Note: The job is a remote job and is open to candidates in USA. Biogen’s West Coast Hub, based in South San Francisco, is focused on transforming the lives of patients with severe immune-mediated diseases. The Lead, Clinical Pharmacology, Immunology will provide strategic leadership in the development and execution of clinical pharmacology plans for drug candidates.
Responsibilities
- Provide clinical pharmacology expertise to program and study teams throughout a molecule’s lifecycle (discovery through development)
- Provide functional representation on development programs and study teams and identify opportunities where modeling and simulation can advance 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-on quantitative analysis 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
Skills
- 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
- 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
- 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. Experience with Monolix and MATLAB is a plus
Benefits
- Participation in Biogen’s LTI grants and other incentive programs
- Medical, dental, life, long and short-term disability insurances
- Vacation
- End-of-year shutdown
- 401K participation and matching contributions
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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