Director, Medical Evaluation (ME), Global Patient Safety

Location
Foster City, CA
Posted
Nov 26, 2021
Ref
2667497
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Director, Medical Evaluation (ME), Global Patient Safety
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

  • Collaborates with Safety Scientists in the identification and assessment of safety signals and trends; presentation of medical safety review to product safety committees and senior management, and supports management of any potential safety issues; provides medical review of aggregate reports such as periodic safety update report (PSURs) and other periodic safety reports
  • Contributes to preparation and review of safety documents in response to regulatory inquiries
  • Participates in audits, data analysis, and other ad hoc activities
  • Participates in both internal and external educational initiatives
  • Contributes to, and may manage, a critical component of a functional or cross-functional project
  • May lead and initiate functional area projects
  • Participates in process improvement initiatives by identifying areas for improvement and presents solutions
  • May serve as medical monitor for post-authorization safety studies
  • May serve on higher level intradepartmental and interdepartmental cross-functional projects and /or clinical sub-teams when appropriate
  • Participates in standard operating procedure (SOP) updates
  • Establishes recognition as an expert on medical safety assessment of individual cases

Essential Duties and Job Functions
  • Provides medical safety review and/or sign off for wide variety of safety documents, both within GLPS and cross functionally, including clinical study protocols, investigator brochures (IB), clinical study reports (CSRs), reference safety information (RSI), regulatory documents, and other documents for investigational and marketed products
  • Performs continuous risk/benefit evaluation throughout the lifecycle of various assigned innovative products

Knowledge, Experience and Skills
  • Requires an MD/DO degree or equivalent
  • Requires completion of an accredited medical or surgical residency program. Board certification is preferred.
  • Should have an exceptional track record of excellence in clinical practice in a medical specialty
  • Should have an excellent scientific/clinical and analytical knowledge base, with ability to assess data and understand the safety/medical implications
  • Ability to communicate to high level stakeholders under tight deadlines and to manage multiple major projects simultaneously
  • Beneficial to have an exceptional track record of excellence in an area including clinical research, health administration, health policy, or epidemiology. Beneficial to have experience in a pharmacovigilance or applicable role in the pharmaceutical industry with a general understanding of relevant regulatory requirements.



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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.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

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

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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.

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