Associate Scientific Director, Clinical Pharmacology – Remote / San Francisco, USA
Location: Remote (USA) / San Francisco, CA
Category: Clinical Pharmacology / Medical & Clinical Affairs
Employment Type: Full-Time
Experience Required: Minimum 5 years in industry (clinical pharmacology and/or PK/PD)
About the Role
Biogen’s West Coast Hub, based in South San Francisco, is dedicated to transforming the lives of patients with severe immune-mediated diseases by developing novel, targeted therapies with significant clinical impact. We are seeking a highly skilled Associate Scientific Director, Clinical Pharmacology to provide strategic leadership on program and study teams, contributing to the development and execution of clinical pharmacology plans for drug candidates.
This position can be based in South San Francisco or fully remote within the USA. The role requires in-depth expertise in clinical and quantitative pharmacology to optimize dosing regimens and study designs throughout the drug development lifecycle.
Key Responsibilities
Provide clinical pharmacology expertise throughout a molecule’s lifecycle, from discovery to development.
Serve as a functional representative on development programs and study teams, identifying opportunities for modeling and simulation to enhance understanding of pharmacology, efficacy, and safety.
Develop and implement clinical pharmacology development plans, including strategic, scientific, translational, and clinical considerations.
Define key milestones and decision points, identifying risks and mitigation strategies.
Lead execution of clinical pharmacology studies and analyses, interpret results, and recommend actions.
Conduct hands-on quantitative analyses and present findings to multidisciplinary teams.
Author and review clinical pharmacology sections of regulatory documents.
Serve as a subject matter expert in interactions with regulatory authorities.
Collaborate with cross-functional partners, consultants, and vendors to ensure alignment and program success.
Maintain up-to-date knowledge of regulatory best practices, quantitative pharmacology methods, and drug development standards.
Required Qualifications
PhD or MD/PhD in Pharmacology, Pharmacokinetics, Pharmaceutics, PharmD, or related fields.
Minimum 5 years of relevant industry experience in clinical pharmacology and/or clinical PK/PD.
Strong ability to analyze and interpret PK and PK/PD data using sound scientific principles.
Experience in designing and implementing clinical studies, including Clinical Pharmacology studies.
Knowledge of regulatory and ICH guidelines for acquisition, analysis, and interpretation of clinical pharmacology data.
Hands-on experience with Quantitative Systems Pharmacology (QSP), population PK/PD, and exposure-response analyses.
Familiarity with Model-Informed Drug Development (MIDD) is a plus.
Proficiency with software tools such as Phoenix, R, NONMEM; experience with Monolix and MATLAB is advantageous.
Excellent verbal and written communication skills for effective interactions with multidisciplinary teams, regulatory agencies, and scientific forums.
Benefits & Compensation
Base Salary: $144,000 – $240,000 (dependent on experience, location, and internal equity).
Participation in long-term incentive (LTI) programs and other performance-based incentives.
Comprehensive benefits including medical, dental, vision, life insurance, and disability coverage.
Paid vacation and company shutdown period at year-end.
401(k) participation with company matching.
Tuition reimbursement up to $10,000 per year and employee stock purchase plan.
Access to wellness programs, employee resource groups, and professional development opportunities.
Why Biogen?
At Biogen, we are a global team with a pioneering spirit, committed to delivering life-changing medicines. As a mid-sized biotechnology company, we combine the stability of an established business with the opportunity for individuals to make significant impact. We value diverse perspectives, collaboration, and innovation, fostering an environment where every employee can thrive.
Biogen is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to sex, gender identity, sexual orientation, marital status, race, color, national origin, religion, disability, veteran status, or any other legally protected status.
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