Associate Director, Quantitative Pharmacology
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Job Description
Associate Director leading model-informed drug development strategies for therapeutic areas at Regeneron. Collaborating cross-functionally to inform regulatory strategy from development through submission.
Responsibilities:
- Leading model-informed drug development strategies supporting one or more therapeutic areas across modalities including antibodies, siRNA, and gene therapies.
- 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.
Requirements:
- 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.
Benefits:
- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave)
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