Associate Director, Quantitative Pharmacology
Regeneron
Full-time
On-site
Tarrytown, NY
Clinical Research and Development
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Role Summary
We are seeking a highly motivated Associate Director (AD) to join the Quantitative Pharmacology (QP) group. The AD will lead model-informed drug development strategies supporting one or more therapeutic areas across modalities including antibodies, siRNA, and gene therapies. This role combines scientific depth with cross-functional leadership to inform dose selection, trial design, and regulatory strategy from early development through submission.
Responsibilities
- Driving model-informed development (MIDD) and pharmacometrics strategies in partnership with Clinical Pharmacology, Biostatistics, Clinical and Translational teams to support regulatory and clinical decision-making.
- Leading the QP evaluation of one or more assets, accountable for timely delivery of population PK/PD, exposure–response, and translational modeling analyses.
- Representing QP at program and governance meetings, communicating quantitative insights clearly to non-modeling audiences.
- Contributing to regulatory interactions and authoring key components of regulatory documents related to QP (e.g., IB, briefing books, etc.).
- Mentoring and developing junior scientists and fostering a culture of scientific rigor and collaboration.
- Identifying and implementing process improvements, new modeling approaches, and innovative quantitative tools to enhance efficiency and impact.
- Ensuring analyses and documentation are of the highest scientific quality and regulatory compliance.
Qualifications
- PhD in Quantitative Pharmacology, Pharmacometrics, Engineering, or a related field with 6+ years of post-doctoral or industry experience; or MS with 9+ years of relevant experience.
- Demonstrated expertise in population PK/PD, exposure–response, or mechanistic modeling (systems biology, or QSP) using tools such as NONMEM, Monolix, Simulx, MATLAB/Simbiology and R.
- Proven track record of delivering analyses supporting regulatory submissions and engaging directly with agencies (e.g., FDA, EMA, PMDA).
- Hands-on experience with a broad range of quantitative and computational tools and a strong publication record.
- Exceptional communication and interpersonal skills, with the ability to influence and partner effectively across technical and non-technical teams.
Education
- PhD or MS in a related field as specified above.