Senior Director, Clinical Operations (Biotech, Oncology)

About the role

At Exelixis, the Senior Director, Clinical Operations is responsible for worldwide execution of oncology Phase I–IV clinical trials across the portfolio. The role helps ensure trials follow applicable SOPs, company policies, and regulatory guidelines and provide timely, high-quality clinical data supporting global registration and commercialization of oncology products.

Responsibilities

• Represent Clinical Operations at Product Development Teams as the Clinical Operations Program Lead.
• Develop the operational strategy and delivery plan to execute product scientific strategy and associated studies, working with clinical, biostats, clinical supplies, and functional subject matter experts.
• Provide line leadership to Study Delivery Leads and/or Indication Leads, from Senior Clinical Trial Manager to Director level, to support delivery of program clinical studies and their goals and deliverables.
• Oversee large clinical programs and represent Clinical Operations on internal and external strategy teams.
• Be accountable for operational strategy, successful execution of Clinical Development Plans for assigned programs, and financial accountability.
• Manage resources across assigned programs, including ongoing assessment of resource needs and optimal deployment.
• Work with CROs and vendors and attend governance and oversight meetings to support delivery to plan.

Key facts

• Responsible for worldwide execution of oncology Phase I–IV clinical trials across the Exelixis portfolio.
• Represents Clinical Operations at Product Development Teams as the Clinical Operations Program Lead.
• Accountable for operational strategy and execution of Clinical Development Plans for assigned programs.