Lead, Clinical Pharmacology, Immunology

Summary

Join us as a Lead, Clinical Pharmacology, Immunology at Biogen's West Coast Hub in South San Francisco, CA. As a clinical pharmacology lead, you will provide strategic leadership and expertise to program and study teams throughout the drug development lifecycle.

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 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
• Experience with use of PK/PD software packages such as Phoenix, R, SimCYP, NONMEM, Monolix, Adapt, MATLAB, SAS
• 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

Responsibilities

• Provide clinical pharmacology expertise to program and study teams throughout a molecule’s lifecycle (discovery through development)
• Provide functional representation on development program and study teams
• 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
• Serve as lead author and key contributor to clinical pharmacology sections of clinical and regulatory documents
• 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

Benefits

• Medical insurance
• Dental insurance
• Life insurance
• Long and short-term disability insurances
• Vacation
• End-of-year shutdown
• 401K participation and matching contributions