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Director, DMPK

Gables Search Group
Cambridge, MA Full Time
POSTED ON 4/22/2025
AVAILABLE BEFORE 5/22/2025
Location: Cambridge, MA

My client is seeking a highly skilled and experienced professional to join their research and development team as the Director of Drug Metabolism and Pharmacokinetics (DMPK). This critical role will provide strategic leadership and scientific expertise to support discovery and early clinical development efforts, driving innovation and progress across multiple project teams.

The Director of DMPK will be responsible for designing and overseeing targeted ADME/PK studies to meet key project milestones, facilitating the transition from lead optimization to early-stage development. This role involves analyzing and interpreting preclinical ADME/PK data and effectively communicating findings and recommendations to cross-functional teams. The individual will establish and maintain strong collaborations with internal and external experts in chemistry, biology, pharmacology, and other R&D disciplines. Additionally, they will work closely with discovery and clinical teams to design preclinical studies that inform clinical dosing strategies.

A key aspect of this role includes contributing to strategic decision-making in areas such as candidate selection, development planning, and clinical trial design. The Director will be responsible for authoring and reviewing comprehensive preclinical study reports, including regulatory documentation related to nonclinical toxicology, DMPK, and biomarkers. They will also design and interpret PK/PD, efficacy, and toxicology studies in collaboration with multidisciplinary teams. Keeping up to date with the latest scientific advancements in DMPK and emerging technologies will be essential to optimizing program outcomes. Additionally, the role will involve supporting the finalization of clinical study protocols and reports with a focus on DMPK considerations.

The ideal candidate will hold a PhD or equivalent in a relevant field and have at least seven years of experience in the pharmaceutical or biotechnology industry. A deep understanding of DMPK principles and ADME/PK assays in drug development is required, along with demonstrated expertise in human pharmacokinetics (PK) and dose projections. The candidate must have a proven track record of leadership as a DMPK project representative on multiple project teams, as well as a strong grasp of regulatory guidelines for ADME/PK characterization and human studies. Experience with IND preparation and regulatory documentation is essential.

Exceptional communication and collaboration skills are necessary for conveying ADME/PK risks effectively across teams. Experience with covalent modalities, PROTACs, and parenteral delivery is preferred. The ability to thrive in a cross-functional team environment will be crucial to success in this role.

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