Associate Director, Quantitative Pharmacology
Regeneron
August 11, 2026
Remote friendly (Tarrytown, NY)
United States
Clinical Research and Development
Associate Director (AD), Quantitative Pharmacology (QP)
Responsibilities:
- Lead model-informed drug development (MIDD) and pharmacometrics strategies with Clinical Pharmacology, Biostatistics, Clinical, and Translational teams to support regulatory and clinical decision-making.
- Lead QP evaluation of one or more assets; deliver population PK/PD, exposure–response, and translational modeling analyses on time.
- Represent QP at program and governance meetings; communicate quantitative insights clearly to non-modeling audiences.
- Contribute to regulatory interactions and author key QP components of regulatory documents (e.g., IB, briefing books).
- Mentor and develop junior scientists; foster scientific rigor and collaboration.
- Identify and implement process improvements, new modeling approaches, and innovative quantitative tools to enhance efficiency and impact.
- Ensure analyses and documentation meet the highest scientific quality and regulatory compliance.
Requirements:
- PhD in Quantitative Pharmacology, Pharmacometrics, Engineering, or related field.
- 6+ years post-doctoral or industry experience; or MS with 9+ years relevant experience.
- Demonstrated expertise in population PK/PD, exposure–response, or mechanistic modeling (systems biology/QSP) using tools such as NONMEM, Monolix, Simulx, MATLAB/Simbiology, and R.
- Proven track record delivering analyses supporting regulatory submissions and engaging with agencies (e.g., FDA, EMA, PMDA).
- Hands-on experience with quantitative/computational tools and strong publication record.
- Exceptional communication and interpersonal skills; ability to partner across technical and non-technical teams.
Application instructions:
- Apply now.
Responsibilities:
- Lead model-informed drug development (MIDD) and pharmacometrics strategies with Clinical Pharmacology, Biostatistics, Clinical, and Translational teams to support regulatory and clinical decision-making.
- Lead QP evaluation of one or more assets; deliver population PK/PD, exposure–response, and translational modeling analyses on time.
- Represent QP at program and governance meetings; communicate quantitative insights clearly to non-modeling audiences.
- Contribute to regulatory interactions and author key QP components of regulatory documents (e.g., IB, briefing books).
- Mentor and develop junior scientists; foster scientific rigor and collaboration.
- Identify and implement process improvements, new modeling approaches, and innovative quantitative tools to enhance efficiency and impact.
- Ensure analyses and documentation meet the highest scientific quality and regulatory compliance.
Requirements:
- PhD in Quantitative Pharmacology, Pharmacometrics, Engineering, or related field.
- 6+ years post-doctoral or industry experience; or MS with 9+ years relevant experience.
- Demonstrated expertise in population PK/PD, exposure–response, or mechanistic modeling (systems biology/QSP) using tools such as NONMEM, Monolix, Simulx, MATLAB/Simbiology, and R.
- Proven track record delivering analyses supporting regulatory submissions and engaging with agencies (e.g., FDA, EMA, PMDA).
- Hands-on experience with quantitative/computational tools and strong publication record.
- Exceptional communication and interpersonal skills; ability to partner across technical and non-technical teams.
Application instructions:
- Apply now.