Director, Clinical Pharmacology

Job Description

As the Director of Clinical Pharmacology, you will serve as the clinical pharmacology lead on several clinical development or program teams providing strategic leadership and execution of clinical development plans that include characterization and prediction of the pharmacokinetics, pharmacodynamics and drug metabolism (PPDM) of the drug candidate in selected preclinical and all clinical areas. You will provide rationale for dose regimen selection, safety margin assessment and identification of circumstances where dose adjustment or patient selection/stratification should be considered.  You will also serve as a manager/mentor to less experienced staff and as a Clinical Pharmacology resource within the function and across the company.

What You'll Do

• Drive the development and execution of the Clinical Pharmacology Strategy and Plan of several clinical development and/or program teams.
• Provide key components of the Early Development Plan, advises teams on Clinical Pharmacology Strategy and science and provides input to line management.
• Work with clinical development and/or program teams to achieve program goals and provide deliverables in approved timeframes.
• Lead clinical pharmacology efforts (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.
• Analyze results, interprets, and recommends action based on study results.
• Provide extensive regulatory strategy expertise for drug filings and is responsible for Clinical Pharmacology sections of regulatory documents.
• Maintain cutting edge knowledge of best regulatory practices, Clinical Pharmacology technology and drug development precedent.
• Engage in cross-functional activities providing Clinical Pharmacology input and provide a source of Clinical Pharmacology expertise and advice to other functions across the Company.  Participate in and provides Clinical Pharmacology perspective to cross-functional committees and activities.
• Maintain extensive scientific awareness and presence in Clinical Pharmacology, publishes multiple manuscripts and posters, presents at Scientific Conferences and other scientific forums.
• Engage with consultants and advisors in the field, as well as the scientific community at large.
• Manage and/or mentors junior staff within the function. 
• Develop expertise in highly specialized and/or novel aspects of Clinical Pharmacology and serve 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
• 8+ years of industry experience in Clinical Pharmacology & PPDM.
• 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 in leading teams and/or managing professional staff.
• Demonstrates strong team work in a multidisciplinary environment
• Ability to manage and mentor more junior scientists
• 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

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.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empo