomy*

In this role, you will have significant scope to shape scientific strategy, influence portfolio direction, and act as molecule lead on selected programmes where appropriate. You will work closely with the team leader and cross-functional partners to define approaches, assess risk, and guide experimental plans. We are looking for someone who is confident taking ownership of complex scientific challenges and who thrives when given the freedom to lead with rigour and initiative.

*Mastery*

This role is ideal for a scientist who wants to deepen and apply expertise in drug discovery and immunology focusing on cellular depletion via any available modalities. You will have the opportunity to tackle challenging discovery questions and complex protein designs, contribute original ideas and champion innovative methods ultimately enhancing the scientific capability within the team. You will also mentor colleagues, share knowledge, and help develop a strong drug discovery mindset across the function.

*Purpose*

Our work is driven by the goal of delivering better outcomes for patients with serious and challenging diseases. In this role, you will help advance novel therapeutics with the potential to achieve durable disease improvement beyond symptomatic treatment. Your contributions will support programme progression from concept to candidate nomination, influence translational strategy, and help shape the future of our discovery portfolio.

**Successful applicant's key responsibilities**

- Where appropriate act as molecule lead on pipeline programmes, providing technical expertise and cross-functional leadership as teams form around assets
- Together with the team leader develop and deliver drug discovery strategy in alignment with AbbVie’s overall immunology strategy
- Serve as a key lab focused scientist at the DJS-AbbVie Oxford site, and ultimately act as a recognised scientific expert within the wider AbbVie R&D organisation in your specialist mechanism of action
- Collaborate with colleagues across immunology discovery research, development sciences, clinical development, and precision medicine
- Ensure high-quality project planning through sound experimental design, early risk assessment and robust contingency planning
- Identify and evaluate emerging scientific trends and translate relevant insights into functional objectives
- Apply imagination and innovation to create and implement new or improved approaches and breakthrough ideas
- Proactively share knowledge to build scientific capability within the team and foster a strong drug discovery mindset
- Mentor junior colleagues and support their scientific development
- Present scientific concepts and results to scientific and non-scientific audiences, including senior stakeholders and external partners

Qualifications

**Applicant’s essential attributes**

- Demonstrated experience across multiple drug discovery programs with at least one proven example of a cell depletion modality
- Education - BS, MS or PhD or equivalent experience in a relevant scientific area
- Demonstrated ability to function as a principal investigator, generating original technical ideas and development strategies
- Creative and practical problem-solving skills, with the ability to champion new technologies
- Recognised as an expert in your discipline, internally and ideally externally
- Strong publication, presentation, regulatory and/or patent record
- Excellent scientific communication and presentation skills, including experience presenting at leading scientific conferences

**Applicant’s desired attributes**

- Recognised expert in using cellular therapies e.g. CAR-T, CAR-NK, CAR-Treg, etc.
- OR recognised expert in complex antibody engineering including bispecific and novel formats
- Strong background in translational biology

**About DJS AbbVie**

DJS-AbbVie is part of AbbVie Immunology and is focused on advancing novel therapeutics to address serious and challenging diseases. Our work is driven by scientific excellence, collaboration and a commitment to delivering meaningful impact for patients.

Working at DJS-AbbVie offers the opportunity to join a dynamic and ambitious team, with exposure to a broad range of scientific challenges, close collaboration with experts across the wider organisation, and the chance to help shape the future of our discovery portfolio.

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 II – Psychiatry Drug Discovery

Company Description

**About AbbVie**

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

Job Description

**Overview**

We are seeking an experienced and highly motivated neuroscientist with strong drug discovery expertise to join our Discovery Psychiatry team. The successful candidate will apply drug discovery principles into exploratory through late-stage discovery programs and integrate knowledge across in vitro and in vivo electrophysiological approaches. Candidate must have a strong understanding of neural circuits, multimodal neurophysiological methodologies and translational utility. This role is an exciting opportunity to support psychiatry research from target validation, compound profiling, through clinical development in a dynamic, collaborative drug discovery environment.

**Key Responsibilities**

- Establish Drug Discovery framework in Psychiatry portfolio

- Contribute to the development and implementation of research workflows that integrate complex multimodal datasets

- Ensure alignment of development and discovery with broader cross-functional program team goals

- Support strategic decision-making in psychiatry drug discovery

- Provide scientific guidance and mentoring to junior scientists and research associates

Qualifications

- Bachelor’s Degree in Science related field with 16 years of related work; Master’s Degree Science or PharmD with 14 years of related work; PhD in Science or related field with 8 years of related work experience.
- Industry experience within early discovery for Psychiatry
- Demonstrated experience with neurophysiology and/or functional approaches, including experience in the design and execution of studies investigating synaptic and circuit modulation relevant to psychiatric indications
- Strong ability to work in cross-functional teams and effectively communicate scientific findings to both technical and non-technical audiences

**Desired Qualifications**

- Experience building translational frameworks or predictive approaches for functional biology data

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>)

Massachusetts

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>)

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>)

Regulatory Affairs 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

**PRIMARY FUNCTION/OBJECTIVE**

The position is to handle preparation of regulatory submissions in order to obtain and maintain marketing approvals of company products, to provide advice on regulatory matters to staff and customers and design RA strategy and lead cross functional meeting.

**RESPONSIBILITIES**

- Independently manage registration of new products and variations to marketed products (including medical devices) to ensure regulatory approvals are achieved in accordance with company objectives.
- Ensure new product registrations including BSE submissions and approval maintenance is conducted in a timely manner according to the registration plan.
- Coordinate responses to deficiency letters and other requests for data from regulatory authorities for products and ensure it meets agreed or required timelines.
- Liaise with officials of government agencies to facilitate evaluation processes and respond to requests for data in agreed timelines.
- Update product labeling in a timely manner based on the update of the product labeling from headquarters
- Review labeling and product information to ensure compliance with relevant regulations and codes.
- Generate registration plans and provide regular status reports.
- Report progress and status to manager and management as required including to corporate RA and NPI meetings.
- Design RA strategy and lead cross functional meetings.
- Independently manage development projects, including early pipeline products, from RA perspective.
- Communicate regulatory issues and evaluate the impact on the business to RA director, senior management, Business Unit and GM where applicable.
- Maintain good knowledge of relevant corporate policies and local regulations and ensure compliance.
- Keep abreast of regulatory changes and evaluate the impacts on the business and communicate changes in a timely manner to related parties and management.
- Update RA SOPs when regulations and processes are updated and review them to ensure they are within the validity timeframe.
- Participate in RA process and streamline processes to increase productivity.
- Lead the team in the management of the regulatory projects
- Manage the performance of team members
- Other regulatory projects and tasks assigned by RA Director.

Qualifications

- University degree in Pharmacy, Pharmacology, Biology or related disciplines
- About 8 years’ experience and in-depth knowledge of Taiwan Regulatory in Medical Device or Pharmaceutical Industry. New drug applications for NCE and clinical drug development knowledge will be an added advantage.
- Strong communications and coordination skills
- Proficiency in communicating strategic and tactical issues to management
- Proven interpersonal skills
- Excellent oral, written and good computer communication skills, including fluent English.

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, Respiratory Discovery Disease Team (DDT) Lead, Immunology Discovery Research

Company Description

**About AbbVie**

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

Job Description

**Overview**

As the scientific thought leader for AbbVie's Respiratory Discovery Research team, the Director, Respiratory Discovery Disease Team (DDT) Lead is tasked with building a vision and team to develop translational immunology insights to drive an exemplary pipeline for the Respiratory disease area. The Director is responsible for defining and implementing a cross-functional strategy aimed at breaking efficacy ceilings for Asthma and COPD. This work involves close collaboration with functions such as Business Development, Precision Medicine, Clinical Development, and Commercial. Under the Director's scientific vision and leadership, the Respiratory Discovery team is expected to generate compelling, data-driven rationales, including developing disease-relevant human complex in vitro models, that support the central role of target pathways. The team aims to build data packages that support the portfolio advancement of innovative molecules into First-In-Human (FIH) studies in respiratory diseases.

Beyond leading the Respiratory Discovery team and driving the development of a Respiratory pipeline and strategy, the Director is broadly responsible for Immunology Discovery Research. The Respiratory Discovery team is responsible for delivering key data to projects across all phases of drug discovery and utilizing different modalities, such as small molecules, biologic molecules, peptides, and genetic medicine therapies.

This leadership position requires a deep understanding of immunology, with a focus on lung biology, in vivo and complex in vitro model systems, and pharmacology.

**Responsibilities**

- In this role, the Director acts as both a program and people leader, focusing on supporting key portfolio program milestones, driving the identification of novel targets through partnerships with multiple functional teams and external collaborators, promoting technical excellence in Respiratory Discovery Research, and contributing to the strategic direction of the Respiratory DDT.
- The role involves leading and implementing drug discovery pipeline programs and evaluating and integrating external programs and academic collaborations into the pipeline, aligning with strategic core respiratory disease areas, with a potential extension into IPF.
- The individual will attract and lead a multidisciplinary team of approximately 15+ world-class scientists based at the Cambridge, MA research site.
- Additionally, they will leverage a global network within the research community to establish and direct multiple research collaborations with leading academic and biotech laboratories.
- This individual will join the Immunology DDT Leadership Team, sharing accountability for the success of the Immunology Pipeline at AbbVie.
- They will also provide scientific insights that advance compelling opportunities through the pipeline, including accessing appropriate cellular and animal models, selecting optimal translational strategies, and introducing new technologies.
- The individual will advise on and share accountability for transitions across major drug discovery and development milestones, evaluate the scientific merits of potential biotechnology alliances, extract value from AbbVie's participation in public-private consortia, consider and evaluate both internal pipeline and external licensing opportunities, and guide AbbVie's research alliances and collaboration efforts across defined areas of diseases.

Qualifications

- MD/PhD, PhD or MS in related field
- ~12+ years of experience in Immunology Drug Discovery with specific research interests focused on chronic inflammatory and autoimmune diseases in the Respiratory area.
- Demonstrated passion and drive to translate molecular genotyping and phenotyping into pathway and target identification and validation using various pharmacological approaches
- Prior pharmaceutical/biotech industry experience including the advancement of innovative new approaches to early development is required
- Track record of impacting disease understanding and portfolio through implementation of innovative disease model approaches
- An extensive network of connections with leading investigators in the global science field actively supporting open exchange of expert opinions and visions of technology.
- Track record of attracting, retaining and developing talent with previous extensive people leadership experience
- Excellent communication and interpersonal skills. Experience in interacting with executive-level management
- The ability to achieve results in accordance with a research plan and timelines without formal authority in a cross-disciplinary academic/industrial 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>)

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>)

Senior Principal Research Scientist 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>)

R&D Process Engineering Organization, a part of AbbVie’s Development Sciences organization, is responsible for designing and developing scalable processes to make drug substances and drug products, including synthetics molecules, antibody drug conjugates (ADCs) and genetic medicines, 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). It drives the development of innovative engineering technologies and creates valuable intellectual property through the composition of matter and chemical/bio-chemical processes resulting in cost-effective commercial manufacturing processes for quality products. Process Engineering organization also supports the scale-up in the pilot plants and supply chain development for pipeline molecules and supports the justification of CMC regulatory content.

Job Description

**Role Overview**

The successful Process Engineering candidate will play a key technical team leader role in the R&D Process Engineering function. In addition to a strong background in fundamentals of chemical engineering, the ideal candidate will have demonstrated experience in the biologics, peptides, ADC development and genetic medicines as a strong technical team leader. The candidate must have demonstrated initiative in building and sustaining cross-functional collaborations. In addition to leading the technical team, the successful candidate is also expected to lead the identification and development of novel approaches and technologies to enhance process development efficiency and commercialization of novel modalities. The candidate must exhibit a collaborative behavior in proactively identifying process challenges on a wide range of pipeline and innovation projects, take a leadership role in a cross-functional team to deliver specific project needs, and take on a scientific leadership role in developing and implementing solutions.

**Key Responsibilities:**

- Develop robust manufacturing processes, supporting assets including novel modalities through all phases of clinical development.
- Lead project teams towards process development and characterization of new synthetic and large molecule assets.
- Influence process development of toxins, cosmetic active ingredients and genetic medicines proactively.
- Lead scale-up of laboratory processes in the pilot plant.
- Set project strategies, define project responsibilities and timelines, and provide leadership in a matrixed team setting.
- Address challenging problems with biochemical reactions, separations, and/or isolations using expertise in reaction kinetics, transport phenomena, and mathematical modeling.
- Establish, communicate, and execute research plans.
- 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 and/or review technical documents summarizing process development efforts and contribute to regulatory filings.
- Strengthen scientific brand of Process Engineering while providing mentorship to direct reports and process engineering colleagues.

Qualifications

- BS, MS, or PhD in Chemical/Bio Engineering or a related field and 18+ (BS), 16+ (MS), or 10+ (PhD) years of relevant biopharmaceuticals industrial experience.
- Ph.D. candidates with pertinent research exposure are also encouraged to apply.
- Job level will be commensurate with academic and/or industrial work experience.
- Candidates are expected to have a strong foundations in chemical engineering and the proven ability to demonstrate their skills in this field.
- The candidate is expected to demonstrate the ability to solve challenging technical problems and champion next generation of innovative technologies to achieve project goals around novel modalities.
- The candidate is required to be a strong team player and demonstrate scientific leadership, possessing effective oral and written communication skills for facilitating co-creation and leading cross-functional process development 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 postingbased 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 orless than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.

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

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 Statement**

As a recognized scientific leader in preclinical pharmacokinetics, provides scientific, operational, and people leadership for the US Pharmacokinetics Team within Quantitative, Translational and ADME Sciences (QTAS). Leads the development and execution of strategies that support discovery and development programs through high-quality pharmacokinetic and toxicokinetic study design, analysis, reporting, and scientific consultation. Drives functional excellence through innovation, operational improvements, capability development, and talent growth while ensuring effective support of AbbVie's pipeline priorities.

**Major Responsibilities**

- Lead and develop the Pharmacokinetics Team, including performance management, coaching, recruitment, succession planning, and employee development.

- Establish strategic direction and operational priorities for the Pharmacokinetics organization to support current and future portfolio needs.

- Provide scientific leadership and oversight for non-clinical pharmacokinetic and toxicokinetic study design, analysis, interpretation, and reporting.

- Serve as a pharmacokinetics subject matter expert supporting project teams across therapeutic areas and stages of drug discovery and development.

- Ensure delivery of high-quality PK/TK data packages, reports, and regulatory documentation supporting project progression and regulatory submissions.

- Drive operational excellence initiatives focused on workflow optimization, automation, scalability, and continuous improvement of PK support activities.

- Lead implementation of innovative technologies, data science approaches, visualization tools, and digital solutions that improve decision making and operational efficiency.

- Develop and maintain strong cross-functional partnerships with Discovery Sciences, Pharmaceutical Sciences, CMC, and Toxicology stakeholders.

- Champion animal welfare, compliance, and best scientific practices associated with preclinical pharmacokinetics activities.

- Represent the function to senior leadership and communicate priorities, resource requirements, risks, opportunities, and strategic recommendations.

Qualifications

**Required**

- Bachelor’s degree plus 16 years of experience, or master’s degree plus 14 years of experience, or PhD plus 8 years of experience in pharmacokinetics, pharmaceutics, pharmaceutical sciences, DMPK, toxicology, or a related scientific discipline.
- Typically, 10+ years of relevant pharmaceutical industry experience supporting drug discovery and development programs.
- Proven experience leading scientific teams and developing talent.
- Strong understanding of non-clinical study design, PK/TK analysis, interpretation, and reporting.
- Excellent communication, collaboration, and stakeholder management skills.

**Preferred**

- Demonstrated expertise in preclinical pharmacokinetics and toxicokinetics.
- Experience supporting regulatory submissions and cross-functional project teams.
- Demonstrated success driving organizational change and operational improvement initiatives.
- Experience implementing digital, automation, analytics, or data science solutions within a scientific organization.
- Experience leading complex cross-functional initiatives spanning multiple functions and therapeutic areas.
- Track record of building high-performing teams and developing future leaders.

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 Manager, Regulatory Affairs US Advertising and Promotion - Immunology - Hybrid

Company Description

**About AbbVie**

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

Job Description

The **Senior Manager Regulatory Affairs US Advertising and Promotion-Immunology** combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications of changing regulations and policies.

**Responsibilities:**

- Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVie’s interests. Maintains awareness of pending changes to communicate impact and relevance within Regulatory Operations. Drafts and finalizes comments in a timely manner, to regulators and trade associations. Distributes proposed policies to SMEs. Highlights key points in a clear and concise manner.
- Represents department and participates in trade associations as needed. Develops good working relationships with trade association managers.
- Summarizes findings, under supervision, in concise reports for distribution within AbbVie
- Oversee the operations productivity and development of assigned regulatory staff that are responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies. Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the FDA and cosmetic Act.
- Development and guides implementation strategies for promotional activities
- Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
- Ensure departmental training and compliance with established regulations, guidance, promotional guidelines and SOPs related to advertising and promotion regulations for self and direct reports. Manages direct reports and assists in the development, training and mentoring of staff members
- Effectively presents pertinent information to appropriate cross-functional groups.
- Effectively delivers difficult messages to commercial organizations without damage to relationships
- Establishes solid relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.) fostering mutually beneficial interactions and exchange.
- This role will work a hybrid work schedule (3 days in office & 2 days remotely) from one of the following AbbVie headquarters; Lake County, IL; Florham Park, NJ; Irvine, CA.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

- Minimum: Bachelor’s degree in science (biology, chemistry, microbiology immunology, medical technology, pharmacy, pharmacology, nursing, pharmacy) plus 7 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
- Preferred PharmD degree plus 5 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
- Experience working in a complex and matrix environment and exhibits strong negotiation skills
- Strong communication skills, both oral and written
- Experience in management capacity preferred
- Experience in US Regulatory Affairs Advertising and Promotion

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>)

California

Principal Research Scientist II, Computational Sciences, MPDD

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 Molecular Profiling and Drug Delivery (MPDD) function within the Synthetic Molecule CMC organization is accountable for a broad range of deliverables across multiple stages of drug discovery and development. From virtual screening, lead generation, and lead optimization through candidate selection, MPDD scientists use state-of-the-art automation and computational tools, supported by expertise in biopharmaceutics, drug delivery, and solid-state chemistry, to collaboratively design and advance candidates with a higher probability of success into development and to inform clinical drug-delivery strategy. From candidate selection through clinical proof of concept and product launch, MPDD scientists work on cross-functional teams to identify the commercial solid form of the active pharmaceutical ingredient (API) and establish structure–property–performance correlations that help deliver robust commercial processes and align control strategies across drug substance and drug product.

Computational chemists within AbbVie’s MPDD organization partner across Development Sciences and Discovery Sciences in three key focus areas: molecular design and profiling, chemical transitions, and materials design across synthetic modalities. Their work supports the design and advancement of compounds, materials, and formulations with optimal developability properties from lead optimization through commercial development, aligned with the broader goal of advancing first-in-class and best-in-class clinical candidates. The team develops hierarchical modeling approaches that integrate physics-based atomistic methods, including molecular dynamics and quantum mechanics, with machine learning, artificial intelligence, and hybrid physics-informed AI/ML models across hardware platforms for precision in predictions. In close collaboration with medicinal chemists, data scientists, materials scientists, formulation scientists, engineers, and molecular modelers, the team embeds these tools into screening funnels across medicinal chemistry design cycles and preclinical and clinical drug-substance and drug-product development, while maintaining a strong partnership ecosystem to source and leverage external innovation.

Job Description

AbbVie’s MPDD organization is seeking a highly motivated, talented, and creative scientific leader with deep expertise in computational chemistry for a Principal Scientist II position. This individual will help shape and advance the organization’s computational sciences vision in alignment with AbbVie’s broader R&D priorities and AI strategy. In this role, the successful candidate will collaboratively guide the identification, development, piloting, implementation, and eventual democratization of stage-appropriate computational models that leverage advanced computational techniques to enable the design and optimization of drug candidates across synthetic modalities. The ideal candidate will bring a strong record of project impact, capability development, and external partnership building across the mid- to late-stage discovery process, with expertise in quantum mechanics, atomistic molecular simulations, including molecular dynamics, and AI/machine learning. Prior experience mentoring early- and mid-career scientists in matrixed and/or direct-reporting relationships is also expected.

Responsibilities

- Partner with project teams across Discovery and Early Development to establish quantitative objectives for lead optimization and de-risking from candidate nomination through candidate selection.

- Provide scientific leadership in applying computational chemistry approaches to molecular design and profiling and, more broadly, to chemical transitions and materials design across synthetic modalities.

- Guide computational chemistry team members in designing and executing benchmarking studies to evaluate model performance, applicability, and limitations.

- Clearly communicate the rationale for selecting specific computational models and workflows, including their relevance to project objectives and stage-appropriate applications.

- Lead the development, implementation, and continuous improvement of a cohesive portfolio of internal computational models and workflows that address AbbVie’s small-molecule and synthetic-modality needs.

- Apply physics-based computational methods, including quantum mechanics and atomistic molecular simulations, as well as machine learning, artificial intelligence, and hybrid physics-informed AI/ML approaches to support drug discovery and development.

- Collaborate with medicinal chemists, data scientists, materials scientists, formulation scientists, engineers, molecular modelers, and other cross-functional partners to integrate computational tools into design and screening workflows.

- Proactively provide expert advice, technical guidance, and shared knowledge to direct reports, peers, project teams, and senior leaders.

- Identify emerging scientific trends from internal and external sources and incorporate relevant opportunities into functional objectives and longer-term computational sciences strategies.

- Lead or support the identification, development, piloting, implementation, and democratization of computational capabilities across appropriate discovery and development workflows.

- Present program updates, research strategies, and scientific recommendations to functional and cross-functional leaders, project teams, and external partners.

- Maintain awareness of emerging literature, technologies, and scientific advances in computational chemistry, data science, and AI/ML, and translate relevant developments into actionable research opportunities.

- Prepare and deliver concise scientific presentations, publications, conference abstracts, and other scientific disclosures within and outside AbbVie.

- Build and maintain strong relationships with external collaborators and partners to source, evaluate, and leverage external innovation.

- Participate in internal and external initiatives and working groups to influence scientific thinking, approaches, and standards in computational medicinal chemistry.

- Ensure compliance with all applicable AbbVie policies and procedures.

Qualifications

Qualifications

- Bachelor’s degree or equivalent education in chemistry, computational chemistry, pharmaceutical sciences, chemical engineering, computer science, or a related scientific field, with typically 16+ years of related work experience; Master’s degree or equivalent education, with typically 14+ years of related work experience; or a PhD in chemistry, computational chemistry, pharmaceutical sciences, chemical engineering, computer science, or a related field, with typically 8+ years of related work experience.

- Extensive knowledge and experience applying computational chemistry and data science approaches to medicinal chemistry, drug discovery, and molecular optimization.

- Extensive knowledge and experience with modern computational methods, including quantum mechanics, molecular dynamics, atomistic molecular simulations, machine learning, artificial intelligence, and/or hybrid physics-informed AI/ML approaches.

- Demonstrated experience developing, evaluating, and applying computational models and workflows across multiple stages of the drug discovery and development process.

- Experience establishing model performance benchmarks, defining domains of applicability, and communicating model limitations and appropriate use to multidisciplinary project teams.

- Demonstrated ability to translate complex computational concepts and scientific results into clear, actionable recommendations for technical and nontechnical audiences.

- Experience leading multiple complex research programs, initiatives, or capability-development activities in a matrixed and/or direct-reporting environment.

- Demonstrated experience mentoring and developing early- and mid-career scientists and fostering a collaborative, inclusive, and innovative team environment.

- Strong analytical and problem-solving skills, with the ability to think critically and creatively and develop solutions independently and collaboratively with internal and external experts.

- Highly organized, self-directed, and able to prioritize resources and deliver results across multiple simultaneous programs.

- Demonstrated ability to identify emerging technologies, assess their potential value, and guide their adoption to achieve project and functional objectives.

- Strong written and verbal communication skills, including experience presenting scientific strategies and results to senior leaders, cross-functional teams, and external partners.

- A record of scientific contributions through publications, conference presentations, abstracts, patents, or other appropriate scientific disclosures is preferred.

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 Scientist I, Biologics Analytical Research and 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

**About the Team**

AbbVie Biologics Analytical Research & Development (Biologics ARD) is a global analytical sciences organization responsible for CMC analytical development of AbbVie's pipeline of innovative therapeutic biologic products. We are a world-class team of scientists and leaders united by a shared mission to advance industry-leading analytical capabilities and meaningfully contribute to the advancement of AbbVie’s pipeline of innovative medicines.

The Biologics ARD team at the AbbVie Bay Area site in South San Francisco has a long and rich history of biologics development. Located in a state-of-the-art facility housing end-to-end CMC development capabilities, the team works collaboratively to advance novel biologic therapeutics – including multi-specifics, ADCs, antibodies, and novel modalities – into first-in-human clinical development and through to clinical proof of concept. Careers in AbbVie Biologics ARD provide unique opportunities to work with cross-functional and global teams to drive exceptional science and innovative product development strategies.

**Role Summary**

We are seeking a highly skilled and motivated analytical scientist to join the Biologics CMC Analytical Research and Development team. This role provides scientific leadership in the development of advanced analytical methods to support biotherapeutic protein characterization, process understanding, and product development. The successful candidate will independently develop innovative approaches and apply state-of-the-art capillary electrophoresis and chromatographic methods, serve as an analytical lead on development teams, and contribute to regulatory strategy and scientific innovation. This position also includes supervisory responsibilities, including leading and mentoring one or more scientists and supporting their performance and development. The role operates within a cross-functional, on-site environment supporting a portfolio that includes multi-specifics, antibodies, ADCs, and novel modalities.

**Responsibilities**

- Independently develop state-of-the-art capillary electrophoresis and chromatographic methods to characterize biotherapeutic proteins and their associated variants and impurities.
- Generate new scientific proposals and develop innovative approaches to solve difficult analytical challenges.
- Represent the Biologics CMC Analytical Research and Development Group as Analytical Lead on CMC development teams and a subject matter expert on cross functional project teams.
- Supervise a team of one or more scientists and be accountable for the effective performance of the team.
- Develop/optimize, qualify/validate, and transfer fit-for-purpose QC release and stability methods. Provide technical support and oversight for QC testing occurring at internal and external GMP laboratories.
- Plan, author, and review regulatory submission documents, responses to health authority queries, technical reports, lab data, and method qualification/validation protocols.
- Engage and influence the broader scientific community through publications and poster and oral presentations at industry conferences.

Qualifications

- Degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field. PhD with 6+ years, MS with 12+ years, or BS with 14+ years of relevant industry experience.
- Must possess a solid understanding of protein chemistry and biochemistry, particularly as it relates to biotherapeutic protein drug development.

- Demonstrated expertise in analytical method development for biologics, with strong hands-on experience in capillary electrophoresis and HPLC.
- Experience supporting biologics CMC development, QC method qualification/validation, and method transfer.
- Proven ability to interpret complex data, solve technical problems, and propose innovative scientific solutions.
- Experience contributing to regulatory submissions, including quality and characterization sections, and responding to health authority questions.
- Strong leadership, communication, and collaboration skills, with experience mentoring and supervising scientists.
- Track record of scientific publications and conference presentations preferred.

- Must be capable of working in a fast-paced, collaborative environment and managing multiple concurrent projects with a high degree of independence.

**Preferred Attributes**

- Deep understanding of biologics analytics, impurity profiling, and protein characterization.
- Ability to work effectively across functions and influence scientific and technical decisions.
- Strong organizational skills and the ability to manage multiple priorities in a fast-paced environment.
- Commitment to scientific excellence, quality, and continuous improvement.

*This is a full-time, on-site role located in South San Francisco, CA. The position requires daily in-person collaboration across scientific and cross-functional teams. Candidates should expect frequent interaction with both local and global colleagues.*

**Compensation & Leveling**

Compensation and Leveling will be commensurate with experience.

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>)

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

Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging advanced capabilities to drive industry leading performance.

Partners with study teams, AbbVie internal R&D stakeholders, investigators, and site staff for meaningful and effective engagements positioning AbbVie as the partner of choice in clinical trials.

Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.

Responsibilities

- "Considered as the Pprimary Sponsor pPoint of contact for the investigative site. Advanced level of competency or experience in providing contextual information on the clinical trials, connecting stakeholders to the investigative sites and strengthening Abbvie's positioning.
  Ability to motivate and align monitoring community through leadership and mentorship."
- Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol, and patient treatment principles for the trial ensuring a trusted partnership. Able to support, guide, and mentor junior personnel on Site Management activities.
- "Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.
- Superior understanding of site engagement and ability to customize site engagement strategy for assigned study/ies and critically apply new strategies as needed. Gather local/site insights and utilize site engagement tools to report/track progress and measure impact of that strategy.
- Superior level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Expert understanding to generate and ensure effective recruitment and retention techniques/plans based on the patient disease journey.
  Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance."
- Possesses advanced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. Supports local onboarding of more junior CRAs. Demonstrates ability to openly listen to and consider viewpoints to enhance outcomes.
- May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager.
  "
- Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. Superior ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a cust
- Independently Identifies, evaluates and recommends new/potential investigators/sites on an on going basis demonstrating expert understanding and decision making. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
- Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. Ensures audit and regulatory inspection readiness at assigned clinical site at all times. Manages investigator payments as per executed contract obligations, as applicable.

Qualifications

- Appropriate tertiary qualification in health related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred.
- Minimum of 3 years of clinically related experience, of which a period of 2 years is preferable in independent clinical research monitoring of investigational drug or device trials in any therapeutic area. Familiar with risk‐based monitoring approach, onsite and offsite monitoring.
- Knowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials
- Superior knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
- Demonstrate advanced communication skills and superior cross-functional collaboration skills among internal and external stakeholders.
- Demonstrate superior planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
- Superior ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.
- Superior interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.
- Ability to independently use functional expertise, leverage critical thinking skills and apply good judgement to address clinical site issues
- Acts with integrity in accordance with AbbVie code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.

Additional Information

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

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

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

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

Senior Manager Regulatory Affairs US Advertising and Promotion

Company Description

**About AbbVie**

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

Job Description

The **Senior Manager Regulatory Affairs US Advertising and Promotion** combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications of changing regulations and policies.

**Responsibilities:**

- Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVie’s interests. Maintains awareness of pending changes to communicate impact and relevance within Regulatory Operations. Drafts and finalizes comments in a timely manner, to regulators and trade associations. Distributes proposed policies to SMEs. Highlights key points in a clear and concise manner.
- Represents department and participates in trade associations as needed. Develops good working relationships with trade association managers.
- Summarizes findings, under supervision, in concise reports for distribution within AbbVie
- Oversee the operations productivity and development of assigned regulatory staff that are responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies. Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the FDA and cosmetic Act.
- Development and guides implementation strategies for promotional activities
- Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
- Ensure departmental training and compliance with established regulations, guidance, promotional guidelines and SOPs related to advertising and promotion regulations for self and direct reports. Manages direct reports and assists in the development, training and mentoring of staff members
- Effectively presents pertinent information to appropriate cross-functional groups.
- Effectively delivers difficult messages to commercial organizations without damage to relationships
- Establishes solid relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.) fostering mutually beneficial interactions and exchange.
- This role will work a hybrid work schedule (3 days in office & 2 days remotely) from one of the following AbbVie headquarters; Lake County, IL; Florham Park, NJ; Irvine, CA
- Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

- Minimum: Bachelor’s degree in science (biology, chemistry, microbiology immunology, medical technology, pharmacy, pharmacology, nursing, pharmacy) plus 7 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
- Preferred PharmD degree plus 5 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
- Experience working in a complex and matrix environment and exhibits strong negotiation skills
- Strong communication skills, both oral and written
- Experience in management capacity preferred
- Experience in US Regulatory Affairs Advertising and Promotion

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>)

Company Description

**About AbbVie**

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

Job Description

**PRIMARY FUNCTION/OBJECTIVE**

Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging advanced capabilities to drive industry leading performance. Partners with study teams, AbbVie internal R&D stakeholders, investigators, and site staff for meaningful and effective engagements positioning AbbVie as the partner of choice in clinical trials. Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.

**CORE JOB RESPONSIBILITIES**

- Considered as the Primary Sponsor Point of contact for the investigative site.
- Advanced level of competency or experience in providing contextual information on the clinical trials, connecting stakeholders to the investigative sites and strengthening Abbvie positioning.
- Ability to motivate and align monitoring community through leadership and mentorship.
- Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol, and patient treatment principles for the trial ensuring a trusted partnership.
- Able to support, guide, and mentor junior personnel on Site Management activities.
- Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protectionㅍof study subjects.
- Superior understanding of site engagement and ability to customize site engagement strategy for assigned study/ies and critically apply new strategies as needed. Gather local/site insights and utilize site engagement tools to report/track progress and measure impact of that strategy.
- Superior level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities.
- Expert understanding to generate and ensure effective recruitment and retention techniques/plans based on the patient’s disease journey.
- Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
- Possesses advanced level of competency to mentor and train less experienced CRAs on various aspects of work and provides in put into their development. Supports local onboarding of more junior CRAs.
- Demonstrates ability to openly listen to and consider viewpoints to enhance outcomes.
- May participate/lead in global/local task forces and initiatives.
- Responsible for activities assigned by manager.
- Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
- Superior ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution.
- Ensure preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a Cust Independently Identifies, evaluates and recommends new/potential investigators/sites on an on going basis demonstrating expert understanding and decision making.
- Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
- Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
- Ensures audit and regulatory inspection readiness at assigned clinical site at all times.
- Manages investigator payments as per executed contract obligations, as applicable.

Qualifications

- Appropriate tertiary qualification in health-related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred.
- **Minimum of 3 years of clinically related experience**, of which a period of **2 years is preferable in independent clinical research monitoring** of investigational drug or device trials in any therapeutic area.
- Familiar with **risk‐based monitoring approach**, **onsite and offsite monitoring**.
- Knowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
- Superior knowledge on existing and emerging **local regulatory** and **legal requirements, ICH/GCP Guidelines** and **applicable policies**.
- Demonstrate **advanced communication skills** and superior **cross-functional collaboration** skills among internal and external stakeholders.
- Demonstrate superior planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
- Superior ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.
- Superior interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.
- Ability to **independently** use functional expertise, leverage critical thinking skills and apply good judgement to address clinical site issues
- Acts with integrity in accordance with AbbVie code of business conduct and leadership values.
- Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.

Additional Information

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

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

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

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