Senior Director, PV Case & Study Operations

Role Summary

Senior Director, PV Case & Study Operations – This role provides leadership and strategic direction to the Global Patient Safety case and study Operations department for adverse event case management, vendor oversight, safety submission execution and compliance, and cross-functional collaboration to support risk management and pharmacovigilance activities. Operates in a matrix environment within the Global Patient Safety Department and supports GPS Operations processes.

Responsibilities

• Responsible for leading the global ICSR activities to comply with global ICSR regulations.
• Manage and lead the team who prepares, processes, and performs reporting activities of SAE/SUSAR reports for all Exelixis investigational drugs.
• Oversee processes, training and compliance of external case management vendors.
• Ensure submission compliance with business partners, CROs and global regulatory authorities.
• Provide oversight of ICSR regulatory submissions to ensure compliance with global regulations.
• Ensure data reconciliation of the safety and clinical databases for Serious Adverse Events.
• Effectively utilize metrics to assess productivity, opportunities for workflow and quality improvement, and to measure effectiveness of change initiatives.
• Work with VP, Pharmacovigilance and other GPS colleagues to ensure PV compliance and inspection readiness.
• Support data readiness for generation and submission of aggregate reports (e.g., DSUR, PBRER, and IDMC listings).
• Collaborate with other GPS functions to ensure alignment among case management, aggregate reporting, and signal detection activities.
• Collaborate with clinical teams in the preparation of and updates to safety-related study documents (e.g., Protocols, ICFs, Safety Management Plans).
• Collaborate with the Quality Management function to develop or update Standard Operating Procedures and Work Instructions for GPS, which are integrated and fully aligned.
• Significant cross-departmental interactions with other Exelixis functions, including Clinical Data Management, Clinical Operations, Clinical Development, and Quality Assurance groups.

Supervisory Responsibilities

• This position has supervisory responsibilities and direct reports.
• Expected interactions with external case processing vendor.

Education

• BS/BA degree in related discipline and a minimum of fifteen years of related experience; or,
• MS/MA degree in related discipline and a minimum of thirteen years of related experience; or,
• PhD, MD, or PharmD in related discipline and a minimum of twelve years of related experience; or,
• Equivalent combination of education and experience.

Experience

• Experience in Drug Safety and Pharmacovigilance including 8+ years of experience in Pharmacovigilance Operations.
• Minimum of 7 years of line management experience overseeing PV staff and/or consultants/CROs.
• Working knowledge of and experience with international regulatory Adverse Event Reporting requirements.
• Proven experience and effectiveness at training and mentoring drug safety staff.

Knowledge, Skills And Abilities

• Extensive knowledge of biotechnology/pharmaceutical sector drivers and practices.
• Demonstrated and excellent knowledge of relevant US and international regulations, guidance and initiatives governing both clinical trial and post-marketing safety environments.
• Demonstrated advanced skill in gathering, sorting and applying key information to solve problems.
• Strong organizational and planning capabilities by managing time, workload, and resources of a function.
• Leads and manages a functional area within a department to execute on team functional objectives that contribute to common goals.
• Strong verbal and written communication; provides timely and appropriate information updates; presents effectively to audiences within and outside Exelixis.
• Fosters collaboration among team members and with internal/external stakeholders to build relationships.
• Strong interpersonal skills and ability to resolve challenges by developing resolutions.
• Develops procedures, tasks, and tools; trains staff on departmental products, tools, and data sources; mentors junior team members; contributes to performance reviews and development plans.
• Capable of proactively assessing workload, trends, tasks, and priorities for cross-functional activity.
• Plans and executes multiple projects or activities, considering alternative methods and contingency plans.
• Designs and implements solutions to address cross-functional project challenges with broader impact.
• Engages, influences, and collaborates with stakeholders on cross-functional projects.

Work Environment/Physical Demands

Our office is a modern, open-plan space that fosters collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.