Director, Regulatory Policy

| Greater NYC Area

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
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Technology we use

  • Engineering
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Location

Flatiron Health has returned to Soho. We're right next to Trader Joe's! Soho is filled with boutiques, fancy chain stores and art galleries.

An Insider's view of Flatiron Health

What’s the vibe like in the office?

The most exciting part of being in my company is solving a real problem at scale through serious collaboration. Oncologists, software engineers, statisticians, business folks, etc. all have to come to the table together, as equals, to figure this one out. And we are doing it.

Amy

Chief medical Officer

What kinds of technical challenges do you and your team face?

An engineer and oncologist work together over several weeks to build an algorithm from a naive prototype to a highly specialized and flexible rule set that can accurately represent the lines of therapy for 95% of patients within a specific disease subset.

Abhishek

Software Engineer

How does the company support your career growth?

As engineering manager, I am invested in the professional development of the people I work with. I train team members by pulling them out of their comfort zones to the uncomfortable territory. At Flatiron, it is one of our values - greatness and comfort rarely co-exist.

Kevin

Software Engineering

What is your vision for the company?

At Flatiron, we believe that learning from the experience of every cancer patient is an imperative — it is the key to accelerating research and continuing to improve the quality of care. Our mission is to serve cancer patients and our customers by dramatically improving treatment and accelerating research.

Zach Weinberg

Co-Founder, President and COO

What's the biggest problem your team is solving?

Instead of studying the cells, I now have the opportunity to write about the patients. I can tell their stories through the research lens and enable them to advance clinical cancer research through their experiences. I certainly never lose sight of the human behind the cell anymore.

Rana

Medical Writer

What are Flatiron Health Perks + Benefits

Flatiron Health Benefits Overview

Flatiron’s holistic employee experience program translates our values into reality. We cater to the well being of our employees both mentally and physically to promote a culture where wellness is at the forefront. By managing weekly mental wellness programs, monthly office wide fun and fitness classes, we give employees the opportunity to directly incorporate a mindful balance into their day to day life.

Health Insurance & Wellness Benefits
Dental Benefits
Vision Benefits
Health Insurance Benefits
Retirement & Stock Options Benefits
401(K)
Company Equity
Child Care & Parental Leave Benefits
Child Care Benefits
Generous Parental Leave
Flexible Work Schedule
Vacation & Time Off Benefits
Paid Volunteer Time
Perks & Discounts
Casual Dress
Commuter Benefits
Company Outings
Free Daily Meals
Daily catered meals
Stocked Kitchen
Endless snacks & beverages
Happy Hours
Professional Development Benefits
Job Training & Conferences
Robust learning & development curriculum. Participate at industry events.

Additional Perks + Benefits

On a monthly basis, we host a Wellness Day that includes massages, manicures, and meditation sessions. We often set up booths for local wellness organizations and fund on site and off site fitness classes. We also host a bi-weekly meditation in the office.

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