Senior Director, Medical Evaluation (Pharmacovigilance - MD)

Location
Foster City, CA
Posted
Jul 29, 2021
Ref
2399397
Required Education
Doctorate/PHD/MD
Position Type
Full time
Senior Director, Medical Evaluation (Pharmacovigilance - MD)
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

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Specific Responsibilities:
  • Serves as a senior scientific and clinical expert for safety profile of products in therapeutic areas
  • Defines global product safety strategy and routinely manages and leads functional and cross-functional projects
  • Works under consultative direction towards long-term GLPS goals and objectives; assignments are self-initiated with almost no direct supervision
  • Serves on senior-level cross-functional teams
  • Communicates to highest levels of senior management key pharmacovigilance findings
  • Provides global medical leadership for product-focused safety activities
  • Provides global strategic input to the organization to mitigate pharmacovigilance-related risk
  • Executes process changes and initiatives based on deep understanding of good pharmacovigilance practices (GVP) and other regulatory guidance
  • Participates in standard operating procedure (SOP) updates, audits, data analysis, and other ad hoc activities
  • Collaborates with Medical Safety Science - Risk Management (MSS-RM) in proactive identification and assessment of safety signals and trends, and supports management of any potential safety issues
    Essential Duties and Job Functions
  • Oversees clinical development and medical safety support for all project related activities for multiple products
  • Provides medical strategy and input into key regulatory decisions pertaining to the safety of multiple products, including representing the GLPS Department at advisory panels and meetings with regulators or other internal and external stakeholders
  • Establishes the direction for pharmacovigilance activities for assigned products and provides global medical leadership and input into all aspects of safety of assigned molecule or therapeutic areas including surveillance programs, aggregate review and risk management planning

    Knowledge, Experience and Skills
  • Requires an MD/DO degree or equivalent
  • Completion of an accredited medical or surgical residency program is required. Board certification is preferred
  • Should have both: (1) a minimum of 4 years experience in a pharmacovigilance or applicable role in the pharmaceutical industry with significant knowledge of relevant regulatory requirements AND (2) a substantial knowledge of drug safety including previous experience in a leadership role in the pharmaceutical industry
  • Possesses solid understanding of pharmacoepidemiology and ability to provide a sound critique of observational studies
  • Demonstrates an excellent scientific/clinical and analytical knowledge base, with ability to assess data and understand the safety/medical implications
  • Possesses significant knowledge of EU and FDA pharmacovigilance guidelines, good clinical practice (GCP), and clinical research methodology
  • Establishes recognition as a clinical and scientific expert on project and cross-functional teams and “end-line” decision maker for product safety decisions on behalf of GLPS
  • Demonstrates ability to independently lead crisis management scenarios
  • Demonstrates ability to self-initiate pharmacovigilance processes

    For jobs in the United States:

    As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans\' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

    For more information about equal employment opportunity protections, please view the ‘EEO is the Law' poster.

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    PAY TRANSPARENCY NONDISCRIMINATION PROVISION

    Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

    Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

    For Current Gilead Employees and Contractors:

    Please log onto your Internal Career Site to apply for this job.
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