Head of Regulatory Projects, Quantitative Science
We are looking for a senior leader with expertise and experience in a quantitative research field to help us accomplish our mission to improve lives by learning from the experience of every cancer patient. Here is what you need to know about the role, our team and why Flatiron Health could be the right next step in your career.
What you’ll do
The regulatory early scoping team steps in very early in the lifecycle of a project to scope the project and collaborate on the regulatory strategy and process. At a macro level, this involves helping the sponsor develop a core strategy on the regulatory, data fitness and analytical aspects of a potential future regulatory submission. We are looking for a senior quantitative scientist leader with experience in regulatory submissions in drug development to provide the technical and strategic leadership, training and collaboration with our customers and regulatory agencies. Furthermore, as a lead, you will work with your Quantitative Sciences team members to answer some of the most important questions in cancer research and drug development using Flatiron’s unique, large real-world dataset. As a leader on this team, you will:
- Have a deeper understanding of the clinical questions of interest and the sponsor’s regulatory strategy
- Be the point of contact and accountable for Assess project feasibility (e.g. patient counts, availability of desired data elements, etc)
- Generate, review and provide recommendations on the analytical strategy
- Collaborate with a wide array of customers and on a variety of regulatory use cases (e.g. label extensions, PMCs, etc)
- You will be expected to have a solid understanding of our data models and RWD-appropriate analytic methods, which may need you to spend some time coding in R. You will also receive the support of a junior QS team member to do more of the hands-on coding needed for the projects
- Collaborate with a team of oncologists, product and operation managers, clinical data experts, regulatory and compliance specialists, and software engineers to discuss QS capacity around resourcing (collaborate with management to provide optimal resourcing for the projects), scoping of new projects, escalation of project issues, ensuring data quality standards, and team’s strategic vision
- Develop and manage relationships with external partners including life science companies, regulatory agencies, academic institutions and health technology assessment bodies to advance the integration of our analytic products through demonstrated value. As needed participate in regulatory meetings (FDA/EMA)
- As a senior QS team member, have a leadership presence at scientific conferences and meetings by making presentations, organizing sessions, and leading discussions that advance the field of Real-World Evidence (RWE) research
- People management: Mentoring and coaching other QS members within the team is considered a must in this role. Formal people management is not a requirement for the QS lead, however, if a candidate is interested and has the skills to manage a small group of individuals that would be a plus
Who You Are
You are an analytical thinker with 5+ years of work experience in an academic or industry setting. You are excited by the prospect of rolling up your sleeves to tackle meaningful problems each and every day. You are a kind, passionate and collaborative problem-solver who seeks and gives candid feedback, and values the chance to make an important impact.
- You hold a Masters or PhD in a quantitative discipline such as biostatistics, epidemiology, applied statistics, health economics, or a related discipline
- You are an experienced statistician from Pharma who has experience with regulatory submissions (e.g FDA and EMA)
- You have experience collaborating with researchers in the life science industry, academia, or government agencies
- You are a natural teacher; you have a passion for mentoring and teaching those of various backgrounds and levels of experience
- You have drug development experience and are able to understand or relate to the sponsor’s research questions and development strategy
- You have the ability to juggle multiple external interactions and deadlines simultaneously and the adaptability to collaborate with individuals at all levels and functions
- You have excellent written and oral communication skills and a deep attention to detail
- You are comfortable with doing some level of hands on work, R coding (approx 20%)
- You are self-motivated, self-directed and proactive
- You can represent the data and analysis strategy, and get in the technical weeds to explain to our customers
- You are willing to travel (approximately 5-10%)
If this sounds like you, you'll fit right in at Flatiron.
- You have oncology experience
- You have healthcare consulting experience
- You have experience working with longitudinal EMR data
- You have experience working with life sciences companies or health-related government agencies (e.g., CDC, NIH, or FDA)
- You have people management experience
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.
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.