Location
Head of Regulatory Affairs (Director/VP)
- Job Title
- Head of Regulatory Affairs (Director/VP)
- Job ID
- 27674866
- Location
- Boulder, CO
- Other Location
- Description
-
OnKure is seeking a hands-on head of Regulatory Affairs who will bring a broad experience in oncology regulatory affairs and operations along with a roll up the sleeves approach to establish and grow an in-house regulatory function and drive the successful development of an innovative pipeline of novel small molecule oncology targeted therapies.
OnKure is a small, growing biotech company, with a driven, interactive, and science-first culture. The ideal candidate will bring a high level of independence, a get things done attitude, and the ability to apply their experience to manage risk and drive programs forward in a small-company environment.
Job Responsibilities:- Build and lead the Regulatory (Regulatory affairs and operations) function enabling the measured growth and evolution from a fully outsourced model as the company and pipeline grows
- Optimize CRO interactions and lead external regulatory CROs and vendors to drive excellence and meet phase appropriate regulations and timelines
- Develop and manage Regulatory budgets
- Develop plans for growth of the regulatory function and hire, manage, and develop Regulatory personnel
- Develop and implement regulatory strategy across a growing pipeline of early- and mid-stage development programs, with a focus on the successful registration of these products
- Enable creative solutions to regulatory challenges to efficiently advance novel cancer therapeutics to key development milestones including positioning for successful pivotal trials and registration
- Ensure effective risk management and communication of issues/risks across the portfolio, and participate in driving prioritization of resource and spend
- Plan, oversee and participate in all regulatory activities, including regulatory submissions (INDs, NDAs, MAAs, CTAs etc), preparation and leading of agency meetings
- Serve as the company contact with the FDA and other regulatory authorities
- Direct and assist internal staff and consultants, to ensure the compliance of R&D activities with U.S. and international requirements
- Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations
- Bachelor’s or more advanced degree in a scientific discipline
- 12+ years of regulatory experience in the pharmaceutical or biotech industry. Experience in leading decision-making and working in small biotech environment is highly preferred
- Oncology drug development experience required with a track record of successful regulatory filings, leading regulatory authority interactions and NDA filings
- Expert knowledge of US regulations, particularly in oncology drug development required. Experience and knowledge in best practices and standards in EU and Asia Pacific regulatory requirements highly desired
- Solid experience with CMC, clinical, and nonclinical development and Regulatory submissions
- A commitment to excellence putting the science and the patients first
- Must be a self-motivated, independent, influential leader who understands risk and risk management in a small company environment
- Possesses a cross-functional collaborative skill set and brings strong analytical thinking and strategic perspective
- Comfortable with owning and decision making within the scope of regulatory affairs and operations
- Thrives in a driven, interactive environment that challenges each other to drive to optimize the discovery and development of medicines that transform the lives of patients with 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), 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 $165,000-$285,000.
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. - Build and lead the Regulatory (Regulatory affairs and operations) function enabling the measured growth and evolution from a fully outsourced model as the company and pipeline grows