Flatiron Health is looking for a Director of Regulatory Policy who is excited about changing the world of oncology and healthcare. This role will be responsible for informing and executing regulatory policy strategy at Flatiron. This includes serving as a bridge to healthcare, pharmaceutical and medical device regulatory bodies, such as the FDA, CMS, and Capitol Hill broadly to help guide the development of various healthcare policies such as that focused on development and use of real-world evidence. This job requires a sharp analytical mind, client management and organizational skills, an entrepreneurial spirit, and a passion for tackling one of the most complex medical and technological challenges of our time. This work is being conducted in partnership with regulators and other national stakeholders, so a successful candidate must be excited to be a part of a collaborative multi-stakeholder team focused on moving the needle in how to use real-world data and other Flatiron solutions for new purposes.

Responsibilities

• Work together with regulatory bodies, health policy stakeholders, life science clients, and the Flatiron team to advance guidelines for the use of real-world evidence and the corresponding data quality requirements.
• Subject matter expert in policy and regulatory issues that affect the Flatiron Health business
• Serve as Flatiron’s primary regulatory agency liaison for new regulatory-focused projects and cross-functional initiatives.
• Owns stakeholder strategy and manages relationships with patient advocates, academics, and others.
• Cultivate close partnerships between Flatiron and both domestic and international regulatory agencies, such as the FDA and NCI.
• Collaborate closely with life science partners on joint advocacy.
• Serve as Flatiron’s internal regulatory policy resource and interface with internal and external stakeholders regularly to provide updates and answer project-related questions.
• Partner with Flatiron’s Life Sciences and Project Leadership teams and our clients to scope new projects with regulatory use cases.
• Collaborate and reliably share feedback from regulatory bodies and clients with Flatiron’s team of product managers, engineers, business development leaders, and other cross-functional colleagues.
• Responsible for day to day relationships with stakeholder organizations.

Requirements

• Bachelors degree. Advanced MBA, MHA, MPH, MS, PhD is a plus
• Background as government affairs professional in health sector and/or with direct experience in FDA (preferably), CMS, or equivalent
• Health policy expertise and relationships strongly preferred
• A keen understanding of the FDA and similar regulatory bodies
• Meaningful experience working with data, real-world evidence, and potential applications for clinical research and safety surveillance
• Familiarity with oncology and the regulatory issues that are of particular interest in oncology
• A track record of success in developing long-term relationships with regulatory agencies and life science partners in a strategic and abstract space
• Understanding of the common challenges faced by healthcare providers and life sciences firms and have experience bringing about mutually beneficial solutions
• Flexibility with a startup mindset, and enjoyment of a fast-paced environment
• The ability to juggle multiple client interactions and deadlines simultaneously and the the versatility to collaborate with individuals at all levels and across various functions within regulatory and life sciences firms
• Exceptional written and communication skills and experience owning high profile client relationships
• Superb project management and communication skills
• Experience working on cross-functional teams
• Open to frequent travel (2-3 times per month) to DC

Bonus Points

• Experience with clinical research, especially in the clinical trials or real-world data setting(s)
• Deep oncology expertise