USNLX Diversity Jobs

USNLX Diversity Careers

Job Information

OnKure, Inc. Senior Director, Drug Metabolism and Pharmacokinetics in Boulder, Colorado

Position Description: The Senior Director, Drug Metabolism and Pharmacokinetics (DMPK) 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 functions. The successful candidate will have significant depth of DMPK knowledge and experience related to small-molecule drug discovery and development, particularly around 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 guidance; 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 guidance 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 precision medicines that target biologically validated drivers of cancers that are underserved by available therapies. Using a structure- and computational chemistry-driven drug design platform, OnKure is committed to improving clinical outcomes for patients by building a robust pipeline of small molecule drugs designed to selectively target specific mutations thought to be key drivers of cancer. 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) for full-time employees, self-managed paid time off, and a 401(k) plan with company match. Candidates who live in or are willing to relocate to the Boulder, CO area are preferred. The expected annual compensation range for this role, based on experience, is $250,000-$275,000. OnKure is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, protected veteran status, disability, or any other protected factors. ​​​

DirectEmployers