Associate Scientific Director, Clinical Pharmacology

Biogen

1d•$144,000 - $240,000

About The Position

As the Associate Scientific Director, Clinical Pharmacology you will serve as the clinical pharmacology lead on program and study teams, providing strategic leadership in the development and execution of clinical pharmacology plans for drug candidates. You will integrate knowledge of clinical and quantitative pharmacology to optimize and provide rationale for doses, dosage regimens, and study designs throughout the drug development lifecycle. You are a scientifically driven clinical pharmacologist with deep expertise in PK/PD modeling, quantitative pharmacology, and translational science. You bring hands-on experience leading clinical pharmacology strategy across early and late-stage development, applying Model-Informed Drug Development (MIDD) principles to optimize dose selection, study design, and regulatory strategy. You thrive in cross-functional settings, bridging science and strategy to advance innovative therapies for patients.

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, 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