Senior Clinical Pharmacologist

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.

• 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.
• Works (or collaborates with Research Specialist or Programming team) to prepare TFLs to support IND/CTA, PK WSs, Tox WS, Pharm WS, CSRs, DSURs, IB and other documents.
• 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, QC and QAA (as required) to issue study reports in support of IND/CTA submissions and other regulatory documents.
• With close supervision from senior PMx staff, 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.
• Has understanding of advanced PMx concepts and techniques, such as advanced pharmacokinetics, advanced pharmacological principles, non‑compartmental analysis methods, Exposure‑Response analysis methods, translational modelling/pharmacology, Nonlinear Mixed Effects modeling, logistic regression, survival analysis, Bayesian approaches, disease modelling/QSP.
• Is highly skilled in use of relevant software, including MS‑Excel, R, R‑Studio, Prism, Phoenix Win Nonlin, NLME, STAN and Non Mem, working in department computing environment to perform advanced PMx analyses.

• Are able to serve independently as study CP/QP/PPKPD lead for moderately complex studies or support study CP/QP/PPKPD lead for more complex studies, and to contribute to or lead non‑project objectives.
• Are able to communicate effectively with and influence team members from other functions.
• Fully understand processes and are able to represent PMx on process initiatives.
• Beginning to establish own research areas within development sciences.

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