About the role
The Associate Director/Director, DMPK is responsible for overseeing nonclinical drug metabolism and pharmacokinetic (DMPK) studies to advance small molecule drug candidates from preclinical through clinical development. The ability to plan, execute, monitor, and interpret DMPK studies for advancing therapeutic candidates through all stages of discovery and development are crucial elements of this position. While the focus of this role will largely be on preclinical drug discovery activities, there may be some involvement with the development of nonclinical sections for IND, IB, and NDA submissions. Excellent interpersonal and communication skills are essential in this highly visible role to work effectively within the cross-functional program teams.
- Partner with medicinal chemists, biologists, and data scientists to contribute to optimization and the identification of high-quality development candidates.
- Provide input for addressing ADME issues in lead compounds and lead series in drug discovery.
- Design and oversee external preclinical DMPK studies to understand pharmacokinetics (PK) and absorption, metabolism, distribution, excretion (ADME), and in vitro drug-drug interaction properties of lead compounds.
- Build and provide predictions of human PK and pharmacologically active dose based on nonclinical data.
- Represent DMPK as a subject matter expert to project teams by interpreting PK results to cross-functional program teams and contribute to the ADME section of IND filings.
- Directly interface with and manage contract research organizations (CROs) running PK studies – including gathering quotes and deriving cost estimates, providing input during protocol development, monitoring timelines and data quality, and reviewing data and study activities.
- Maintain a current understanding of DMPK literature, methodology and regulatory requirements.
- May manage a team of scientists supporting DMPK activities.
- D. pharmacokinetic/pharmaceutic science or related discipline or B.S./M.S. with extensive experience.
- 8-10+ years of industry experience contributing DMPK/ADME data to project teams as a DMPK Project Team Lead/Core Team Member that enabled decisions.
- Experience selecting and managing CROs
- Experience in working with Drug Discovery teams on development of efficacy models to support understanding of PK/PD relationships, and application to clinical biomarker development with clinical pharmacology team
- Excellent project, time management, problem solving skills and ability to work and lead in a cross-functional setting.
- Strong communication, interpersonal, collaboration and multi-tasking skills are required
- Excellent knowledge and hands-on skills building translational PK/PD models is highly desirable
- Experience with PK/PD and Modeling software (e.g., Phoenix WinNonLin, MATLAB/ Simbiology, PK Sim, Simcyp, or, background using NONMEM to develop PK/PD models) for optimization and selection of development candidates.
- Experience in contributing to IND-enabling documents desirable.
Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters)
The Human Resources team manages the recruitment and employment process for Treeline Biosciences. To protect the interests of all parties involved, Treeline Biosciences will only accept resumes from a recruiter if an executed search agreement directed to the particular position or positions is in place at the start of the recruitment effort. Unsolicited resumes sent to Treeline Biosciences from recruiters do not constitute any type of relationship between the recruiter and Treeline Biosciences and do not obligate Treeline Biosciences in any way to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.