Head of DMPK
- Job Title
- Head of DMPK
- Job ID
- Boulder, CO
- Other Location
The Associate Director / Director / Senior Director, DMPK will provide DMPK leadership in the design, implementation, oversight, analysis, and reporting of DMPK studies that support small molecule drug discovery and development teams. The ideal candidate will provide key internal support and oversee the work of CROs to perform in vitro and in vivo DMPK/ADME studies that comply with regulatory guidelines to support discovery and development projects.
Additionally, the candidate will oversee the preparation of nonclinical and clinical DMPK reports and relevant components of regulatory submissions, including IND, NDA/BLA.
What You Will Achieve:
Responsible for leading the technical, scientific, and strategic efforts to support DMPK activities for OnKure’s leading drug, OKI-179, currently in Phase 2
- Provide tactical strategic input into the design and implementation of DMPK endpoints in clinical studies, including the design of specialty studies where appropriate to support development studies and regulatory filings
- Identify needed external partners and initiate and manage contracts with CROs, contractors and academic partners to ensure timely and effective delivery of DMPK and clinical pharmacology support for development compounds
- Provide critical analysis of clinical DMPK data and lead the design and implementation of non-clinical and clinical studies to enable the characterization and understanding of the ADME/PK characteristics of development compounds.
- Participate in the preparation of nonclinical DMPK/ADME reports and the relevant sections of documents for regulatory submissions (IND, CSR, annual reports etc)
- Provide technical, scientific, and strategic leadership to support DMPK activities for OnKure’s emerging discovery pipeline
- Collaborate effectively with CROs and internal staff to design and execute in vitro and in vivo DMPK/ADME studies to support and guide the optimization of discovery compounds and characterization of drug candidates
- Design and implement PK/TK aspects of nonclinical pharmacology and nonclinical toxicology studies ensuring studies are rigorously designed and comply with appropriate regulatory guidance (GLP, ICH, etc.)
- Effectively communicate DMPK data and provide interpretation of results to project teams, senior management, and regulatory authorities
- Participate in the assessment of in-licensing opportunities when required
- PhD in chemistry, biological sciences, pharmacology, or a related scientific discipline
- Comprehensive understanding and scientific knowledge of DMPK/ADME, PK/PD and drug development processes, that support the characterization of safety and efficacy of oncology therapeuticsHands-on knowledge of WinNonlin for PKPD analysis
- IND/other regulatory filing experience
- 8-12 years of relevant experience in the pharmaceutical or biotechnology industry, demonstrating a broad understanding of drug development
- Ability to work independently, and engage and influence others in the team
- Proven ability to manage CROs
- Excellent written and oral communication skills, including in writing key development documentation (IND, CSR, NDA)
- Ability to think critically and solve problems independently
- Ability to navigate and work effectively in a fast-paced, matrix-team work environment
OnKure, Inc. is a private biotech company, based in Boulder, Colorado. The company was founded and is led by several scientific leaders from Array BioPharma, another Boulder-based company. Our mission is to create novel, high quality drugs to provide meaningful therapy for cancer patients. Our near-term goals are to advance our clinical stage drug, OKI-179, into several Phase 2 clinical trials, build a state-of-the-art drug discovery group and establish a robust pipeline of projects and development candidates.
Our Boulder facilities feature modern offices, and new laboratories are under construction. With the mountains at our doorstep, great schools, cultural and unparalleled outdoor activities, Boulder is the No. 1 place to live out of the 150 most populous metro areas in the U.S. for the second year in a row!
To attract the very best talent, OnKure offers a generous compensation and benefits package that includes competitive pay, performance-based bonus opportunities, stock options, insurance coverage (health, dental, life, and disability), self-managed paid time off, and a 401(k) plan with company match. We operate on a flexible schedule that allows a combination of both in-office and home-based work.
Annual compensation range for this role, based on experience is $150,000 - $225,000.
OnKure is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected factors.