Associate Director/Director, DMPK

4 weeks ago

San Diego, California, United States Treeline Biosciences Full time

Associate Director/Director, DMPK:

About the role

The Director, DMPK is responsible for overseeing 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. The Director DMPK will also be responsible for authoring relevant sections of key regulatory documents and should have a strong knowledge of best regulatory practices. Excellent interpersonal and communication skills are essential in this highly visible role to work effectively within the cross-functional program teams.

Responsibilities

  • 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 and presenting conclusions to cross-functional program teams
  • Contribute to Module 2 and Module 4 sections of IND filings as well as IB and protocol
  • Directly interface with and manage contract research organizations (CROs) running PK and ADME studies, including gathering quotes, providing input during protocol development, monitoring timelines and data quality, reviewing data and study activities, and presenting data and conclusions to project teams
  • Maintain a current understanding of DMPK literature, methodology and regulatory requirements.
  • Participate on cross-functional project teams and contribute to interactions with global health authorities

Required Qualifications

  • D. pharmacokinetic/pharmaceutic science or related discipline or B.S./M.S. with extensive experience.
  • 8-10+ years of industry experience contributing DMPK/ADME insights to project teams and leading ADME/PK strategic decisions.
  • Experience selecting and managing CROs
  • Experience with preparation of the DMPK portions of regulatory documents such as pre-IND, IND, IB, briefing documents, and CTA while working in collaboration with cross functional team
  • Strong understanding of DMPK principles, the drug development process, and regulatory guidance to support DMPK and early clinical pharmacology strategies
  • Excellent time management, problem solving skills and ability to work and lead in a cross-functional setting.
  • Ability to exercise good judgment, strong analytical and organization skills, and attention to detail required.
  • Strong communication, interpersonal, collaboration and multi-tasking skills are required

Preferred Qualifications

  • 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.

Treeline Biosciences is committed to protecting the health and safety of our team. Our company requires all employees to be fully vaccinated against COVID-19, including a booster shoot. Proof of vaccination must be provided prior to the first day of employment. As required by applicable law, Treeline will consider requests for Reasonable Accommodations.

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.


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