Senior Clinical Pharmacologist

Regeneron Pharmaceuticals•Warren, MA

11d•Onsite

About The Position

As a Senior Clinical Pharmacologist, this individual is expected to plan, design, implement, and analyze in-vivo and in-vitro pharmacokinetic & pharmacodynamic studies, working with Clinical Pharmacology, Quantitative Pharmacology, Pharmacometrics/Pharmacodynamics (PK/PD), Toxicology, Bioanalytical, Therapeutic Focus areas, and Clinical Development/Regulatory Affairs teams. This individual contributes to the scientific understanding of PK/PD for assigned projects, based on quantitative evaluation of the pharmacokinetic and pharmacodynamic profile for research programs, through the application of state-of-the-art knowledge in pharmacokinetics and pharmacodynamics.

Requirements

A PhD in Biology, Pharmacology, Engineering or a Pharmacy (Pharm.D.), Medicine (MD) degree and at least 3+ years of relevant Clinical Pharmacology experience.
Are able to serve independently as study Clinical Pharmacology/Quantitative Pharmacology/PPKPD lead for moderately complex studies.
Highly skilled in use of relevant software, including MS-Excel, R, R-Studio, Prism, Phoenix WinNonlin, NLME, STAN and NonMem, working in department computing environment to perform advanced PMx analyses.

Responsibilities

Plans, designs, implements and analyzes routine Pharmacometrics (PMx) studies to advance scientific knowledge, in collaboration with other team members.
Performs analyses such as compartmental modeling, PopPK, translational modelling, disease modelling, Pop PK/PD, E-R analyses (or work closely with Research Specialist or Pharmacometrics Stats Programming team) to deliver Pharmacometrics results, interpretation and discussion.
Collaborates with Scientific Writing (and where appropriate with Pharmacometrics Stats Programming team) to ensure TFLs for Pharmacometrics reports are complete.
Works in conjunction with Scientific Writing, Quality Control and QAA (as required) to issue study reports in support of IND/CTA submissions and other regulatory documents.
With close supervision from senior Pharmacometrics staff, supports preparation of material to be used in regulatory interactions.
Contributes to preparation of Pharmacometrics materials for regulatory background packages, e.g. for pre-IND, EOP2, and pre-BLA meetings.