Senior Clinical Pharmacologist

Responsibilities

• Plan, design, implement, and analyze in-vivo and in-vitro pharmacokinetic and pharmacodynamic (PK/PD) studies to advance scientific understanding of research programs.
• Perform complex analyses including NCA, compartmental modeling, PopPK, translational modeling, disease modeling, and Exposure-Response (E-R) analyses.
• Prepare TFLs and technical documentation to support IND/CTA, PK Worksheets, Toxicology Worksheets, Clinical Study Reports (CSRs), and Investigator Brochures (IB).
• Collaborate with Scientific Writing and Programming teams to issue study reports in support of regulatory submissions.
• Support the preparation of materials for regulatory interactions, including pre-IND, EOP2, and pre-BLA meetings.
• Serve as the study lead for moderately complex clinical pharmacology projects.

Requirements

• PhD in Biology, Pharmacology, Engineering, or Pharmacy (Pharm.D.), or an MD degree.
• 3+ years of relevant Clinical Pharmacology experience.
• Proficiency in R, R-Studio, Prism, Phoenix WinNonlin, NLME, STAN, and NonMem.
• Strong understanding of advanced pharmacometrics concepts such as nonlinear mixed effects modeling, Bayesian approaches, and QSP.
• Ability to communicate effectively and influence cross-functional team members.

About the Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to translate science into medicine has led to numerous FDA-approved treatments. We are committed to an inclusive culture and an award-winning environment of innovation.