Sr. Director, MS&I Development Unit Liaison, Clinical Pharmacology & Pharmacometrics

Job Description

The Senior Director and Development Unit Liaison of Clinical Pharmacology & Pharmacometrics (CPP) serves as the Disease Area Portfolio Subject Matter Expert (SME) providing CPP expertise and advisement to several clinical development or program teams across Phase 1-Phase 4.  This includes characterization and prediction of the pharmacokinetics, pharmacodynamics, and efficacy of drug candidates into a Model-Informed Drug Development (MIDD) framework.  This person advises R&D on 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 an SME mentor for Clinical Pharmacologists and collaborates with DU and CPP leaders to ensure support at the DU portfolio level.

Principle responsibilities

• Provides SME insight and input  into high profile clinical pharmacology activities including training, CDP and study designs with R&D across drug modalities and Biogen disease areas.
• Provides leading SME input into MS & Immunology Disease Area Portfolio for CPP function .
• Drives the SME support and input into development and execution of the Clinical Pharmacology Strategy and Plan of several clinical development and/or program teams led by R&D. 
• Provides key SME 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 support the achievement of program goals and deliverables in approved timeframes.
• Provides SME input and support into 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 assist in yielding high value PK/PD insight for critical decisions made by R&D.
• Analyzes results, interprets, and recommends action based on study results.
• Provides extensive regulatory expertise for drug filings and is responsible SME for Clinical Pharmacology sections of regulatory documents
• Maintains cutting edge knowledge of best regulatory practices, Clinical Pharmacology technology and drug development precedent.
• Engages in supporting 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.  Mentors staff within the function and provides 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.

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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 & PPDM.
• International recognized expert in Quantitative Clinical Pharmacology
• Solid experience in developing Clinical Pharmacology strategy, designing/implementing Clinical Pharmacology studies
• Demonstrates strong teamwork in a multidisciplinary environment as well as the ability to mentor more junior scientists
• 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

Additional Information

Why Biogen?

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.

*Please note that this position can be located in both the US and UK.

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpo