Group Head of Clinical Operations

Who We Are

23andMe, the leading consumer genetics and research company, has accumulated a wealth of genotypic and phenotypic information from participants committed to improving human health through advances in genomics. Our Therapeutics team in South San Francisco leverages this data to discover and develop new treatments that can offer significant benefits for patients with serious, unmet medical needs.

This dedicated research and drug development group identifies novel targets using 23andMe's genetic database and performs preclinical research to advance programs towards clinical development. We currently have programs across several therapeutic areas, including but not limited to oncology, respiratory, and cardiovascular diseases. More information about our Therapeutics team is available at https://therapeutics.23andme.com/.

We are seeking a Group Head of Clinical Operations to lead and manage the Therapeutics Clinical Operations team and have a key role in setting and executing Function strategy, including developing and overseeing the creation and execution of clinical development strategies and policies, budget planning, project delivery and people development. In this role you will be responsible for putting procedures in place to support participant safety, protocol compliance, data quality, efficient study completion, data sharing, and timely publication and dissemination of results.

What You'll Do

• Plan and lead end-to-end clinical operational activities to ensure efficient and high-quality clinical trial execution; accountable for related corporate and departmental goals
• Contribute to the development of and oversee execution of clinical development strategies including budget planning and project delivery timelines
• Oversee operational activities to ensure internal/external guidelines and regulatory compliance, including the development, maintenance and revision of relevant SOPs
• Develop and maintain strong collaborations with key internal and external stakeholders
• Work in a “hands-on” small team environment to successfully drive results, including taking on a “roll-up-the-sleeves” approach to critical activities
• Provide strategic and tactical insights on clinical operational aspects to the clinical development plans for Therapeutics
• Identify and ensure resolution of project and trial level issues
• Maintain up–to–date knowledge on clinical trial methodology and trends
• Manage study timelines, budgets, and vendor performance to meet departmental and corporate goals
• Identify risks to study timelines and propose mitigations and implement solutions with team and management support
• Prepare project and study-related documents, including feasibility questionnaires, informed consent forms, trial dashboards
• Manage clinical trial vendors, monitor, track clinical trial progress, and provide status reports; ensure compliance with protocol, overall clinical objectives, and regulatory requirements, and participate in vendor governance meetings, as needed
• Oversee the selection of investigators and study sites, selection of clinical vendors, and monitor oversight of CRAs and regional sites for adherence to protocol and GCP
• Review monitoring trip reports and provide guidance on site issues; identify and respond to site and study-related issues and recommending corrective actions
• Participate in Qualification Visits, Site Initiation Visits and Close Out Visits as required
• Prepare or review clinical sections of regulatory submission documents, responses to EC and/or Health Authority questions
• Work closely with remote CMC and Preclinical teams to oversee vendor activities; overall IMP accountability, reconciliation; PK/PD sample management; review of DTAs and study plans/manuals
• Travel – Domestic and International, approximately 10-15%
  

What You’ll Bring

• Minimum BA/BS in a scientific discipline with at least 8 years of relevant clinical experience with industry-led clinical trials, with significant experience of successful execution of global phase 1-3 clinical trials at the CTM or higher level and experience with leading clinical programs across multiple clinical trials.
• Knowledge of ICH/GCP and FDA regulations; extensive expertise in developing operational strategies and strong knowledge of ICH/GCP guidelines and multinational clinical trial guidelines (including operational, regulatory, quality and legal aspects)
• Experience with all phases in clinical trial conduct, including setup, maintenance and closure
• Demonstrated experience in leading a clinical team in the management and completion of multiple or complex clinical programs and part