Associate Scientific Director, Clinical Pharmacology
Biogen
3 months ago
Remote friendly (United States)
United States
$144,000 - $240,000 USD yearly
Clinical Research and Development
Associate Scientific Director, Clinical Pharmacology
What You’ll Do
- 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 and implement the clinical pharmacology development plan (strategic, scientific, translational, and clinical)
- Define key milestones and decisions within the clinical pharmacology development plan; identify risks and mitigation strategies
- Lead execution of clinical pharmacology studies and analyses; interpret results and recommend action
- 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 deliverables in approved timeframes
- Maintain cutting-edge knowledge of best regulatory practices, quantitative/clinical pharmacology methodology, and drug development precedent
Who You Are
- Scientifically driven clinical pharmacologist with deep expertise in PK/PD modeling, quantitative pharmacology, and translational science
- Hands-on experience leading clinical pharmacology strategy across early and late-stage development using Model-Informed Drug Development (MIDD)
- Thrives in cross-functional settings, bridging science and strategy
Qualifications
- 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)
Required/Preferred Skills
- Analyze and interpret PK and PK/PD data using sound scientific principles
- Design and implement elements of clinical studies and/or dedicated Clinical Pharmacology studies
- Develop Clinical Pharmacology strategy in the broader development paradigm
- Apply appropriate regulatory and ICH guidelines to acquisition, analysis, and interpretation of clinical pharmacology data
- Experience with PK/PD software: Phoenix, R, SimCYP, NONMEM, Monolix, Adapt, MATLAB, SAS
- Excellent oral and written communication skills for multidisciplinary teams, regulatory agencies, scientific symposia, and advisory boards
Benefits (as explicitly listed)
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including fitness reimbursement
- Short- and Long-Term Disability insurance
- 15+ days paid vacation and end-of-year shutdown (Dec 26–Dec 31)
- Up to 12 paid holidays + 3 paid days off for Personal Significance
- 80 hours sick time per calendar year
- Paid Maternity and Parental Leave
- 401(k) with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement up to $10,000 per calendar year
- Employee Resource Groups participation
What You’ll Do
- 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 and implement the clinical pharmacology development plan (strategic, scientific, translational, and clinical)
- Define key milestones and decisions within the clinical pharmacology development plan; identify risks and mitigation strategies
- Lead execution of clinical pharmacology studies and analyses; interpret results and recommend action
- 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 deliverables in approved timeframes
- Maintain cutting-edge knowledge of best regulatory practices, quantitative/clinical pharmacology methodology, and drug development precedent
Who You Are
- Scientifically driven clinical pharmacologist with deep expertise in PK/PD modeling, quantitative pharmacology, and translational science
- Hands-on experience leading clinical pharmacology strategy across early and late-stage development using Model-Informed Drug Development (MIDD)
- Thrives in cross-functional settings, bridging science and strategy
Qualifications
- 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)
Required/Preferred Skills
- Analyze and interpret PK and PK/PD data using sound scientific principles
- Design and implement elements of clinical studies and/or dedicated Clinical Pharmacology studies
- Develop Clinical Pharmacology strategy in the broader development paradigm
- Apply appropriate regulatory and ICH guidelines to acquisition, analysis, and interpretation of clinical pharmacology data
- Experience with PK/PD software: Phoenix, R, SimCYP, NONMEM, Monolix, Adapt, MATLAB, SAS
- Excellent oral and written communication skills for multidisciplinary teams, regulatory agencies, scientific symposia, and advisory boards
Benefits (as explicitly listed)
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including fitness reimbursement
- Short- and Long-Term Disability insurance
- 15+ days paid vacation and end-of-year shutdown (Dec 26–Dec 31)
- Up to 12 paid holidays + 3 paid days off for Personal Significance
- 80 hours sick time per calendar year
- Paid Maternity and Parental Leave
- 401(k) with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement up to $10,000 per calendar year
- Employee Resource Groups participation