Associate Director, Clinical Pharmacology
AbbVie
Summary
Conceives, executes and effectively manages and communicates multi-disciplinary Clinical Pharmacology development plans and strategies that achieve commercial goals and regulatory requirements for multiple functions. Generates new PK/PD study proposals and leads those efforts. Anticipates and critically evaluates Clinical Pharmacology, PK/PD or regulatory advances, strengths, weaknesses, opportunities and threats, and responds with appropriate new strategies. Leads Clinical Pharmacology/PK/PD aspects of multiple projects. Responsible for critically evaluating technical and scientific aspects along with Clinical Pharmacology and Pharmacometrics management.
Job description
Responsibilities
- Accountable for Phase 1-4 studies design, and clinical pharmacology strategy; acts as the representative for project(s).
- Executes strategy, lead teams and various data analyses and interpretation by providing necessary context (including explaining MoA and disease specifics, available relevant internal and external data, analysis plans, interpretation and discussion of model results in the context of research question).
- Author regulatory documents including protocols, study reports, population PK reports, exposure-response analyses reports, CTDs, label sections, relevant section of investigator brochures, white papers, and other similar documents.
- Leads clinical pharmacology and biopharmaceutics meetings, serve as CLINICAL PHARMACOLOGY representative at Clinical Strategy Team/Asset Development Team and present at various departmental and cross functional teams such as study teams, CLINICAL PHARMACOLOGY leadership team, Journal club.
- Drives small teams with members from CLINICAL PHARMACOLOGY functional groups to provide a unified clinical pharmacology position to clinical, CMC and regulatory teams.
- Authors scientific publications and present at national and international conferences and interact with KOLs/external stakeholders.
- Conducts due diligence assessments, summarizes results and represents CLINICAL PHARMACOLOGY on business development teams.
- Represents Clinical Pharmacology at regulatory meetings.
Requirements
- PhD with typically 4+ years of experience in a relevant field, or PharmD with typically 6+ years of experience
- Master's Degree or equivalent education and typically 12+ years of experience
- Bachelor's Degree or equivalent education and typically 14+ years of experience
- Relevant field includes experience with PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters
- Excellent interpersonal skills
- Ability to interact with functional representatives and KOLs externally and internally and lead team(s)
- Strategic thinking and enterprise view
- Proven scientific track record and technical skills to perform the role
- Delivers business results while positioning for long-term success
- Persistent and resilient in moving good ideas forward
- Acts respectfully yet courageously
- Connects unrelated concepts, generates original or unique ideas
- Influences colleagues to achieve cross-functional alignment
- Gives and accepts full accountability when delegating
Benefits
- Paid time off
- Medical, Dental & Vision
- 401(k)
- Long-term incentive programs
Company overview
AbbVie is a global biopharmaceutical company that discovers, develops, and markets advanced therapies for some of the world's most complex and serious diseases. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie has established itself as a leader in immunology, oncology, neuroscience, eye care, and virology. The company's flagship product, Humira (adalimumab), was one of the world's top-selling drugs for treating autoimmune conditions like rheumatoid arthritis and Crohn's disease. AbbVie maintains a robust pipeline of innovative medicines and has expanded its portfolio through strategic acquisitions, including Allergan in 2020. With research facilities across the United States and globally, AbbVie focuses on advancing science to improve patient outcomes while maintaining strong commercial operations worldwide. The company operates with a patient-centric approach and invests significantly in research and development to address unmet medical needs across multiple therapeutic areas.