Northeast
Position Overview
The Associate Director will lead quantitative modeling strategies to support the development of therapeutics across multiple modalities. This role combines hands-on pharmacometrics expertise with strategic collaboration to guide dose selection, study design, and regulatory decision-making from early development through submission.
Key Responsibilities
- Lead model-informed strategies in partnership with clinical, biometrics, and translational teams
- Oversee population PK/PD, exposure–response, and mechanistic modeling across assigned programs
- Translate complex modeling results into actionable insights for internal teams and regulatory bodies
- Contribute to regulatory documents and represent quantitative pharmacology in agency interactions
- Mentor junior scientists and support innovation through new tools and methods
- Ensure high-quality, compliant analyses aligned with development goals
Essential Qualifications
- Ph.D. in Pharmacometrics, Engineering, or related field with 6+ years of experience; or M.S. with 9+ years
- Strong background in PK/PD modeling, QSP, or systems pharmacology
- Skilled in tools such as NONMEM, Monolix, Simulx, MATLAB, and R
- Experience supporting regulatory submissions and engaging with health authorities
- Excellent communication and leadership skills in cross-functional environments