Sr. Pharmacovigilance Risk Management Medical Director

SUMMARY/JOB PURPOSE:

The Senior PVRM Medical Director is responsible for global oversight and management of all medical safety aspects for aggregate data on Exelixis product(s) during clinical development and following marketing authorization. The incumbent directs the Exelixis safety strategy and characterization through appropriate signal management, safety analyses and safety data descriptions in appropriate regulatory documents for the assigned product(s). Additionally, this role develops relevant risk management strategies for specified product-related risks. This position collaborates cross-functionally and escalates new safety findings through the corporate safety governance model.

Essential Duties And Responsibilities:

This role operates in a matrix environment within the drug safety function and cross-functionally with other departments. Responsibilities for this position include:

• Lead the safety strategy for all medical activities on aggregate data for assigned marketed and/or investigational Exelixis product(s).

• Lead the cross-functional Benefit Risk Team for the assigned Exelixis product(s) and escalates important safety updates to the Benefit Risk Committee in a timely fashion.

• Develop and maintain the strategy for ongoing signal detection across available data sources to further define the safety profile for assigned Exelixis product(s) during clinical development and in the post-marketing setting.

• Lead the creation and maintenance of the Company Core Safety Information and ensure that risks are appropriately characterized and communicated in product labels for the assigned Exelixis product(s).

• Provide pharmacovigilance and risk management expertise for the assigned Exelixis product(s) to internal and external customers.

• Lead the safety strategy for clinical development documents and regulatory filing documents for the assigned Exelixis product(s).

• Lead responses to safety questions from regulatory authorities, ethics committees, investigators and other external parties for the assigned Exelixis product(s).

• Lead proactive safety data reviews and anticipate safety concerns for the assigned Exelixis product(s).

• Oversee the development of safety data evaluations and summaries in the global periodic safety aggregate reports for the assigned Exelixis product(s).

• Present safety data and provide safety expertise on the assigned Exelixis product(s) during key meetings (e.g. with Health Authorities, Data Safety Monitoring Boards and Investigators).

• Develop risk management strategies and monitoring plans for risk management effectiveness for the assigned Exelixis product(s).

• Co-lead the benefit-risk assessment for the assigned Exelixis product(s) with other functions.

Supervisory Responsibilities:

• None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• M.D. degree required; Board Certification (if US) preferred and a minimum of 8 years of experience post-residency with at least 3+ years of clinical experience post-residency; or,

• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• At least 7 years of pharmacovigilance experience or other relevant experience (eg Clinical Research) in a pharmaceutical/biotechnology company.

• Pharmacovigilance experience in Oncology is a plus.

• Prior experience in a similar role in a global environment is preferred.

• Significant clinical experience (~ 7 years) may compensate for shorter experience in pharmaceutical/biotech company

• Solid knowledge and understanding of US and EU pharmacovigilance regulatory requirements and general regulatory expectations.

Knowledge/Skills:

• 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

• Demonstrates 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