Note: The job is a remote job and is open to candidates in USA. Entrada Therapeutics is seeking a Clinical Pharmacology Consultant to support its clinical-stage programs with quantitative pharmacology expertise. The role applies model-based drug development and leads clinical pharmacokinetic and pharmacodynamic analysis, interpretation, integration, and reporting while partnering across clinical, statistical, nonclinical, operational, and regulatory functions.

Responsibilities

• Provide clinical pharmacology input to regulatory documents, participate in clinical study design and documentation (lab manuals, protocols, SAPs, etc)
• Independently lead and oversee the analysis, interpretation, integration and reporting of clinical pharmacokinetic & pharmacodynamic data of assigned projects
• Work collaboratively with functional partners, including Clinical Development, Biostatistics, Non-Clinical Product Development, Clinical Operations, and Regulatory to deliver on both project team and corporate objectives
• Monitor work with CROs and other external vendors to ensure compliance with agreed protocols, quality standards, and timelines

Skills

• MS 8+ years or Ph.D. and 3 + years in pharmaceutical sciences, pharmacology, pharmacometrics, pharmacokinetics, or related discipline or Pharm.D. or M.D. with relevant experience
• Experience using Phoenix WinNonlin, R, NONMEM, MATLAB, or other pharmacokinetic and modeling software
• Strong mathematical model development and analytical skills
• Publication record with a demonstrated technical exposure to early exploratory trials through Phase 2/3 programs preferred
• Compartmental PK/PD modeling experience is a plus

Benefits

• This is a US based remote contract position

Company Overview

Company H1B Sponsorship