We're looking for a Senior Director of Global Regulatory Policy to help us accomplish our mission to improve lives by learning from the experience of every cancer patient. Here's what you need to know about the role, our team and why Flatiron Health is the right next step in your career.
This role is a unique opportunity to shape policies that will help advance the use of real-world evidence for oncology medical product development and regulatory decision making through work with internal and external experts including life science partners, regulators, policy makers and other thought leaders. In this role, you will provide regulatory policy intelligence and knowledge to internal teams, drive the company’s advocacy agenda, including through alliances, and manage key external relationships to advance regulatory policies. A deep understanding of both medical product laws and regulations and the policy making process are critical for this role. This role reports to our VP of Regulatory Affairs.
What You'll Do
You will help lead, develop and implement Flatiron’s regulatory policy advocacy strategy. In addition, you will:
- Work collaboratively with internal and external stakeholders to influence the regulatory policy environment and advance FDA, EMA and PMDA guidelines for the use of real-world evidence
- Evaluate and disseminate the latest regulatory policy intelligence to internal stakeholders and contextualize the impact on the Flatiron Health business
- Serve as a liaison for regulatory policy-focused projects and cross-functional initiatives
- Develop a stakeholder strategy and manage relationships with patient advocates, academics, and others
- Collaborate closely with life science partners and allied organizations on joint advocacy
- 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.
- Help develop Flatiron Health regulatory policy positions in collaboration with internal stakeholders and draft public comments in response to regulations and guidance issued by regulators and health authorities
- Gather regulatory policy intelligence, analyze changes in the regulatory environment, and work closely with internal subject matter experts to assess the impact of regulatory policies on the Flatiron Health’s business goals
- Propose and respond to draft legislation, regulations, guidelines and policies related to the use of real-world evidence
- Manage select meetings with FDA and other health authorities as assigned
- Provide insights and advocate for positions on critical regulatory trends in support of a broader policy platform; and
- Build influence through engagement in relevant trade associations, coalitions and alliances
Who You Are
You're a regulatory policy expert and leader with at least 5 years of federal policy experience within a relevant organization. (e.g. life sciences industry, leading policy think tank, or regulatory agency such as FDA). You're excited by the prospect of rolling up your sleeves to tackle meaningful problems each and every day, with a forward-looking mentality as it relates to regulatory policy strategies. You're a kind, passionate and collaborative problem solver who seeks and gives candid feedback, and values the chance to make an important impact.
- You have a solid track record of regulatory policy achievements within biopharma, a real-world data organization or a similar industry and ideally, an advanced scientific or medical degree (e.g. MS, PharmD, PhD, MD, NP)
- You have solid knowledge of laws, regulations and guidance related to medical product development and approval, preferably with both the US FDA and EMA
- You have fluent knowledge of drug development; experience with real-world evidence, oncology. An understanding of regulations pertaining to medical software and digital health highly desirable
- You have experience synthesizing input from cross-functional teams
- You have strong organizational, interpersonal and networking skills
- You have outstanding communication skills (written and verbal, both formal and informal)
- You have the ability to manage multiple projects simultaneously in a fast paced environment
- You are effective at driving collaboration, achieving results, influencing, and resolving conflicts across internal and external stakeholders
If this sounds like you, you'll fit right in at Flatiron.
- You have a deep knowledge of regulatory policy related to the use of real-world evidence for regulatory-decision making
- You have experience in policies related to personalized medicine and a understanding of the current oncology product landscape
- You have experience with medical device regulations, including software as a medical device
- You have a working knowledge or expertise in policies related to the use of AI and machine learning
- You have worked for a medical product regulatory or health authority
Why You Should Join Our Team
A career at Flatiron is a chance to work with everyone involved in the future of cancer care and research—all under one roof. Researchers, data scientists, designers, clinicians, technologists and many more all work together to improve cancer care and accelerate research.
At Flatiron, we strive to build and maintain an environment where employees from all backgrounds are valued, respected and have the opportunity to succeed. You'll also find a culture of continuous learning, broad and inclusive employee support offerings, and a commitment to supporting our team members in all aspects of their lives—at home, at work and everywhere in between. We offer:
- Flatiron University training curriculum which includes presentation skills, meeting mastery, coding languages and more
- Career coaching opportunities
- Hackathons for all employees (not just our engineers!)
- Professional development benefit for attending conferences, industry events and external courses
- Work/life autonomy via flexible work hours and flexible paid time off
- Generous parental leave (16 weeks for either parent)
- Back-up child care
- Flatiron-sponsored fitness classes
Flatiron Health is proud to be an Equal Employment Opportunity employer.
We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics