Job Opportunities - OnKure, Inc.
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Head of DMPK

Job Title
Head of DMPK
Job ID
Boulder,  CO
Other Location
OnKure is seeking a head of Drug Metabolism and Pharmacokinetics (DMPK) who will oversee and drive the design and implementation of in vitro and in vivo DMPK strategies to enable the advancement of a range of OnKure targeted therapy oncology programs at various stages of development. 

This role requires direct hands-on contributions, oversight of external vendors, and extensive collaboration across Discovery, Development and the broader industry.  The successful candidate will have significant depth of DMPK knowledge and experience related to small-molecule drug discovery and development, particularly in the area of oncology.

Job Responsibilities
  • In collaboration with internal teams, design, implement and execute DMPK strategies for all OnKure programs to enable efficient advancement of high-quality assets.  Lead the research and resolution of DMPK-related challenges or issues
  • Oversee, tailor and optimize DMPK contracted assays in support of Discovery programs
  • Manage drug-specific pre-IND activities for DMPK based on industry best practices and regulatory guidances; lead and contribute to reports and summary documents for regulatory submissions and required responses
  • Lead the identification and management of DMPK-related researchers, collaborators and vendors to support compound advancement
  • As needs grow, build resources and the DMPK department with consultants, contractors and/or full-time employees as needed
  • Contribute to publications, abstracts and presentations
  • Manage DMPK-related budgets, timelines and deliverables
  • Represent DMPK to senior management and external stakeholders as needed

Preferred Experience and Qualifications:
  • Advanced scientific degree (M.S. or Ph.D.) with a minimum of 10 years of relevant DMPK experience in the pharmaceutical industry, including a minimum of 5 years in a leadership role managing internal staff and resources
  • Deep theoretical and practical knowledge, lab-based experience and hands-on experience with software systems related to all aspects of DMPK.  These include mechanistic metabolism, standard and nonstandard in vitro assays, PK and PK/PD (design, analysis and interpretation), relevant statistics, ADME, DDI risks, TK, bioanalytical and modeling & simulation.​​​​​​\
    • Experience with PBPK modeling and human dose prediction is a plus
    • Breadth of understanding in areas such as toxicology, formulation development, pharmacology, clinical pharmacology and/or medicinal chemistry are also a plus
  • Experience in developing DMPK-related strategies and leading cross-functional teams in the advancement of novel therapeutics
  • Depth of knowledge of the current FDA and ICH requirements and guidances in DMPK
  • Experience writing DMPK-related reports and regulatory summaries in collaboration with cross-functional teams
  • Track record of leadership and issue resolution with stakeholders for complex problems
  • Collaborative and flexible team player who fosters open communication and strong teams
  • Excellent communication, data analysis and organizational skills

About OnKure:
OnKure, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and development of best-in-class precision medicines that target biologically validated drivers of cancer. Using its proven structure-based drug design approach, the Company is building a robust pipeline of tumor-agnostic candidates that are designed to achieve optimal tolerability and efficacy. OnKure is currently developing its lead clinical candidate, OKI-179, an oral, selective Class I HDAC inhibitor, for the treatment of both hematological and solid tumors. 
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. 

The level and annual compensation range for this role, based on experience, is $150,000-$195,000. 

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. ​​​

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