Director, Drug Safety Quality Management

• Provide subject matter expertise and guidance on applicable pharmacovigilance activities
• Track and ensure that CAPAs are appropriate and meet timelines
• Provide leadership of partner and vendor-client meetings
• Actively assist with management of budget for MSAs and SOWs with PV vendors
• Participate in and contribute to PV-related process improvement meetings
• Oversee the collection and review of pharmacovigilance KPIs and compliance metrics related to PV activities.
• Develop the strategy for maintaining regulatory compliance and inspection readiness of the Drug Safety department and its outsourced PV services.
• Partner with QA on Health Authority inspections of the Drug Safety function.
• Oversee the development and maintenance of PV department procedures in alignment with PV regulations and Exelixis requirements.
• Oversee the development or revision of SOPs, work instructions, guidance documents and safety management plans (SMP)
• Manage the development of pharmacovigilance or safety data exchange agreements with business partners and vendors to outline specific obligations for safety data exchange and reporting.
• Oversee the periodic QC of ICSRs and tracking of issues
• Maintain oversight of training of PV Vendors and contracted staff.

• Directly supervise staff

• Equivalent combination of education and experience.
• MS/MA degree in related discipline and eleven years of related experience; or,
• BS/BA degree in related discipline and thirteen years of related experience; or,
• PhD in related discipline and eight years of related experience; or,

• Drug Safety and previous QMS or compliance experience required

• Extensive knowledge of biotechnology/pharmaceutical sector drivers and practices
• Demonstrated and excellent knowledge of relevant international regulations, guidance and initiatives governing both clinical trial and post-marketing safety environments
• Fosters collaboration among team members. Encourages teams to align on common goals. Engages internal and external stakeholders to build relationships.
• Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one-to-one situations and effectively presents information to cross-functional groups of team members and colleagues.
• Demonstrates good organizational and planning skills by managing time, workload and resources of a team
• Demonstrates advanced skill and keen insight in gathering, sorting and applying key information to solve problems
• Good interpersonal skills and demonstrable ability to bring differing views to develop 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.
• Leads and manages a team to execute on team objectives that contribute to accomplishing common functional and departmental goals

• Capable of proactively assessing workload, trends, tasks and priorities for area of responsibility
• Designs and implements solutions to address project level challenges, taking into consideration the broader impact
• Plans and executes multiple activities
• Considers alternative methods and contingency plans to avoid potential issues

Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $216,500 - $307,500 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.