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, efficacy of drug candidates into a Model-Informed Drug Development (MIDD) framework. This facilitates the generation of rationale for dose regimen selection, clinical study design, safety margin assessment and identification of circumstances where dose adjustment or patient selection/stratification should be considered. The section head is focused on people leadership with accountability for Clinical Pharmacology resource internally and externally across programs and provides mentorship and career development guidance to staff. The section head collaborates with additional departmental leaders to ensure that the diverse Biogen portfolio has optimal leadership from clinical pharmacology and pharmacometrics.

Responsibilities

• Leads and manages high profile clinical pharmacology activities including training, CDP and study designs with R&D across drug modalities and Biogen disease areas
• Leads clinical pharmacology efforts in early and late stage (e.g., study design, protocol concepts/protocols preparation, clinical phase oversight, data analysis, and reporting) within assigned programs to yield high value PK/PD insight for critical decisions. Analyzes results, interprets, and recommends action based on study results.
• Ability to represent clinical pharmacology function at governance (DPAC, RDGC, TRC) and external advisory boards
• Provides extensive regulatory strategy expertise for drug filings and is responsible for Clinical Pharmacology sections of regulatory documents. Maintains cutting edge knowledge of best regulatory practices, Clinical Pharmacology technology and drug development precedent.
• Engages in cross-functional activities providing Clinical Pharmacology input and provides a source of Clinical Pharmacology expertise and advice to other functions across the Company. Participates in and provides Clinical Pharmacology perspective to cross-functional committees and activities.
• Maintains extensive scientific awareness and presence in Clinical Pharmacology, publishes multiple manuscripts and posters, presents at Scientific Conferences and other scientific forums. Engages with consultants and advisors in the field, as well as the scientific community at large.
• Manages and/or mentors staff within the function and matrix leadership across projects. Develops expertise in highly specialized and/or novel aspects of Clinical Pharmacology and serves as a reference source in these for his 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
• International recognized expert in Quantitative Clinical Pharmacology
• Solid experience in developing Clinical Pharmacology strategy, designing/implementing Clinical Pharmacology studies
• Strong knowledge of the drug development process and overall familiarity with the regulatory process. Direct experience in preparing regulatory submissions and responding to health authority questions.
• Extensive record of publications, presentations, invited lectures, and other scientific activities
• Active knowledge of advanced methods for Quantitative Pharmacology and PMx analyses
• Experience with use of PK/PD software packages such as Phoenix WinNonlin, SimCYP, NONMEM, Monolix, R, Adapt, MATLAB, SAS

Skills

• Leadership and people management
• Strategic and analytical thinking in clinical pharmacology
• Strong regulatory and cross-functional collaboration capabilities
• Excellent communication and scientific publishing

Education

• Ph.D., M.D./Ph.D., or Pharm.D. in Clinical Pharmacology, pharmacokinetics, or related field