Associate Director, Quantitative Clinical Pharmacology (QCP) Lead

Position Objectives:

• Global/regional Clinical Pharmacology Lead for multiple projects; drive clinical pharmacology strategy from pre-FIH through life-cycle management and enable MIDD.

Responsibilities:

• Lead strategic, scientific, and operational aspects of multiple drug development projects with independence; primary responsibility for dosage selection and generation of causality evidence.
• Integrate pharmacokinetic, pharmacodynamic, efficacy, and safety data from multiple sources to optimize dosing for different populations.
• Draft and execute clinical pharmacology plans, integrating M&S, in collaboration with pharmacometrics, statistics, and DMPK.
• Enable MIDD practices and modeling/simulation approaches (e.g., QSP, MBMA) for internal decisions and regulatory interactions.
• Represent Clinical Pharmacology in meetings with global/regional regulatory agencies; prepare clinical pharmacology summary documents for regulatory submissions.
• Oversee and/or independently perform PK, PD, and pharmacometric analyses; interpret PK/PD data with DSI and external partners.
• Maintain good clinical practice, compliance, and ethics; mentor junior staff.
• Participate in Business Development due diligence (when requested) and contribute to infrastructure/cross-functional best practices.

Qualifications (Education/Experience):

• PharmD or PhD with 5+ years in a quantitative field with exposure to clinical pharmacology/PK-PD.
• MS with 8+ years in a quantitative field with exposure to clinical pharmacology/PK-PD.

Technical/Skills:

• Advanced clinical pharmacology experience across early/late stage and post-marketing studies.
• Advanced knowledge of drug development process and cross-functional interfaces (pharmacometrics, statistics, drug safety, clinical sciences, outcomes, digital health, pharma/device, global regulatory affairs).
• Advanced regulatory knowledge for trial design, analysis, and submissions (ICH, FDA, EMA, etc.).
• Hands-on integration of PK/PD/efficacy/safety data for dose selection and decision-making.

Benefits (if applicable):

• U.S. based employees may be eligible for medical/dental/vision, 401(k) with match, disability, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits; up to 80 hours sick time/year; paid vacation accrual up to 120 hours for new hires.