Executive Medical Director, Pharmacovigilance Risk Management (PVRM)

Exelixis; United States; A distancia; USD 399.000 - 504.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401k with company contributions

Medical, dental and vision insurance

Life and disability insurance

Flexible spending accounts

Descripción de la vacante

Exelixis is seeking an Executive Medical Director, PVRM to lead the global product safety strategy for complex clinical programs and post-marketing pharmacovigilance activities. You will mentor teams, manage safety deliverables, and collaborate across the development organization to execute the corporate development strategy.

The role requires MD with 10+ years post-residency or equivalent, extensive pharmacovigilance experience, and strong regulatory knowledge.

Formación

• MD degree with 10+ years post-residency experience, or equivalent.
• 3+ years of clinical experience post-residency.
• 10+ years pharmacovigilance or relevant pharma/biotech experience.
• Board Certification (US) preferred.
• Experience in oncology pharmacovigilance is a plus.
• Leadership/management experience required.
• Strong knowledge of US/EU pharmacovigilance regulations.

Responsabilidades

• Lead safety strategy for complex oncology programs in development or with marketing authorization.
• Develop safety data analysis strategies across clinical studies.
• Interpret safety analyses and communicate findings.
• Set pre-defined safety deliverables and risk management plans.
• Lead cross-functional Benefit Risk Team and report to BREx Committee.
• Develop core safety documents outlining product safety profile.
• Proactively review safety data and anticipate safety concerns.
• Oversee safety data evaluations for global periodic reports.
• Present safety data to Health Authorities, DSMBs, and investigators.
• Co-lead risk management strategies and monitoring plans.

Conocimientos

Strategic safety leadership

Cross-functional collaboration

Pharmacovigilance

Signal detection

Regulatory knowledge

Excellent communication

Team mentorship

Educación

MD degree

Descripción del empleo

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 elevate 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:

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.

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

Location: Remote Range for this position: $399,000 - $504,000 The base pay offered will take into account 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.