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. Remix's REMaster™ technology platform leverages data science, biomolecular sciences and chemistry approaches to identify orally administered compounds that modulate gene expression. Remix's therapeutic approach led to the discovery of REM-422, an investigational small molecule designed to modulate RNA processing in oncology, currently being evaluated in two clinical programs, 1) the ARIA clinical study, a Phase 1/2 clinical study in adenoid cystic carcinoma (ACC), and 2) a Phase 1 clinical study in acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (HR-MDS).
Position Summary:
The Director of Clinical Pharmacology will play a critical role in the design, execution, analysis, and interpretation of clinical pharmacology strategies across Remix Therapeutics' development programs. The initial focus of the role will be to lead the integrated clinical pharmacology strategy for REM-422, with primary responsibility for supporting late-stage development and potential regulatory submissions. The role will also provide clinical pharmacology leadership for emerging pipeline programs to support IND-enabling and early clinical development strategies.
The successful candidate will work in a highly cross-functional environment, partnering closely with Clinical Development, Regulatory Affairs, Clinical Operations, Biostatistics, DMPK, CMC and external collaborators to drive data-driven decision making and advance clinical development.
This is an opportunity to own the clinical pharmacology strategy for REM-422 as it advances toward a potential NDA, which would be Remix's first. You will shape dose selection, labeling, and regulatory strategy for an oral RNA-targeting therapy in ACC and AML/HR-MDS, and set the clinical pharmacology approach for the pipeline programs coming behind it.
Key Responsibilities:
- Lead the integrated clinical pharmacology strategy for REM-422, with primary responsibility for supporting late-stage development and potential regulatory submissions.
- Drive dose optimization for REM-422 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 and 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.
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, with the ability to present to senior leadership and external stakeholders.
Salary Range:
$206,000 - $252,000 USD
This range reflects the expected base salary for this position, plus bonus, equity, and benefits as applicable. Actual salaries may vary based on factors, such as skill, experience, and qualification for the role.