Clinical Pharmacology Consultant

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Offer clinical pharmacology insights for regulatory documentation.

• Engage in the design and documentation of clinical studies, which includes lab manuals, study protocols, and statistical analysis plans (SAPs).

• Take the lead in analyzing, interpreting, integrating, and reporting clinical pharmacokinetic and pharmacodynamic data for assigned projects independently.

• Work collaboratively with Clinical Development, Biostatistics, Non-Clinical Product Development, Clinical Operations, and Regulatory teams.

• Supervise CRO and external vendor activities to ensure adherence to protocols, quality standards, and timelines.

• Report directly to the Head of Clinical Pharmacology.

⛳️ Requirements

• MS with over 8 years of experience or a Ph.D. with more than 3 years in pharmaceutical sciences, pharmacology, pharmacometrics, pharmacokinetics, or a related field, or a Pharm.D. or M.D. with relevant experience.

• A publication history showcasing technical expertise in early exploratory trials through Phase 2/3 programs is preferred.

• Proficient in using Phoenix WinNonlin, R, NONMEM, MATLAB, or other pharmacokinetic and modeling software.

• Experience in compartmental PK/PD modeling is an added advantage.

• Excellent skills in mathematical model development and analysis.

🏝️ Benefits

• Contract position.

• Flexible remote work arrangement.

• Support for 30–40 hours per week.