Biogen · 4 months ago
Associate Scientific Director, Clinical Pharmacology
San Francisco, CA
Full-time
Onsite
Senior Level
$144K/yr - $240K/yr
5+ years expBiogen is a mid-sized biotechnology company focused on transforming the lives of patients with severe immune-mediated diseases. They are seeking a Lead, Clinical Pharmacology, Immunology to provide strategic leadership in clinical pharmacology plans and optimize dosage regimens throughout the drug development lifecycle.
BiotechnologyHealth CareNeuroscienceTherapeutics
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
Qualification
Required
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
Proficiency with use of PK/PD software packages such as Phoenix, R, NONMEM. Experience 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
Preferred
Experience with Model Informed Drug Development (MIDD) paired meeting program
Benefits
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
Company
Biogen
Biogen is an American biotechnology company that provides therapeutics for neurological, autoimmune, and rare diseases.
Founded in 1978Cambridge, Massachusetts, USA
5001-10000 employees
H1B Sponsorship
Biogen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (100)
2024 (93)
2023 (101)
2022 (134)
2021 (104)
2020 (114)
Funding
Current Stage
Public CompanyTotal Funding
$1.5BKey Investors
JP Morgan
2023-08-28Post Ipo Debt· $1.5B
1991-09-27IPO
Leadership Team
Robin C. Kramer
Executive Vice President, Chief Financial Officer
Priya Singhal
Executive Vice President, Head of Development
Recent News
Pharmaceutical Technology
2026-01-05
thecanadianpressnews.ca
2025-12-24
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