Senior Director, Regulatory Affairs, PMA (Menlo Park or Remote) #2323

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.

The Senior Director Regulatory Affairs will lead the development of regulatory strategy and submissions for multi cancer early detection (MCED) PMA product registration, supplements, amendments, IDEs and/or periodic experience reports etc. Provides strategic regulatory direction to teams and negotiates with regulatory agencies to expedite approval of product registrations. Monitors and communicates regulatory strategy and changes in regulatory requirements to project teams and leadership. Manages, leads and provides direction to Regulatory Staff and when required participates in GRAIL Senior Management meetings. Develops and drives a work culture committed to GRAIL values - Grit, Respect, Accountability, Integrity and Leadership.
You will:

• Strategize, scope and plan regulatory activities to best position GRAIL’s products with FDA and/or health authorities
• Lead and guide IVD submission teams on strategies to realize cross-functional efficiencies throughout the organization.
• Directly responsible for authoring and providing critical input on FDA/Health Authority submissions for GRAIL MCED products including PMA modules, IDEs, annual reports/supplements, Study Risk Determinations and pre-submissions etc. May also support GRAIL Laboratory Developed Tests (LDTS) as needed.
• Lead regulatory contact for FDA, Health Authority negotiations on GRAIL MCED products.
• Provide project portfolio headcount and budgeting approximations to the Project Team; attend project team meetings, as needed, to assign resources and provide regulatory input.
• Serve as a key member of the Regulatory team providing insights, solutions and direction on general business and product portfolio matters.
• Provide regulatory support towards new and currently marketed products including both IVDs and Lab Developed Tests, e.g., labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval
• Review, interpret, and report to Regulatory and Business leadership on product specific regulatory issues that may have material impact on the business or the customer.
• Work with Regulatory Affairs leadership to develop strategic and tactical responses to influence a reasonable regulatory environment.
• Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and subject area as relevant to assigned projects.
• Lead the identification of regulatory risk areas and develop alternative courses of action.
• Assess impact of new regulations and work with cross-functional partners to implement appropriate changes.
• Represent GRAIL during communication and meeting with FDA, Health Authorities and work with regulatory authorities on regulatory and technical matters, as appropriate.
• Support the Compliance Team with respect to healthcare laws relevant to medical devices and laboratory operations (e.g., CLIA, HIPAA).
• Ensure compliance with regulations and laws pertaining to the GRAIL business and provide guidance and advice.
• Independently review and approve Regulatory Strategy Documents, Regulatory Plans, procedures, SOPs and other documentation with respect to commitments, regulations and filings
• Support the development and review of Standard Operating Procedures and policy guidelines for the regulatory affairs department.
• Provide consultative and training support to the business teams and core regulatory personnel related to premarket submissions, product labeling, and complex submissions issues
• Responsible for managing direct reports which includes, but is not limited to, hiring/firing decisions, selection, performance feedback, pay decisions, and handling employee’s grievances/complaints.
• Perform other duties as required or assigned

Your qualifications and background will include:

• B.S./B.A. in a science or related life science field; M.S or Ph.D. in the field of biology, microbiology or relevant disciple preferred.
• Regulatory Affairs Certification preferred.
• Minimum of 12 years’ experience in regulatory, R&D, clinical affairs, quality in IVD, medical device, or pharma industries. Regulatory affairs experience is preferred. IVD device experience is preferred. Advanced degree may count toward years of experience.
• Experience with regulatory submissions for PMA, IDE and CE Mark
• Experience in diagnostics or biomarker development with emphasis on oncology a plus
• Pharma clinical/statistical/regulatory experience in oncology, immunology or related field a plus
• Experience with Microsoft based applications and general knowledge of PC functions necessary.
• Track record of leadership, providing sound regulatory judgment/ideas
• Demonstrated knowledge of regulations and procedures required for development of new IVDs, medical devices, submission of applications to the FDA, EU and rest of world health authorities for approval to market new IVDs, medical devices.
• Demonstrated ability to effectively present information to senior management and to regulatory agencies with experience in the design and development of formal meetings and presentations to FDA for IDE, PMA, NDA/BLA level agency interactions, including pre-submission meetings and advisory committees.
• Strong interpersonal/integrating/problem-solving skills and demonstrated ability to collaborate effectively across a variety of workgroups in demanding/changing situations
• Ability to interpret and respond to requests from regulatory agencies.
• Ability to work in a fast-paced/entrepreneurial team environment.
• Excellent oral and written communication skills.
• Strong organizational skills and attention to detail required.
• Ability to work in a cross-functional team structure.
• Ability to drive and manage change with a positive approach.
• Committed, focused, likes to have fun.

GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Following extensive monitoring, consideration of business implications, and advice from internal and external experts, GRAIL US has made the decision to require that all U.S. employees be “Fully Vaccinated” with the COVID-19 vaccine and “Up to Date” with any recommended booster. “Fully Vaccinated” is defined as two weeks after both doses of a two-dose vaccine (e.g. Pfizer or Moderna) or two weeks since a single-dose vaccine (e.g. Johnson & Johnson) has been administered; "Up to Date" means having timely received any COVID-19 vaccine booster(s) in accordance with CDC guidelines. Absent a qualifying exemption, all GRAIL US employees are to comply with this requirement, including providing documentation of such vaccination status, as a condition of employment. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation for consideration by GRAIL.