Role Summary
Vice President, Clinical Pharmacology, Pharmacometrics and DMPK responsible for leading and integrating the Clinical Pharmacology, DMPK, and model-informed drug development function within Disc Medicine's R&D strategy. This senior leadership role reports to the Senior Vice President, Early Development and Clinical Pharmacology, and will drive critical development and regulatory decisions across the pipeline. The position is a hybrid role with remote work and the option to be based at the Watertown, MA headquarters.
Responsibilities
- Further establish and lead the Clinical Pharmacology, Pharmacometrics and DMPK function. Define strategic vision, operational frameworks, and best practices tailored to Disc Medicine's portfolio and R&D goals.
- Lead the clinical pharmacology and DMPK on cross-functional R&D teams, contributing to nonclinical and clinical development plans, study protocols, and decision-making at all stages.
- Apply quantitative methodologies including population PK/PD, exposure–response modeling, PBPK, and QSP to inform dose selection, clinical trial design, special population strategies, and regulatory submissions.
- Drive the clinical pharmacology and DMPK strategy for INDs, CTAs, NDAs/BLAs. Oversee related authorship and review of key regulatory documents and engagement with global health authorities.
- Collaborate closely with Clinical Development, Regulatory Affairs, CMC, Innovation, Toxicology, and Biomarker teams to ensure alignment and integration of Clinical Pharmacology and DMPK throughout R&D.
- Maintain expertise in evolving clinical pharmacology and pharmacometrics, and DMPK approaches. Represent Disc Medicine in external scientific forums, regulatory meetings, and industry collaborations.
Qualifications
- PhD or PharmD in Clinical Pharmacology, DMPK, Pharmaceutical Sciences, or a related scientific discipline.
- 20+ years of relevant industry experience, including 10+ years in a leadership capacity within clinical pharmacology and/or DMPK.
- Track record of supporting research and development programs including leading Clinical pharmacology/DMPK in regulatory filings and successful interactions with global health authorities.
- Expertise in a broad range of Clinical Pharmacology and DMPK areas with comprehensive understanding of modeling and simulation methodologies (e.g., popPK, PBPK, exposure–response, QSP).
- Demonstrated ability to work collaboratively in a cross-functional, matrixed environment and to influence at all levels of the organization.
- Excellent communication skills, including the ability to distill complex scientific analyses into clear, actionable recommendations.