Exelixis · 4 months ago
Senior Director, PV Case & Study Operations
Alameda, CA
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$262K/yr - $373K/yr
12+ years expExelixis is a biotechnology company focused on drug development and patient safety. They are seeking a Senior Director for PV Case & Study Operations to provide leadership and strategic direction for the Global Patient Safety department, overseeing adverse event case management and ensuring compliance with regulations.
BiotechnologyHealth CarePharmaceutical
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
Qualification
Required
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 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
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 and keen insight in gathering, sorting and applying key information to solve problems
Demonstrates 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 accomplishing common functional and departmental goals
Demonstrates high standards of verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one-to-one situations and effectively presents to audiences within and outside Exelixis
Fosters collaboration among team members. Encourages teams to align on common goals. Engages internal and external stakeholders to build relationships
Strong interpersonal skills and skilled at effectively resolving challenges by developing an agreed upon resolution
Develops procedures, tasks, and tools. Trains staff on departmental products, tools, and data sources. Develops and maintains knowledge of cross-functional products, tools, and data sources. Mentors junior team members. Contributes to performance reviews and professional development plans of team members
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 to avoid potential issues
Designs and implements solutions to address cross functional project level challenges, taking into consideration the broader impact
Engages, influences, and collaborates with stakeholders on cross-functional projects
Benefits
401k plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Sales-based incentive plan
Opportunity to purchase company stock
Receive long-term incentives
15 accrued vacation days in their first year
17 paid holidays including a company-wide winter shutdown in December
Up to 10 sick days throughout the calendar year
Company
Exelixis
Exelixis works is focused on discovering, developing and commercializing therapies for the treatment of cancer and other serious diseases.
1001-5000 employees
H1B Sponsorship
Exelixis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (39)
2024 (25)
2023 (25)
2022 (28)
2021 (29)
2020 (15)
Funding
Current Stage
Public CompanyTotal Funding
$514MKey Investors
Deerfield
2015-07-23Post Ipo Equity· $135M
2012-02-16Post Ipo Equity· $65M
2010-06-03Post Ipo Debt· $160M
Leadership Team
Michael Morrissey
President and CEO
Christopher Senner
Executive Vice President and CFO
Recent News
The Motley Fool
2026-01-09
2026-01-08
Company data provided by crunchbase