Senior Director and Section Head of Clinical Pharmacology & Pharmacometrics

Role Summary

The Senior Director and Section Head of Clinical Pharmacology & Pharmacometrics leads a team of clinical pharmacologists providing scientific leadership and execution of clinical development plans from Phase 1-Phase 4 programs. This includes prediction and characterization of the pharmacokinetics, pharmacodynamics, and efficacy of drug candidates into a Model-Informed Drug Development framework. The role focuses on people leadership, mentorship, and cross-functional collaboration to ensure optimal leadership from clinical pharmacology and pharmacometrics across Biogen programs.

Responsibilities

• Leads and manages high-profile clinical pharmacology activities including training, CDP and study designs across drug modalities and Biogen disease areas
• Leads clinical pharmacology efforts in early and late-stage programs (e.g., study design, protocol concepts, clinical phase oversight, data analysis, and reporting) to yield high-value PK/PD insights; analyzes results and recommends actions
• Represents clinical pharmacology at governance bodies (DPAC, RDGC, TRC) and external advisory boards
• Provides regulatory strategy expertise for drug filings and is responsible for Clinical Pharmacology sections of regulatory documents; maintains knowledge of regulatory practices and drug development precedent
• Engages in cross-functional activities, providing Clinical Pharmacology input and acting as a resource to other functions; participates in cross-functional committees
• Maintains scientific presence in Clinical Pharmacology through publications, posters, and conference presentations; engages with consultants and the scientific community
• Manages and/or mentors staff; develops expertise in specialized aspects of Clinical Pharmacology and serves as a reference source for peers

Qualifications

• Ph.D., M.D./Ph.D., or Pharm.D. in Clinical Pharmacology, pharmacokinetics, or a related field
• 15+ years of direct industry experience in Clinical Pharmacology
• Demonstrated experience in leading teams and/or managing professional staff
• Internationally recognized expert in Quantitative Clinical Pharmacology
• Experience developing Clinical Pharmacology strategy and designing/implementing Clinical Pharmacology studies
• Strong knowledge of the drug development process and regulatory familiarity; experience preparing regulatory submissions and responding to health authority questions
• Extensive record of publications, presentations, and scientific activities
• Active knowledge of advanced methods for Quantitative Pharmacology and PMx analyses
• Experience with PK/PD software such as Phoenix WinNonlin, SimCYP, NONMEM, Monolix, R, Adapt, MATLAB, SAS

Skills

• Strong leadership and people-management abilities
• Excellent collaboration and cross-functional communication
• Strategic thinking with ability to translate data into actionable decisions
• Excellent scientific writing and presentation skills