Sr. Director, Clinical Pharmacology Pharmacometrics
Posted on: September 21, 2022
The Senior Director of Clinical Pharmacology & Pharmacometrics
serves as the Disease Area Portfolio Lead overseeing several
clinical development or program teams providing strategic
leadership and execution of clinical development plans from Phase
1-Phase 4 programs. This includes characterization and prediction
of the pharmacokinetics, pharmacodynamics, efficacy of drug
candidates into a Model-Informed Drug Development (MIDD) framework.
This person also provides 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 Senior Director
also serves as a manager/mentor Clinical Pharmacologists up to
Director level and manages Clinical Pharmacology resource
internally and externally across programs.
- 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 Disease Area Portfolio including several drug
- Drives the development and execution of the Clinical
Pharmacology Strategy and Plan of several clinical development
and/or program teams. Provides key components of the Early
Development Plan, advises teams on Clinical Pharmacology Strategy
and science and provides input to line management. Works with
clinical development and/or program teams to achieve program goals
and provide deliverables in approved timeframes
- 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
- 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 junior 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.
- 12+ years of direct industry experience in Clinical
Pharmacology & PPDM.
- Experience in leading teams and/or managing professional
- International recognized expert in Quantitative Clinical
- Solid experience in developing Clinical Pharmacology strategy,
designing/implementing Clinical Pharmacology studies
- Excellent knowledge of the principles of Clinical Pharmacology
- Demonstrates strong team work in a multidisciplinary
- 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
- Extensive record of publications, presentations, invited
lectures, and other scientific activities
- Active knowledge of advanced methods for Quantitative
Pharmacology and PMx analyses
- Ph.D., M.D., or Pharm.D. in Clinical Pharmacology,
pharmacokinetics, or a related field
- Experience with use of PK/PD software packages such as -Phoenix
WinNonlin, SimCYP, NONMEM, Monolix, R, Adapt, MATLAB, SAS
Our mission to find therapies for neurological and rare diseases is
a unique focus within our industry and this shared purpose is what
connects us as a team. We work together to overcome obstacles and
to follow the science. We are resilient as we strive to make an
impact on our patients' lives and on changing the course of
medicine. Together, we pioneer. Together, we thrive.
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Keywords: Biogen, Cambridge , Sr. Director, Clinical Pharmacology Pharmacometrics, Healthcare , Cambridge, Massachusetts
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