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Disc Medicine · 3 months ago

Vice President, Clinical Pharmacology, Pharmacometrics and DMPK

Massachusetts - Hybrid

Full-time

Hybrid

Director/Executive

20+ years exp

Disc Medicine is a clinical-stage biopharmaceutical company focused on developing novel treatments for serious hematologic diseases. The Vice President of Clinical Pharmacology, Pharmacometrics and DMPK will lead the integration of these functions into the R&D strategy and drive critical development and regulatory decisions across the pipeline.

BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics

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

Qualification

Clinical PharmacologyDMPKPharmaceutical SciencesModelingSimulationRegulatory FilingsLeadership ExperienceCollaborationCommunication Skills

Required

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 understand of the applications 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