Director, Clinical Pharmacology

The role

The Director of Clinical Pharmacology will lead integrated clinical pharmacology strategies for REM-422 and emerging pipeline programs. This role involves designing studies, driving dose optimization, and supporting regulatory submissions.

What you will do

• Lead the integrated clinical pharmacology strategy for REM-422.
• Support late-stage development and potential regulatory submissions.
• Drive dose optimization for REM-422 consistent with FDA Project Optimus expectations.
• Design and oversee clinical pharmacology studies evaluating food effect, drug-drug interactions, absorption and metabolism.
• Represent Clinical Pharmacology in regulatory interactions.
• Lead relevant components of briefing documents and regulatory submissions.
• Provide clinical pharmacology leadership for emerging pipeline programs.
• Support human PK projections, first-in-human dose selection, and dose-escalation design.
• Partner cross-functionally and oversee external vendors.

Required qualifications

• PhD, PharmD, or MD with relevant training in clinical pharmacology, pharmaceutical sciences, or a related discipline.
• 10+ years of clinical pharmacology experience in the biotech or pharmaceutical industry, including oncology and clinical-stage development.
• Demonstrated expertise in clinical pharmacology strategy and study design from early development through registration.
• Direct experience contributing to an NDA/MAA submission, including authoring clinical pharmacology sections of the filing.
• Deep understanding of PK/PD principles, modeling and simulation, and exposure–response analysis.
• Proven cross-functional leadership and ability to integrate complex scientific data into strategic development decisions.
• Excellent communication skills.

Benefits

• Bonus
• Equity
• Benefits

About the company

Remix Therapeutics is a clinical-stage biotechnology company developing novel small molecule therapies designed to reprogram RNA processing and address disease drivers at their origin.