Biogen Senior Scientist, Clinical Pharmacology in Cambridge, Massachusetts
About the Role: * The Clinical Pharmacologist serves as the clinical pharmacology and pharmacometrics lead on clinical study management teams providing execution of 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. This person also executes and oversees development and application of quantitative pharmacology models, providing rationale for dose regimen selection, safety margin assessment and identification of circumstances where dose adjustment or patient selection/stratification should be considered. *What You'll Do: * With appropriate supervision, the candidate is responsible for providing key components of the Clinical Development Plan (strategy/analysis through final reports) and for providing input and scientific opinion to project teams, line management, and governance bodies. * With appropriate supervision, leads preclinical and clinical pharmacology study efforts (e.g., study design, protocol concepts/protocols preparation, clinical phase oversight, and reporting) within assigned programs to yield high value PK/PD/DM insight for future critical decisions. Analyzes results, interprets, and recommends action based on study results and program level. * Work with study and program teams to achieve program goals and provide deliverables in approved timeframes. * With guidance, identifies program and study-specific issues. Generates potential solutions to issues and proposes those solutions to management and/or study teams. * Develops and maintains strong knowledge of best regulatory practices, analytical technology and drug development precedent. * With oversight provides insightful regulatory strategy for drug filings and is responsible for Clinical Pharmacology sections of regulatory documents. Required Skills: * Ph.D., M.D./Ph.D., or Pharm.D. in biomedical engineering, applied pharmacology, pharmacokinetics, or a related field with 0-2+ years of direct industry or post-doc experience in clinical pharmacology and advanced modeling & simulation. * Demonstrates a strong understanding of and experience in PK/PD principles and quantitative analysis. * Employs continuous improvement in knowledge and practical understanding of Mechanistic/Systems Pharmacology, Modeling and Simulation, Clinical Pharmacology and application of this knowledge in the program team setting. * Understands and can apply appropriate regulatory and ICH guidelines in the design of all studies. * Can manage a diverse, time-sensitive workload. * Possesses strong communication skills requiring minimal oversight in drafting grammatically correct written documents and making oral presentations. Preferred Skills: * Experience with use of PK/PD software packages such as Phoenix WinNonlin, SimCYP, NONMEM, Monolix, R, Adapt, MATLAB, SAS 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.