"Senior Director, ( MD) Global Development Lead, Early Development"
Pfizer
Associate Scientific Director, Clinical Pharmacology
Biogen
full-time
Posted on:
Origin: • 🇺🇸 United States • California
Visit company websiteSalary
💰 $144,000 - $240,000 per year
Job Level
Lead
About the role
- Provide clinical pharmacology expertise to program and study teams throughout a molecule’s lifecycle (discovery through development) Provide functional representation on development program s and study teams and identify opportunities where modeling and simulation can ad vance the understanding of pharmacological activity, efficacy and safety Develop & implement the clinical pharmacology development plan, considering all aspects (strategic, scientific, translational, and clinical) Define key milestones and decisions within the clinical pharmacology development plan and identify risks and mitigation strategies Lead execution of clinical pharmacology studies & analyses; interpret results and recommend action based on results Conduct hands - o n quantitative ana lysis and present the findings to multidisciplinary project teams Serve as lead author and key contributor to clinical pharmacology sections of documents Serve as the subject matter expert in interactions with Health Authorities Seek input from and ensure alignment with cross-functional partners, consultants, experts, and vendors as needed Work with program and/or study teams to achieve program goals and provide deliverables in approved timeframes Maintain cutting edge knowledge of best regulatory practices, quantitative/clinical pharmacology methodology , and drug development precedent
Requirements
- PhD or MD/PhD in Pharmacology, Pharmacokinetics, Pharmaceutics or PharmD or other suitable related fields 5+ years relevant industry experience (clinical pharmacology and/or clinical PK/PD) Ability to analyze and interpret PK and PK/PD data utilizing sound scientific principles Experience with designing and implementing relevant elements of clinical studies and/or dedicated Clinical Pharmacology studies Ability to develop Clinical Pharmacology strategy in the context of the broader development paradigm Knowledge of and ability to apply appropriate regulatory and ICH guidelines with regard to the acquisition, analysis, and interpretation of clinical pharmacology data Hands - on experience with developing and implementing Quantitative Systems Pharmacology (QSP) models, and/or population PK, PKPD, exposure-response analyses Experience with Model Informed Drug Development (MIDD) paired meeting program is a plus Proficiency with use of PK/PD software packages such as Phoenix, R, NONMEM . E xperience with Monolix and MATLAB is a plus Excellent oral and written communication skills for effective interactions in various environments including, but not limited to, multidisciplinary teams, regulatory agencies, scientific symposia, and advisory boards
