Director, Clinical Study Support

SUMMARY/JOB PURPOSE:

Clinical Operations (ClinOps) is responsible for the worldwide execution of all 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’ products. The Director, Clinical Study Support sits on the Study Optimization leadership team. The role leads a team of Clinical Trial Managers (CTMs), Senior Clinical Trial Specialists (SCTSs), and/or Clinical Trial Specialists (CTSs) who perform tasks and activities in support of studies being delivered on time, at budget, and within ICH-GCP quality framework. The role is responsible for ensuring adequate and knowledgeable resources are in place for optimal delivery of the portfolio of clinical studies as outlined in corporate and project goals. In addition, this role provides input/ideas to solve operational challenges across programs and leads department-specific and/or cross-functional organizational initiatives that promote operational efficiency, effective decision-making, streamline study execution, and enhance cross-functional collaboration. The position may also act as a business process owner (BPO) and/or serve as a subject matter expert for Clinical Operations processes. S/he/they must demonstrate an innovative mindset by championing new ideas and initiatives and incorporating best practices, external benchmarking, and standardization across the department.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Manage and lead a team of CTMs; SCTSs; and CTSs with the structure of the Clinical Operations team.
• Ensure appropriate level of qualified and trained resources to support study delivery and the delivery of Human Subject Research studies within the deadlines, budgets, and quality, according to ICH/GCP, company control documents, and regulatory requirements. 
• Responsible for quality practices, management monitoring, control documents development, and training related to the CTM, SCTS, and CTS roles.
• Responsible for setting and implementing management monitoring of CTM, SCTS, and CTS roles-related processes.
• Accountable for a high level of Quality Control (QC) is embedded in the CTM, SCTS, and CTS day-to-day activities.
• Manage harmonization of proactive at task/activity/process level for CTM, SCTS, and CTS, to ensure consistency, high quality, and efficiency.
• Lead department-wide continuous improvement and capability-building efforts to maximize operational efficiency, effective decision-making, streamline study execution, and enhance cross-functional collaboration.
• Drive the implementation of new practices and best practice sharing.
• Define and analyze resource requirements as per study projections and business needs in collaboration with SDLs, Indication Leads, and/or Clinical Operations Program Leads.
• Support VP of Clinical Operations with budgets associated with CTM, SCTS, and CTS headcount.
• Drive innovative approaches to study delivery through external facing advances in technology and science.

SUPERVISORY RESPONSIBILITIES:

• Recruit, retain, lead, and develop a team of CTMs, SCTSs, and CTSs, supporting study delivery.
• Lead and direct staff by providing key objectives aligned to company vision and strategy, setting clear objectives, expectations, and feedback on performance, and opportunities for development, coaching, and keeping staff motivated during heavy workloads and changing priorities.
• Decide upon appropriate allocation for CTMs, SCTSs, and CTSs to clinical studies to reflect business and development needs in collaboration with SDLs and Clinical Operations Program Leads.
• Establish CTM, SCTS, and CTS performance measurement, track performance, and identify corrective actions.
• Provide leadership, direction, and vision for a team of up to 12 direct reports.
• Contribute to CTM, SCTS, and CTS capability building by supporting onboarding and community forums.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• BS/BA degree in related discipline and a minimum of 13 years of related experience; or,
• MS/MA degree in related discipline and a minimum of 11 years of related experience; or,
• PhD in related discipline and a minimum of 8 years of related experience; or,
• Equivalent combination of education and experience.
• May require certification in assigned area.

Experience/The Ideal for Successful Entry into Job:

• Typically requires a minimum of 5-8