[Please note that this is an office based position at Flatiron's office in New York, NY]
Flatiron Health is a healthcare technology and services company focused on accelerating cancer research and improving patient care. Our platform enables cancer researchers and healthcare providers to learn from the experiences of every patient. In order to advance this mission, Flatiron Health’s Regulatory Policy team facilitates strategic engagement with government agencies, industry groups, patient advocates, scientific thought leaders, academia, life science partners, etc.
In order to support regulatory policy engagement, Flatiron Health works with policy stakeholders to design, review, implement, deliver, and publish demonstration projects leveraging real-world data. To that end, Flatiron Health is seeking an experienced Program Manager to oversee these demonstration projects and support the broader regulatory policy roadmap. This position will be accountable for program management throughout the lifecycle of demonstration projects, including but not limited to coordinating cross-functional internal project teams, facilitating communication with external stakeholders, timeline management, issue management, etc. In addition to supporting demonstration projects, this position will provide flexible support across the regulatory policy roadmap (e.g., regulatory intelligence/ surveillance, stakeholder relationship development, policy meeting management, policy communications). This role will act as a the cross-functional bridge between Flatiron Health staff in New York and policy stakeholders outside of New York (e.g., Washington DC).
Responsibilities:
- Provide proactive project management oversight for multiple concurrent demonstration projects intended to support the regulatory policy roadmap in collaboration with cross-functional internal teams comprised of different disciplines including but not limited to Product Management, Operations, Oncology, Quantitative Sciences, Marketing, and Engineering teams
- Scope, execute, and deliver end-to-end projects, often with final deliverable being a publication (e.g., conference poster, peer-reviewed manuscript)
- Proactively manage timeline, operational, and/or technical issues to ensure timely and robust project delivery
- Track and communicate progress and decisions clearly and regularly to internal and external stakeholders
- Facilitate communication between internal teams and senior external stakeholders at Food and Drug Administration (FDA), National Cancer Institute (NCI), and other regulatory partners for demonstration projects
- Enhance ongoing and future program management activities across the regulatory policy roadmap based on project management competencies to ensure continuous improvement
- Work with the Regulatory Policy team to liaise with external policy stakeholders including but not limited to government agencies, industry groups, patient advocates, scientific thought leaders, academia, and life science partners
- Work with the Regulatory Policy team to define, implement, and enhance the regulatory policy roadmap
- Work with the Regulatory Policy team to research, draft, review, and disseminate materials to support the regulatory policy roadmap (e.g., white papers, comments for proposed regulations)
- Work with the Regulatory Policy team to ensure successful participation in relevant regulatory-focused conferences and workshops (e.g., slide creation, speaker prep, attendee management, transmission of learnings post-event)
Requirements:
- Direct experience managing complex projects that are scientific, technical, analytical, and/or regulatory in nature. Looking for at least 6 years of direct program management experience
- Ability to work within cross-functional teams and manage multiple simultaneous projects
- Direct experience within a highly regulated environment such as healthcare (e.g., hospital, health insurance company, government agency, life science company)
- Familiarity with one or more of the following United States (US) regulatory frameworks: FDA, Health & Human Services (HHS), Office of National Coordination of Health IT (ONC), Centers for Medicare and Medicaid Services (CMS)
- Experience with analytical and quantitative problem solving
- Structured communication skills (both oral and written) at all levels and across various disciplines
- Passionate about our mission to improve lives by learning from the experience of every cancer patient
- Ability to travel to Washington, DC (approximately 1-2 times per month)
- Bachelor’s degree or equivalent experience
Bonus Points:
- Direct experience working with domestic government health agencies such as FDA, HHS, NCI, or comparable international health agencies such as European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.
- Familiarity with the regulatory affairs or regulatory policy (primarily FDA)
- Health policy knowledge
- Background as government affairs or policy professional in health sector
- Experience interpreting and translating complex regulatory requirements
- Experience in clinical research, epidemiological, or outcomes research (real-world evidence)
- Oncology experience
- Clinical experience (e.g., nursing or pharmacy)
- Experience working with oncologists/clinicians
- Direct experience with scientific and/or regulatory writing
- Advanced degree: MBA, MPH, MS, PhD
