Director, Clinical Pharmacology

Remix Therapeutics•Watertown, MA

4d•$206,000 - $252,000

About The Position

The Director of Clinical Pharmacology will lead the design, execution, analysis, and interpretation of clinical pharmacology strategies across Remix Therapeutics’ development programs. The initial focus is the integrated clinical pharmacology strategy for REM-422, supporting late-stage development and potential regulatory submissions, including a potential NDA. The role will shape dose selection, labeling, and regulatory strategy for an oral RNA-targeting therapy being evaluated in adenoid cystic carcinoma and acute myeloid leukemia/high-risk myelodysplastic syndrome. The Director will also provide clinical pharmacology leadership for emerging pipeline programs, supporting IND-enabling and early clinical development strategies. The role works in a highly cross-functional environment, partnering with Clinical Development, Regulatory Affairs, Clinical Operations, Biostatistics, DMPK, CMC, and external collaborators. It also involves overseeing external vendors and integrating scientific data to support development decisions and advance clinical programs.

Requirements

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, including the ability to present to senior leadership and external stakeholders.

Responsibilities

Lead the integrated clinical pharmacology strategy for REM-422, supporting late-stage development and potential regulatory submissions.
Drive REM-422 dose optimization consistent with FDA Project Optimus expectations, including population PK, exposure–response, and model-informed drug development analyses.
Design and oversee clinical pharmacology studies evaluating food effect, drug–drug interactions, absorption, metabolism, and other intrinsic and extrinsic factors affecting REM-422 exposure.
Represent Clinical Pharmacology in regulatory interactions and lead relevant components of briefing documents and regulatory submissions.
Provide clinical pharmacology leadership for emerging pipeline programs, translating nonclinical pharmacology, ADME, PK, and toxicology data into integrated IND-enabling and early clinical development strategies.
Support human PK projections, first-in-human dose selection, dose-escalation design, PK/PD assessments, and early identification of clinical pharmacology risks.
Partner cross-functionally and oversee external vendors to ensure high-quality, timely delivery of studies, analyses, models, and regulatory documentation.