About This Role:
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.
What You’ll Do:
- 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.
Who You Are:
You are a visionary leader with a robust scientific acumen, ready to influence and drive strategic decisions in Clinical Pharmacology and Pharmacometrics. Your extensive experience enables you to navigate complex R&D environments with ease. You thrive in high accountability settings, seamlessly integrating cross-functional insights to enhance portfolio strategies. With a collaborative spirit, you are skilled at mentoring teams and fostering an environment of scientific excellence. Your commitment to advancing drug development through innovative methodologies and strategic foresight sets you apart as a leader in the field.
Required Skills:
- 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.
Preferred Skills:
- Experience representing organizations through scientific publications and conference presentations.
- Demonstrated ability to build, lead, and mentor high-performing teams.
