Senior Director, Medical Safety # 3501

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, , North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc.

NASDAQ : ILMN). For more information, please visit .The Sr. Director, Medical Safety will lead the development and implementation of a robust Medical Safety Program across GRAIL.

This role will help shape, and implement the safety strategy and safety risk management for all GRAIL products during the product development and post-market surveillance phases.

This leadership role will be within the Quality, Regulatory and Clinical Compliance organization, and will collaborate with Clinical, Medical Affairs and other teams across GRAIL to implement a safety program that assures regulatory compliance, product quality and patient safety

Responsibilities

• Be responsible for the monitoring, signal detection, analysis, interpretation, and documentation of medical safety information including safety events, literature, and other sources
• Ensure timely and appropriate global reporting of clinical and commercial products
• Develop a comprehensive safety strategy and vision that consolidates safety data and signals from across commercial tests, as well as clinical studies.

Participates in strategic decision-making for maintaining and developing a global safety database and reporting

• Support writing, review, and submission of ad hoc reports, narratives, IFU, annual / quarterly reports, CER, PMCF, PSUR, etc.
• Serve as the external face of the GRAIL in interactions with investigators, regulatory authorities, contract research organizations (CRO) and development partners on safety related issues
• Manage Health Hazard Assessments, and provide safety guidance to internal and external teams
• Leads and oversees ongoing safety risk-benefit assessments and provide support to Quality and Regulatory Affairs organizations
• Partner closely and effectively with Clinical, Medical Affairs, Regulatory, Quality, and Laboratory Operations leaders to proactively assess, respond and communicate safety concerns for products throughout the lifecycle.
• Provide oversight, medical expertise, and leadership for end-to-end medical safety strategy.
• Provide input, assess the significance of relevant information, and generate, author, and / or review medical safety reports as required by worldwide regulatory agencies, including Ad hoc reports, Health Hazard Evaluations, Clinical Overviews, and Risk Management Plans.
• Connect with respective colleagues in the Clinical, Medical Affairs, Global Regulatory Affairs, and Quality for the implementation and compliance of post-marketing risk management commitments.
• In collaboration with Clinical and Medical Affairs, ensure the consistency of safety-related processes to assure cohesive and coordinated approaches, utilizing best practices of both clinical and post-marketing safety to implement necessary process improvements and maximize operational efficiencies.
• Provide leadership in regulatory authority interactions regarding safety and risk management, and ensure compliance of safety activities and processes with global legislation and regulatory requirements.
• Develop a robust safety assessment and position for GRAIL. Present and communicate Safety discussions of MCED tests to internal and external stakeholders.

Preferred Qualifications

MD required with a minimum of 15+ years substantial experience in Medical Device, IVD, or Biotech / Pharma Industry experience;

Clinical experience highly preferred.

• Ideal candidate will have a minimum of 5+ years medical / clinical safety and vigilance with knowledge of US FDA, MHRA, European, and other global regulations.
• Knowledge of safety requirements for FDA Medical Device Reporting (MDR) and EU MDR / IVDR
• Strong leadership capabilities; ability to thrive in a global, matrix environment.
• Significant skills and experience in post-marketing safety assessment.
• Demonstrated in-depth knowledge of principles of clinical trial methodology and design, medical monitoring of trials, assessment of risks and benefits, and safety assessment of products both on the market and in development.
• Proven track record in dealing with difficult safety issues, clinical safety data, interactions with domestic and international regulatory departments / agencies, and strong collaborative and networking skills.
• Ability to successfully manage multiple critical issues simultaneously, critically evaluate data from multiple sources (eg, clinical trials, post-marketing environment, literature), and assess the strategic importance of the data.
• Ability to influence, negotiate, and communicate with internal and external customers.

To be successful in this role you should have :

• Excellent verbal and written communication skills, including formal presentation skills.
• Experience presenting to technical and lay groups at public meetings is desirable.
• Knowledge of Good Clinical Practices (GCP), the conduct of clinical trials, and the appropriate contributions to regulatory filings, and risk management plans.
• Collaborate and influence with cross-functional teams without direct oversight
• Required critical thinking
• Self-motivated
• Strong communication and presentation skills

The expected, full-time, annual base pay scale for this position is $270,000 - $360,000Actual base pay will consider skills, experience, and location.

Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan.

We also offer a long-term incentive plan to align company and colleague success over time.In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.