Regeneron
AssociateDirectorQuantitativePharmacology
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“Associate Director Quantitative Pharmacology at Regeneron. Skills: Quantitative Pharmacology, Model-informed development, Pharmacometrics, PK/PD modeling. Drive model-informed development strategies. Drive pharmacometrics strategies”
What You'll Achieve.
Inform dose selection; Inform trial design; Inform regulatory strategy; Support regulatory decision-making; Support clinical decision-making; Timely delivery of analyses
Industry & Context.
Data-driven decisions
What They're Looking For.
Must Have
PhD in Quantitative Pharmacology, Pharmacometrics, Engineering, or related field, 6+ years post-doctoral or industry experience, MS with 9+ years relevant experience, Expertise in population PK/PD, exposure-response, or mechanistic modeling, Experience with NONMEM, Monolix, Simulx, MATLAB/Simbiology and R, Track record of delivering analyses supporting regulatory submissions, Engaging directly with agencies (FDA, EMA, PMDA), Hands-on experience with quantitative and computational tools, Publication record, Exceptional communication and interpersonal skills
Nice to Have
PhD preferred, Specific ML framework experience, Cloud platform certs
What You'll Do.
Drive model-informed development strategies
Drive pharmacometrics strategies
Lead QP evaluation of assets
Deliver population PK/PD analyses
Deliver exposure-response analyses
Deliver translational modeling analyses
Represent QP at program meetings
Communicate quantitative insights
Contribute to regulatory interactions
Author regulatory documents
Mentor junior scientists
Develop junior scientists
Foster scientific rigor
Identify process improvements
Implement process improvements
Implement new modeling approaches
Implement innovative quantitative tools
Ensure highest scientific quality
Ensure regulatory compliance
How You'll Work.
Team & Collaboration
Cross-functional leadership; Partnership with Clinical Pharmacology; Partnership with Biostatistics; Partnership with Clinical teams; Partnership with Translational teams; Partnership with non-modeling audiences; Partnership across technical teams; Partnership across non-technical teams
Communication Scope
Communicate quantitative insights; Communicate complex modeling concepts; Persuasive communication
Full Job Description
We are seeking a highly motivated Associate Director to join the Quantitative Pharmacology (QP) group. The Associate Director 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 authori
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