Director/ Associate Director/Principal Investigator - Clinical Pharmacometrics Experts

Clinical Pharmacometrics Experts

My client, a leading Biopharmaceutical company, is looking to grow their clinical Pharmacometrics group. Looking for an Investigator, who will be responsible for performing pharmacometrics modeling and simulations to support early clinical development for biologics and small molecules (PK/PD, (semi-)mechanistic PK/PD, PBPK, and QSP, etc.,)

There are multiple openings in this team, seniority is based on experience,

Positions available: Director, Associate Director, Principal Investigator

Responsibilities

Develop and execute pharmacometrics modeling and simulations strategy

Support clinical development programs, regulatory/submission strategy and related documents working closely with relevant teams.

PK/PD analyses and/or population PK/PD analyses, interpretation and reporting of data.

(semi-)mechanistic PK/PD, PBPK, and/or QSP modeling and simulations to support clinical decision-making.

Presentation of results internally and externally

Your Profile

5+ years = Associate Director/Director

1-5 years = Principal / Senior

PHD (or Equivalent) with Industry experience (years below)Pharmacokinetics, Pharmacometrics, Pharmacology, Pharmaceutical Science, Chemical/Biomedical engineering, Statistics

PK/PD analysis, PBPK, and/or QSP modeling and simulations.

R, NONMEM, Monolix, MatLab, Simcyp, GastroPlus, or other pharmacokinetic, modeling and data visualizations software

Good understanding of biopharmaceutical and ADME properties of both small molecules and biologics

Additional Experience required for a Director application 

Clinical pharmacology, human biomarker validation and development, and Phase 1, first-in-human or proof of concept clinical trials;

Planning, scheduling, and execution of multiple programs and projects

significant and successful contributions to regulatory submissions, such as CTAs and/or NDA/sNDA/MAA