Flatiron Health is looking for a Senior Manager of Regulatory Program Operations to join our growing Regulatory Policy team. This team is responsible for driving forward our growing body of work with our regulatory partners, which is increasingly strategically critical to truly moving the needle on Flatiron’s mission.

The responsibilities of this role will include overseeing the execution of projects done in collaboration with regulatory bodies, as well as serving as a cross-functional bridge internally at Flatiron across the project teams executing the work. This job requires an analytical mind, client management and organizational skills, and excitement to build something from the ground up. A successful candidate will get to take part in a collaborative, high-profile, multi-stakeholder team focused on shaping novel use cases for real-world data and other Flatiron solutions, helping to tackle one of the most complex medical and technological challenges of our time.

Responsibilities:

• Support Director, Regulatory Policy in researching, crafting, and disseminating Flatiron’s Real-World Evidence Policy positioning (e.g., white papers, Comments)
• Drive internal collaboration with cross-functional project teams, including Research Oncology, Quantitative Sciences, and Operations, while maintaining end-to-end timelines and project plans
• Play life sciences relationship management role with FDA, NCI, FOCR and others
• Serve as Flatiron’s primary regulatory agency liaison for new regulatory-focused projects and cross-functional initiatives
• Lead problem-solving discussions with internal and external stakeholders (e.g., Life Sciences Partnerships, Research Oncology, Clinical Data Abstraction, Product, Engineering, and Quantitative Sciences) to ensure that all necessary inputs are considered and the team collectively makes clinically and scientifically sound decisions
• Lead or support meetings and engagements with external stakeholders (e.g., Life Sciences companies and Academic Research Centers)
• Track and communicate progress and decisions clearly and regularly to internal and external stakeholders
• Triage issues to the appropriate internal stakeholder and ensure timely effective issue resolution
• 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
• Own Flatiron’s preparation for and participation at relevant regulatory-focused conferences and workshops (e.g., slide creation, speaker prep, attendee management, transmission of learnings post-event)
• Stay up to date on official FDA communications for relevance to Flatiron’s RWE business

Requirements:

• Bachelor’s degree or equivalent experience
• Spike in project management and communication skills
• Experience working on cross-functional teams
• Experience with or deep understanding of scientific methodologies or statistics
• Work experience in one of the following types of highly structured or scientific environments: academic hospital, management/healthcare consulting, research foundation, or CRO/ARO
• The ability to juggle multiple client interactions and deadlines simultaneously and the versatility to collaborate with individuals at all levels and across various functions within regulatory and life sciences firms
• Passion to fight cancer
• Open to semi-frequent travel (1-2 times per month) to DC

Bonus Points:

• Health policy knowledge
• Experience managing a small team
• Background as government affairs professional in health sector
• Experience in epidemiological or outcomes research (real-world evidence)
• Advanced degree: MBA, MPH, MS, PhD