Senior Clinical Pharmacologist

Job Summary

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.

Work Location

Tarrytown, NY, Warren, NJ, Cambridge, MA
Hybrid: 4 days per week on site

Responsibilities

• Plans, designs, implements and analyzes routine Pharmacometrics (PMx) studies to advance scientific knowledge, in collaboration with other team members.
• Performs analyses such as NCA, compartmental modeling, PopPK, translational modelling, disease modelling, Pop PK/PD, E-R analyses (or work closely with Research Specialist or PMx Stats Programming team) to deliver PMx results, interpretation and discussion.
• Collaborates with Scientific Writing (and where appropriate with PMx Stats Programming team) to ensure TFLs for PMx 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.
• Supports preparation of material to be used in regulatory interactions.
• Contributes to preparation of PMx materials for regulatory background packages, e.g. for pre-IND, EOP2, and pre-BLA meetings.
• Supports preparation of material to be used in regulatory interactions.
• Supports preparation of PMx materials for regulatory background packages, e.g. for pre-IND, EOP2, and pre-BLA meetings.
• Contributes to preparation of PMx materials for regulatory background packages, e.g. for pre-IND, EOP2, and pre-BLA meetings.

Requirements

• PhD in Biology, Pharmacology, Engineering or a Pharmacy (Pharm.D.), Medicine (MD) degree
• 3+ years of relevant Clinical Pharmacology experience

Qualifications

• 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.
• Able to communicate effectively with and influence team members from other functions.
• Fully understand processes and are able to represent PMx on process initiatives.