Director, Regulatory Affairs
San Francisco, CA, USA | Freenome
Industry:Pharmaceutical / Biotech
Job Description:63 people have viewed this job
Freenome is a high-growth biotech company on a mission since 2014 to create tools that empower everyone to prevent, detect, and treat their disease. To achieve this mission, Freenome is developing next-generation blood tests to detect cancer in its earliest, most treatable stages using our multiomics platform and machine learning techniques. Our first blood test will detect early-stage colorectal cancer and advanced adenomas.
About the Role
As the Director, Regulatory Affairs (RA) at Freenome, you will be responsible for providing regulatory guidance and oversight to Freenome’s product design and development efforts, especially those focused on analytical validation studies. You will provide insight into appropriate analytical validation study designs and statistical analysis techniques for in vitro diagnostics (IVD). You will also lead regulatory submissions submitted to the FDA.
- Partner cross-functionally with Development, Clinical Laboratory, Quality, Scientific Medical Affairs, and Clinical Development to inform regulatory strategy and requirementsin the design and execution of analytical verification and validation studies as well as clinical validation studies
- Collaborate and review development protocols (AV&CV) to assure collection of appropriate data for regulatory submissions and regulatory compliance,including the use of appropriate standards, acceptance criteria, and statistics
- Provide guidance on how regulators may respond to novel aspects of Freenome’s analytical validation studies and help craft appropriate justifications
- Provide RA leadership/mentorship for assay development, validation, patient enrollment, sample analysis activities, and collection and/or review of regulatory documents.
- Provide leadership and oversight into advice-seeking with the FDA, including formal feedback via pre-submissions.
- Coordinate and direct the preparation of complex regulatory submissions (PMAs, 510(k)s) including the development of strategic and operational plans through sound assessments of regulatory pathways and risks, and sound regulatory programs.
- Serve as a regulatory expert for labeling and promotional materials review, experimental designs, and data analysis as they relate to registration and commercialization of IVDs, and research use only products.
Your background, perspective and experience:
- Ph.D., M.D. or Master’s in a scientific field with a minimum of 6years of relevant industry experience; OR a bachelor’s degree in a scientific field and 10+ years of relevant industry experience
- Directly applicable regulatory affairs work experience (e.g., IVD 510(k), PMA, de novo, IVDD and IVDR compliant tech files, etc.) in an IVD medical device company.
- Familiarity with CAP/CLIA (LDT) regulations
- Strong understanding of best practices, CLSI guidelines, ISO standards, and cGxP strategies supporting diagnostic product development and submissions to regulatory agencies
- Solid understanding of biostatistics, analytical validation, programming, and data management
- People leadership experience for teams of 2+ RA staff
- Excellent written and verbal communication
- Ability to manage multiple projects and priorities simultaneously
- Familiarity with genetic testing, NGS, and/or immunoassays desirable
- Proficiency with MS Office and/or Google Suite
As a condition of employment, you agree to know and comply with our COVID-19 vaccination policy requiring all employees who work on-site and/or attend work-related events to be fully vaccinated and to receive a COVID-19 booster once eligible. Company employees working on-site are required to be fully vaccinated for COVID-19 and to receive a COVID-19 booster once eligible, unless a reasonable accommodation is approved or as otherwise required by law. Absent a reasonable accommodation or legal exception, you agree to provide proof of your vaccination status and to be fully vaccinated by your first day on-site, in accordance with our policy.If you are currently eligible for a COVID-19 booster, you also agree to provide proof of having received a booster.If you are not yet eligible for a COVID-19 booster, you must provide proof of receiving a booster within two weeks of becoming eligible.
Freenome is proud to be an equal opportunity employer and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
We have raised more than $1.1B from leading investors including Perceptive Advisors, RA Capital Management, Roche Venture Fund, Kaiser Permanente, Novartis and the American Cancer Society’s BrightEdge Ventures.
A ‘Freenomer’ is a mission-driven employee who is fueled by the opportunity to make a positive impact on patients' lives, who thrives in a culture of respect and cross collaboration, and whose work makes a significant impact on the company and their career.
Freenomers are technical, creative, visionary, grounded, empathetic and passionate. We build teams around divergent expertise, allowing us to solve problems and ascertain opportunities in unique ways. Freenomers are some of the most talented experts in their fields, joining together to advance healthcare, one breakthrough at a time.
Benefits include but are not limited to:
- Competitive compensation
- Pre-IPO equity
- Flexible PTO (exempt) and generous PTO (non-exempt)
- Comprehensive health coverage, including medical, dental, and vision
- Wellness and mental health resources, including Employee Assistance Programs (EAPs), Paid maternity and paternity leave
- 401(k) plan
- $250.00 new hire stipend to enhance your home office experience
- Plus, a variety of other perks, including pre-tax commuter benefits, two paid volunteer days per year, pet insurance, and additional discounts
Notice to agencies:
Our in-house Talent Acquisition Team manages all employment opportunities at Freenome.Agencies and independent recruiters must be approved as a vendor by Freenome’s Talent Acquisition team before submitting candidates to any Freenome employee.
We do not accept unsolicited resumes or biographies from agencies under any circumstances. Any unsolicited resumes sent to Freenome, including those sent to a Freenome email address or directly to Freenome employees, will be considered Freenome property. Freenome will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Freenome will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees.
Please do not contact Freenome employees directly. Compliance with this request will impact our decision to work with you.
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