Demo

Senior Clinical Pharmacology Manager

GForce Life Sciences
Watertown, MA Full Time
POSTED ON 3/27/2025
AVAILABLE BEFORE 6/24/2025

Responsibilities:

  • Clinical Pharmacology Support
  • Assist in managing clinical pharmacology (Clin Pharm) studies, including study design, execution, and analysis.
  • Support first-in-human studies, phase 2, and phase 3 trials.
  • Help oversee PK/PD assessments and regulatory documentation.
  • Modeling & Data Analysis
  • Perform exploratory pharmacokinetic (PK) and pharmacodynamic (PD) modeling.
  • Work with clinical pharmacology vendors to ensure data accuracy and integrity.
  • Utilize software like NONMEM or other pharmacometric tools (a plus, but not mandatory). NONMEM is a nonlinear mixed-effects modeling software widely used in pharmacology, particularly for population pharmacokinetic and pharmacodynamic analysis, allowing for the estimation of parameters and their statistical uncertainties to best fit model predictions to observed data
  • Operational & Documentation Support
  • Assist with developing clinical pharmacology templates and literature databases.
  • Support the structuring of departmental workflows and best practices.
  • Interact with vendors, including bioanalytical and modeling CROs.

Requirements:

  • PharmD or PhD in a relevant field (e.g., Pharmaceutics, Clinical Pharmacology, Pharmacokinetics).
  • 2-5 years in clinical pharmacology, PK/PD, or pharmacometrics within the biopharma industry.
  • Must have industry experience (CRO background acceptable)
  • Experience running or supporting clinical pharmacology trials.
  • Some exposure to modeling & simulation (does not need to be an expert).
  • Strong organizational skills to assist with department structuring.
  • Comfortable interfacing with vendors (bioanalytical, modeling).

Start & Terms:

  • Fully remote
  • Full-time, 40 hours/week
  • 12 month contract, open to conversion
  • Health benefits available (health, dental and vision insurance)
  • Rate varies depending on years of experience

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