Job Title: Director of DMPK
Job Number: 33933
Location: Watertown, MA
The Director of DMPK is a driven, cooperative, and creative professional who possesses expertise in guiding both nonclinical and clinical DMPK endeavors. They work in close partnership with IND enabling project teams and are responsible for formulating and implementing the essential DMPK and PKPD strategies required to enhance and expedite the progression of candidate molecules in the fields of oncology and immunology towards Clinical Development.
- In close collaboration with medicinal chemists, pharmacologists, and toxicologists within the drug discovery field, this individual holds the responsibility of representing DMPK across a range of projects, spanning from identifying potential targets to selecting candidates, and ultimately preparing them for regulatory submission.
- Partner with in-vivo pharmacology and toxicology experts to design experiments aimed at comprehending preclinical pharmacokinetic/pharmacodynamic (PK/PD) relationships and projecting efficacious human doses.
- The development and execution of the appropriate DMPK strategy as well as the design of nonclinical studies and the presentation of data at multifunctional project teams.
- Actively engage in DMPK-related activities, including interactions with external Contract Research Organizations (CROs) and internal project stakeholders, all while ensuring the high-quality execution of studies within the defined program timelines.
- Collaborate with other core disciplines to bolster the advancement of compounds, focusing on optimizing DMPK properties, both in terms of drug metabolism (DME) and pharmacokinetics (PK), and providing support for activities related to Investigational New Drug (IND) enabling.
- Compose and review of DMPK sections for regulatory submissions, as well as the responsiveness to queries posed by regulatory agencies.
- Ph.D. in a scientific field, such as drug metabolism, pharmacology, or pharmaceutical sciences, with a minimum of 8-10 years of industry experience dedicated to supporting DMPK functions within the context of drug discovery.
- History of actively participating in DMPK-driven drug discovery and/or development projects in a role as a DMPK representative.
- Demonstrate knowledge of drug metabolism, ADME (Absorption, Distribution, Metabolism, Excretion) principles, and DMPK science.
- Expertise in areas including pharmacokinetics (PK), PK/PD (Pharmacokinetics/Pharmacodynamics), risk assessment for drug-drug interactions (DDIs), and the modeling of projected human doses.
- Prior involvement in the preparation and submission of Investigational New Drug (IND) applications, underscoring regulatory familiarity.