Head of Clinical Pharmacology & Pharmacometrics, West Coast Hub
About The Position
As the Head of Clinical Pharmacology & Pharmacometrics for the West Coast Hub (WCH), you will spearhead the strategic oversight and integration of Clinical Pharmacology and Pharmacometrics across our development portfolio. This pivotal role provides senior scientific leadership, ensuring strategies are scientifically rigorous, internally aligned, and regulatorily defensible. You will navigate early development, late-stage, and registrational programs, focusing on BLAs, subcutaneous bridging strategies, lifecycle management, and indication expansion. As a key member of the WCH Extended Development Leadership Team, you will collaborate with Clinical Development, Regulatory, Biomarkers, Biometrics, and Clinical Operations to guide portfolio strategy and decision-making. Your leadership will be crucial in maintaining scientific quality and consistency, influencing the development strategy, and optimizing development paths within the organization.
Requirements
- PhD, PharmD, MD, or equivalent advanced degree in Clinical Pharmacology, Pharmacometrics, or a related discipline.
- 15+ years of progressive leadership experience in Clinical Pharmacology and Pharmacometrics across early through late‑stage development, including registrational programs and BLAs, with substantial industry experience.
- Demonstrated success as a senior scientific and people leader in complex, matrixed R&D organizations.
- Deep expertise in Model Informed Drug Development (MIDD), exposure–response analysis, biologics development, and regulatory strategy.
- Strong understanding of global regulatory expectations for late-stage development and submissions.
- Proven ability to operate at a portfolio and governance level, influencing strategy without direct execution.
- Strong collaboration and influence skills across cross-functional development leadership teams.
Nice To Haves
- Experience representing organizations through scientific publications and conference presentations.
- Demonstrated ability to build, lead, and mentor high-performing teams.
Responsibilities
- Define and lead the integrated Clinical Pharmacology and Pharmacometrics strategy across the WCH portfolio, aligned with therapeutic area strategy, development objectives, and enterprise standards.
- Maintain accountability for scientific quality, consistency, and regulatory readiness, proactively identifying and mitigating scientific, regulatory, and execution risks.
- Provide oversight of Clinical Pharmacology and Pharmacometrics across early development through registrational programs, including dose selection and optimization, subcutaneous bridging, BLAs, label expansions, and lifecycle management—owning the integrated delivery and execution of these capabilities in alignment with broader clinical development, regulatory, device, PO&T, and commercial considerations.
- Deliver senior review, challenge, and alignment of dose justification strategies, exposure–response frameworks, quantitative pharmacology and pharmacometric modeling approaches, and Model‑Informed Drug Development (MIDD) strategies.
- Act as a member of the WCH Extended Development Leadership Team and Development Review Committee, integrating Clinical Pharmacology and Pharmacometrics perspectives into portfolio decisions and resolving cross‑program tradeoffs.
- Serve as the Clinical Pharmacology and Pharmacometrics thought leader for WCH programs, influencing development strategy and investment decisions.
- Champion the use of Model‑Informed Drug Development (MIDD) to accelerate decision‑making and optimize development paths.
- Build, lead, and mentor a high‑performing team of Clinical Pharmacology and Pharmacometrics leaders, including functional leads and matrixed contributors.
- Represent Biogen externally through scientific publications, conference presentations, and engagement with academic and industry experts.
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
Ph.D. or professional degree
