Regulatory Affairs Sr. Director, Companion Diagnostics

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. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com.

The Regulatory Affairs Senior Director, collaborates with internal development teams and pharmaceutical partners to develop global (FDA, EU and rest of world) regulatory strategies for GRAIL Companion Diagnostics (CDx) products. Leads project teams in the development of CDx submissions for product registrations, supplements, amendments, and/or periodic experience reports etc. Provides strategic regulatory direction to teams and negotiates with regulatory agencies to expedite approval of CDx product registrations. Monitors and communicates regulatory strategy and changes in regulatory requirements to project teams and leadership. May manage, lead and provide direction to Regulatory Staff and when required participate in Senior Management meetings as a delegate. Develops and drives a work culture committed to GRAIL values - Grit, Respect, Accountability, Integrity and Leadership.

As part of your responsibilities, you will:

• Strategize, scope and plan activities to best position GRAIL's CDx products with pharma partners, FDA and/or health authorities
• Lead and guide CDx 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 CDx including PMA modules, IDEs, annual reports/supplements, IND amendments, Study Risk Determinations and pre-submissions etc.
• Lead regulatory contact for FDA, Health Authority negotiations on GRAIL CDx products.
• Primary interface with Pharma partners; educate internally and externally to provide continuous improvement and alignment.
• Assist the CDx business team during evaluation by potential pharma partners and contribute to strategic partnerships
• Interact with new potential pharma partners to secure business opportunities; educate and guide on initial standard methodologies and strategies.
• 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, e.g., labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to US and international regulatory requirements.
• Review, interpret, and efficiently report to Regulatory and Business leadership on product specific regulatory issues that may have material impact on the business or the customer.
• Acquire and maintains current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and field as relevant to assigned projects.
• Lead the identification of regulatory risk areas and develop alternative courses of action.
• Represent GRAIL during communication and meeting with FDA, Health Authorities and work with regulatory authorities on regulatory and technical matters, as appropriate.
• Ensure compliance with regulations and laws pertaining to the GRAIL business and provide mentorship and advice.
• Independently review and approve Regulatory Strategy Documents, Regulatory Plans, procedures, SOPs and other documentation with respect to commitments, regulations and filings
• Build the development and review of Standard Operating Procedures and policy guidelines for the regulatory affairs department.
• Provide consultative and training support to business teams and core regulatory personnel related to premarket submissions, product labeling, and complex submissions issues
• If required, may be responsible for managing indirect and direct reports
• Work on other duties as required or assigned

Your qualifications will include:

• B.S./B.A. in a science or related life science field; advanced degree preferred.
• Regulatory Affairs Certification preferred.
• Minimum of 12 years' experience in regulatory, development, clinical affairs, quality, or program management in IVD, medical device, or pharma industries.
• Regulatory affairs and IVD device experience is preferred.
• Experience with Companion Diagnostics (CDx) regulatory submissions for IDE, PMA and CE Mark
• Pharma clinical/statistical/regulatory experience in oncology, immunology or related field a plus.
• Track record of leadership, providing sound regulatory judgment/ideas on Companion Diagnostics
• Demonstrated knowledge of regulations and procedures required for development of new medical devices, submission of applications to the FDA, EU and rest of world health authorities for approval to market medical devices.
• Proven 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

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

GRAIL, Inc. and its affiliates and subsidiaries ("GRAIL") does not accept any liability for fees for resumes from recruiters or employment agencies ("Agency"), without a binding, written recruitment agreement between GRAIL and Agency describing the services and specific job openings ("Agreement"). GRAIL may consider any candidate for whom an Agency has submitted an unsolicited resume and explicitly reserves the right to hire those candidate(s) without any financial obligation to the Agency, unless an Agreement is in place. Any email or verbal contacts with any person within GRAIL is inadequate to create a binding agreement. Agencies without an Agreement are requested not to contact any hiring managers of GRAIL with recruiting inquiries or resumes. Agencies interested in partnering with GRAIL may contact GRAIL's HR Department through our Customer Service team .