Location
Head of Translational Medicine - Biomarkers & CDx
- Job Title
- Head of Translational Medicine - Biomarkers & CDx
- Job ID
- 27695622
- Location
- Boulder, CO
- Other Location
- Description
-
OnKure is seeking a Head of Translational Medicine (TM) who will be accountable for overseeing and driving the design and implementation of biomarker and patient selection strategies to enable effective clinical decision making across a range of targeted therapy oncology programs. The candidate will also be responsible for the selection, development and approval of clinical companion diagnostics (CDx) for relevant programs. 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 experience in all phases of cancer drug development with a track record of successful development and implementation of clinically useful PD biomarkers, and in the design and implementation of CDx PMAs.
Responsibilities- Design, implement and execute clinical biomarker (PD) and CDx strategies for all OnKure programs to enable timely and successful clinical decisions and regulatory approvals
- Collaborate with Clinical and Discovery research groups to develop a science-based understanding of the target and clinical strategy based on appropriate preclinical studies that support the development and integration of clinical biomarkers into clinical protocols
- Working with Regulatory, drive the overall regulatory strategy for CDx and biomarkers, and oversee the biomarker/CDx content of all key clinical and regulatory documents
- Contribute to the development of publications, abstracts and presentations
- Lead the identification and ongoing management of collaborators and vendors to support implementation and timely analysis of PD and CDx markers
- As OnKure grows, build the TM department, ensuring adequate resourcing by anticipating needs in advance and filling gaps, as needed, with consultants, contractors and/or full-time employees
- Work with Finance and executive leadership to set budgets, timelines, and deliverables and manage to budget
- Advanced scientific degree (Ph.D., Pharm.D.), with minimum 15 years of relevant work experience developing biomarkers
- Minimum of 5+ years in a leadership role developing translational medicine strategies and managing internal and external teams to enable execution
- Direct knowledge of the regulatory environment in CDx
- Experience developing and documenting biomarker-related clinical and regulatory strategies in coordination with clinical plans and marketing objectives
- Experience developing strategies and leading teams through interactions with relevant health authorities in CDER and CDRH in the US and relevant health authority personnel outside the US
- Experience participating in and leading PMA approval is desired
- Track record of proactively identifying and resolving issues with relevant clinical and/or regulatory stakeholders
- Experience working with discovery stakeholders to guide marker selection, and developing and implementing PD biomarkers in early-stage oncology drug development to support demonstration of mechanism of action and dose/schedule selection
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
- Excellent communication, analytical and organizational skills
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, Parental Leave, 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 $180,000-$215,000.
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.