Associate Director, Quantitative Pharmacology

Regeneron PharmaceuticalsTarrytown, NY
57dOnsite

About The Position

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. A day in the life of an Associate Director may look like: 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. This may be the right role for you if you: Want to make a visible impact on the organization by driving data-driven decisions that shape clinical and regulatory strategy. Thrive in multi-disciplinary environments, bridging discovery, clinical, and commercial teams. Communicate complex modeling concepts clearly and persuasively to diverse stakeholders. Have strong collaboration and leadership skills, influencing cross-functional teams without formal authority. Can independently design, execute, and oversee multiple modeling workstreams simultaneously.

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.
  • Exceptional communication and interpersonal skills, with the ability to influence and partner effectively across technical and non-technical teams.

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.

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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What This Job Offers

Job Type

Full-time

Career Level

Director

Industry

Chemical Manufacturing

Education Level

Ph.D. or professional degree

Number of Employees

5,001-10,000 employees

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