Director, Clinical Pharmacology — Oncology NDA Strategy

Remix Therapeutics; Watertown (MA); On-site; USD 206,000 - 252,000; Full time

Job summary

Remix Therapeutics is seeking a Director of Clinical Pharmacology to lead the integrated strategy for REM-422 and support late-stage development and potential NDA submissions. You will shape dose selection, regulatory strategy, and cross-functional leadership across development programs.

The role involves collaboration with Regulatory Affairs, Clinical Operations, Biostatistics, and external partners to drive data-driven decisions and advance clinical development toward an NDA.

Qualifications

• PhD, PharmD, or MD with clinical pharmacology training.
• 10+ years in biotech/pharma clinical pharmacology, oncology experience.
• Experience contributing to NDA/MAA submissions and drafting sections.
• Deep PK/PD, modeling, and exposure–response knowledge.
• Strong cross-functional leadership and communication.

Responsibilities

• Lead the integrated clinical pharmacology strategy for REM-422 and late-stage development.
• Drive dose optimization and regulator-aligned development plans.
• Design and oversee studies on food effect, DDIs, absorption/metabolism, and exposure.
• Represent Clinical Pharmacology in regulatory interactions and submissions.
• Provide leadership for pipeline programs translating nonclinical data into development plans.
• Support human PK projections and first-in-human dose selection.
• Oversee external vendors to ensure timely, high-quality deliverables.

Skills

Clinical pharmacology strategy

Cross-functional leadership

Regulatory submissions

PK/PD modeling

Drug development strategy

Education

PhD, PharmD, or MD

Tools

NONMEM

Phoenix WinNonlin

SAS

Job description

Remix Therapeutics is seeking a Director of Clinical Pharmacology to lead the integrated strategy for REM-422 and support late-stage development and potential NDA submissions. You will shape dose selection, regulatory strategy, and cross-functional leadership across development programs.

The role involves collaboration with Regulatory Affairs, Clinical Operations, Biostatistics, and external partners to drive data-driven decisions and advance clinical development toward an NDA.