Senior Director, Clinical Operations (Biotech, Oncology)

SUMMARY/JOB PURPOSE The Senior Director, Clinical Operations (ClinOps) is responsible for the worldwide execution of all oncology Phase I - IV clinical trials across the Exelixis portfolio. ClinOps plays a key role in ensuring all Exelixis clinical trials are performed in accordance with applicable SOPs, company policies, and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Exelixis' oncology products. The Senior Director, Clinical Operations represents ClinOps at the Product Development Team (PDT) as the Clinical Operations Program Lead. The Clinical Operations Program Lead is accountable for developing the operational strategy and delivery plan to execute the scientific strategy for a product(s) and associated studies, working in partnership with clinical / biostats / clinical supplies and the functional subject matter experts to ensure informed asset decision-making from the operational, scientific and data perspectives. This position provides line leadership to Study Delivery Leads and / or Indication Leads from Senior Clinical Trial Manager to Director level to ensure optimal delivery of program clinical studies through the successful execution of the goals and deliverables outlined in the program corporate and project goals. As a Senior Director, oversees large clinical programs and represents Clinical Operations on internal and external strategy teams, including Product Development Teams (PDTs) which entails accountability for the operational strategy and successful execution of all Clinical Development Plans related to your assigned programs, including financial accountability. This position is accountable for resource management across assigned program, including ongoing assessment of resource needs and optimal deployment of resources. Works seamlessly with CRO and vendors, attending governance and oversight meetings, to ensure optimal delivery to plan. Serves as an expert resource by offering input / ideas to solve operational challenges for all clinical studies in the assigned program and providing expertise to PDT, clinical sub team, etc. In addition, this role is an active member of the Clinical Operations leadership team, leading Clinical Operations and/or cross-functional organizational initiatives and strategies that promote change management to accelerate adoption. Typically acts as the business process owner (BPO) and/or serves as a subject matter expert for complex Clinical Operations processes. Demonstrates an innovative mindset by championing new ideas and initiatives and incorporating best practices, external benchmarking, and standardization across Clinical Operations. ESSENTIAL DUTIES/RESPONSIBILITIES Accountable within the Clinical Operations team for the operational delivery plan to execute the scientific strategy for a product and associated studies (phase 1 – 4), working in partnership with functional subject matter experts. Accountable for delivery of a program of studies in Oncology diseases; and be a key point of contact for portfolio leaders (e.g., Product Team Lead and/or Project Physician Leaders, as appropriate). Contribute to the Clinical Development Plan (CDP) and the development of protocols that align to the CDP to ensure operational feasibility and consistency within the program. Lead resourcing discussions on behalf of Clinical Operations, making recommendations on strategy; endorses the vendor(s) for the program and studies in accordance with the Clinical Operations resourcing strategy & principles; and ultimately approve the Clinical Operations FTE plan to support the program. Oversight of quality delivery by leading the Clinical Operations team to ensure excellence in operational planning and implementation; and being the escalation point for the program in Clinical Operations; ensuring inspection readiness at all times and having regular interactions with Study Delivery Leads involved in the program