North AmericaFull TimeEngineering
Remotely
rsimulationpharmacologymodelingpkpdnonmemphoenix winnonlin
Job Description
📋 Description
- Lead clinical pharmacology strategy across Ph1–Ph3 programs.
- Partner with cross-functional teams to support regulatory submissions.
- Oversee PK/PD, exposure–response, modeling and simulation activities.
- Design and manage clinical pharmacology studies and reporting.
- Collaborate with Clinical Development, Regulatory, Biometrics, and others to drive development
- Mentor scientists and contribute to publications and internal knowledge sharing.
🎯 Requirements
- PhD/PharmD/MD or equivalent in related field.
- 10–15+ years pharma/biotech, with 10+ years in Clinical Pharmacology.
- Experience across multiple development stages; familiarity with biologics, peptides, small
- Regulatory submission experience and interactions with FDA/global authorities.
- Strong PK/PD knowledge; experience with population PK and exposure–response analyses.
- Proficiency with NONMEM, Phoenix WinNonlin, R, SAS or similar software.
🎁 Benefits
- Remote work opportunities within the United States; occasional travel to Cambridge, MA.
- Competitive pay range:
$268,000 – $302,000 USD (illustrative).