Associate Director, Clinical Operations

Role Summary

Associate Director, Clinical Operations responsible for independently leading global and complex clinical trials. Lead the Study Management Team, oversee clinical vendors and CROs, and ensure successful execution and conduct of clinical trials. Directly manage a large, complex early-phase oncology study, including vendor selection, protocol and study document development, feasibility and start-up, maintenance, and closure. Provide leadership within Clinical Operations, participate in SOP development, and manage direct reports with cross-functional stakeholder management. Location: San Francisco headquarters with an expectation of at least 3 days per week in office.

Responsibilities

• Provide strategic input and leadership in study setup and execution of highly complex oncology clinical trials. May support multiple trials
• Establish and continuously monitor study timelines and budgets, promptly escalating significant risks or changes, as appropriate
• Develop and manage study contracts, budgets and timelines
• Author/review core study documents including protocol and Informed Consent Forms
• Manage CRO, central lab, systems vendors, and ancillary vendors to ensure on target deliverables
• Develop study plans and relevant study document templates for study teams
• Able to support regulatory strategy and assess trial/program impact and RFIs from multiple countries
• May lead RFP process, budget development, and study forecast/planning including timelines
• May perform sponsor oversight site visits
• Manages oversight of clinical monitoring activities including monitoring trip report review and the overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics
• Reviews monitoring trip reports and track resolution of all action items
• Manage team with direct reports within therapeutic area
• Clinical Operations lead on cross functional project teams and alliance teams
• Stakeholder management with internal business partners, key opinion leaders, and external partners on clinical studies

Qualifications

• Bachelor of Science degree is required, preferably in the life sciences
• 10+ years of clinical development experience in the biotech/pharmaceutical industry
• Extensive experience working on oncology clinical studies
• Experience in managing and leading clinical studies both in early phase through late stage of development
• Experience in leading all stages of clinical trials including start up, maintenance and closeout
• Thorough understanding of FDA, EMEA, and ROW ICH and GCP guidelines, as well as thorough understanding of cross-functional clinical processes including and not limited to data management, biostatistics, medical monitoring, drug safety, regulatory affairs
• Experience with regulatory compliance audits and inspections
• Experience directing and leading in a complex team environment
• Ability to function at a high level when leading a group or managing staff, but ability to manage day-to-day details when needed
• Flexibility to travel domestically and internationally

Education

• Bachelor of Science degree is required, preferably in the life sciences