Executive Medical Director, Pharmacovigilance Risk Management (PVRM)

Exelixis; Alameda (CA); On-site; USD 250,000 - 350,000; Full time

Job summary

Exelixis is seeking an Executive Medical Director, PVRM to lead the global product safety strategy for complex oncology programs and post-marketing pharmacovigilance activities. You will mentor the safety team, drive proactive safety surveillance, and partner with cross-functional groups to plan and manage risk management and safety deliverables across development and lifecycle.

The role involves presenting safety data to Health Authorities and risk committees, developing core safety documents,

Qualifications

• MD degree and 10+ years of post-residency experience, or equivalent.
• Experience in pharmacovigilance in a pharma/biotech company.
• Leadership and management experience preferred.
• Pharmacovigilance experience in Oncology is a plus.

Responsibilities

• Lead safety strategy for complex oncology programs.
• Create data analysis strategies across clinical studies.
• Perform safety data interpretation on analyses.
• Set strategy for safety deliverables (signals, reports, risk management).
• Lead cross-functional Benefit Risk Team and escalate to BR Executive Committee.
• Develop core safety documents detailing product safety profile.
• Lead proactive safety data reviews and anticipate concerns.
• Oversee safety data evaluations in global aggregate reports.
• Present safety data to Health Authorities and boards.
• Develop risk management strategies and monitoring plans.
• Co-lead benefit-risk assessment with other functions.

Skills

Leadership

Cross-functional collaboration

Communication skills

Pharmacovigilance knowledge

Strategic thinking

Education

MD degree

10+ years post-residency

Job description

SUMMARY/JOB PURPOSE:

The Executive Medical Director, PVRM is responsible for the development and execution of the global product safety strategy for complex clinical development program(s) as well as post-marketing pharmacovigilance activities for Exelixis products. This role leads and mentors team members to proactively and successfully plan and manage key safety surveillance activities, safety analyses, risk management and safety document deliverables. This role also engages and collaborates cross-functionally to execute on the corporate development strategy.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The incumbent operates in a matrix environment within the global patient safety function and the broader development organization. Responsibilities for this position include:

• Lead and develop the safety strategy for complex clinical development programs for oncology products in development or products with a marketing authorization.
• Create appropriate safety data analysis strategies across clinical studies for a product.
• Perform appropriate data interpretation on the performed safety analyses for a product.
• Set a clear strategy for key safety deliverables for the product (e.g., safety signals, aggregate reports, risk management planning, safety data pooling, regulatory filing documents, clinical development documents).
• Lead the cross-functional Benefit Risk Team for the assigned product and **escalate** important safety updates to the Benefit Risk Executive Committee in a timely fashion.
• Lead the development of core safety documents, which characterize the safety profile of the product appropriately.
• Lead proactive safety data reviews and anticipate safety concerns for the assigned product.
• Oversee the development of safety data evaluations and summaries in the global periodic safety aggregate reports for the product.
• Present safety data and provide safety expertise on the product 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 product.
• Co-lead the benefit-risk assessment for the product with other functions.

SUPERVISORY RESPONSIBILITIES:

• Has supervisory responsibilities over direct reports
• Significant cross-functional and cross-departmental interactions with clinical development, biometrics, medical affairs and regulatory affairs.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• M.D. degree and a minimum of 10 years of post-residency experience; or,
• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• 3+ years of clinical experience post-residency
• Board Certification (if US) preferred
• At least 10 years of experience of pharmacovigilance experience or other relevant experience (e.g., Clinical Research) in a pharmaceutical/biotechnology company.
• Significant clinical experience may compensate for shorter experience in pharmaceutical/biotech company
• Pharmacovigilance experience in Oncology is a plus.
• Prior project and team leadership/management experience is preferred.
• 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 throughout the entire product lifecycle
• Extensive knowledge of US and international pharmacovigilance regulations, with experience in their practical application throughout the entire product lifecycle
• Demonstrates advanced skill and keen insight in gathering, analyzing and applying key information to solve complex 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. Selects communication method and medium appropriate to the message and the audience. Speaks clearly and confidently in one-to-one situations and effectively presents to large audiences within and outside Exelixis.
• Strong interpersonal skills and ability to incorporate differing views to resolve challenges and develop agreed upon resolutions
• 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.

JOB COMPLEXITY:

• Capable of strategically and 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 and promote efficiency
• Designs and implements solutions to address cross functional challenges, taking into consideration the broader impact

WORKING CONDITIONS:

Exelixis is an Equal Opportunity Employer. We are committed to fostering an inclusive environment where everyone can thrive. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy (including lactation, childbirth, or related medical conditions), sexual orientation, gender identity, age (40 and over), national origin or ancestry, citizenship or immigration status, physical or mental disability, genetic information (including testing and characteristics), veteran status, uniformed servicemember status, or any other characteristic protected by applicable federal, state, or local law. We are also committed to providing reasonable accommodations to qualified individuals with disabilities, unless undue hardship and/or a direct threat to the health and/or safety of the individual or others would result.

If you have a disability and need an accommodation in relation to the recruiting process, please email us at: [e-mail].

Exelixis is an E-Verify employer.

WORKING CONDITIONS:

Our office is a modern space that fosters collaboration 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.

DISCLAIMER:
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.