Director of DMPK

Position Overview

We are seeking a highly motivated and scientifically driven Director of DMPK to lead DMPK strategy and execution. This individual will serve as the functional lead for DMPK activities spanning discovery through early clinical development and will be accountable for the design, oversight, and interpretation of ADME and PK studies supporting IND-enabling packages. The ideal candidate combines strategic scientific leadership with a willingness to remain hands-on in the lab, supporting in vitro and in vivo DMPK studies as needed.

Key Responsibilities

• Provide strategic and scientific leadership for all DMPK activities supporting the small molecule oncology pipeline.
• Design, interpret, and integrate ADME and PK studies in support of compound optimization, candidate selection, and regulatory submissions.
• Oversee the generation, analysis, and presentation of preclinical PK and metabolism data to project teams, senior leadership, and regulatory authorities.
• Author and/or review relevant IND sections (Modules 2.6.4 and 2.6.5), ensuring high-quality data packages and regulatory compliance.
• Collaborate cross-functionally with discovery biology, medicinal chemistry, toxicology, and clinical pharmacology to define DMPK strategies that support effective translational plans.
• Manage CROs conducting in vitro/in vivo ADME, bioanalytical, and metabolite identification studies; ensure scientific quality, compliance, and timelines.
• Remain actively engaged in laboratory work—supporting method development, in vitro ADME assays, and data review—as needed for program advancement.
• Represent DMPK in regulatory interactions and cross-functional governance meetings.
• Mentor junior scientists and foster a culture of scientific rigor, collaboration, and continuous learning.

Qualifications

• Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, Drug Metabolism, or related field with 10 years of industry experience in DMPK, preferably in oncology-focused small molecule development.
• Proven track record of success supporting IND and early clinical development, including authorship or major contribution to Modules 2.6.4 and 2.6.5.
• Strong expertise in in vitro and in vivo ADME, PK/PD modeling, and data integration for compound optimization.
• Comfortable and competent in a hands-on lab environment; able to support key in vitro ADME and bioanalytical activities as needed.
• Experience managing external CROs and ensuring scientific and operational excellence.
• Excellent cross-functional communication and leadership skills.
• Ability to thrive in a dynamic, fast-paced, and collaborative biotech environment.

Preferred Experience

• Experience in oncology or targeted small molecule therapies.
• Familiarity with mechanistic PK modeling, PBPK, and translational approaches.
• Prior involvement with FIH dose projection and clinical pharmacology interface.
• Experience in both large pharma and small biotech settings is advantageous.