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 programs and study teams; identify opportunities where modeling and simulation advance understanding of pharmacological activity, efficacy, and safety
- 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
- Conduct hands-on quantitative analysis and present findings to multidisciplinary project teams
- Serve as lead author and key contributor to clinical pharmacology sections of documents
- Serve as subject matter expert for 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 deliverables in approved timeframes
- Maintain cutting-edge knowledge of best regulatory practices, quantitative/clinical pharmacology methodology, and drug development precedent

Qualifications
- PhD or MD/PhD in Pharmacology, Pharmacokinetics, Pharmaceutics or PharmD (or other suitable related field)
- 5+ years relevant industry experience (clinical pharmacology and/or clinical PK/PD)
- Ability to analyze and interpret PK and PK/PD data using sound scientific principles
- Experience designing and implementing relevant elements of clinical studies and/or dedicated Clinical Pharmacology studies
- Ability to develop Clinical Pharmacology strategy within the broader development paradigm
- Knowledge of and ability to apply appropriate regulatory and ICH guidelines for clinical pharmacology data acquisition, analysis, and interpretation
- Hands-on experience with Quantitative Systems Pharmacology (QSP) models and/or population PK, PKPD, and exposure-response analyses
- Experience with MIDD paired meeting program is a plus
- Proficiency with PK/PD software such as Phoenix, R, NONMEM; experience with Monolix and MATLAB is a plus
- Excellent oral and written communication skills for multidisciplinary teams, regulatory agencies, scientific symposia, and advisory boards

Location/Eligibility
- South San Francisco office or fully Remote; candidate must reside within the USA

Benefits (explicitly stated)
- Base compensation range: $144,000.00–$240,000.00
- Eligible for LTI grants and other incentive programs; participation in 401(k) with matching contributions
- Medical, dental, vision, and life insurances; fitness/wellness programs (fitness reimbursement); short- and long-term disability insurance
- Paid vacation (minimum 15 days) and end-of-year shutdown (Dec 26–Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance; 80 hours sick time per calendar year
- Paid maternity and parental leave
- Employee stock purchase plan; tuition reimbursement up to $10,000 per calendar year; Employee Resource Groups participation