Associate Director, Quantitative Pharmacology

🕒 3 days ago

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Regeneron

10,000+ employees

Founded 1988

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

💰 Post-IPO Equity on 2023-10

Biotechnology • Pharmaceuticals • Healthcare Insurance

Regeneron is a biotechnology company dedicated to turning scientific discoveries into life-changing medicines. The company focuses on a range of serious diseases including allergic, cardiovascular, and metabolic diseases, neuroscience, oncology, hematology, ophthalmology, and rare diseases. It achieves this by integrating biology and technology to develop cutting-edge biologics and genetic medicines. Regeneron is committed to health equity, environmental sustainability, and supporting future STEM talent through initiatives like the Regeneron Science Talent Search. By maintaining high ethical standards and corporate responsibility, Regeneron aims to push the boundaries of science for better healthcare solutions.

📋 Description

• 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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