Sr Director Medical Evaluation Grade 33

Sr Director Medical Evaluation Grade 33
United States - New Jersey - Morris Plains

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


Key Responsibilities:
Provides medical strategy and input into key regulatory decisions pertaining to safety of multiple products , including representing safety 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 for assigned molecule or therapeutic area including surveillance
programs, aggregate review and risk management planning
Collaborates with drug safety's risk management team in proactive identification and assessment of safety signals and trends, and supports management of any potential safety issues
Executes process change and initiatives based on deep understanding of GVP and other regulatory guidance
Participates in SOP updates, audits, data analysis and other ad hoc activities
Communicates to highest levels of senior management key pharmacovigilance findings
Provides global medical leadership for product focused safety activities
Provides global strategic input to organization to mitigate pharmacovigilance-related risk

Minimum Qualifications:
MD Degree or equivalent; board certification
8+ years of drug safety/pharmaceutical industry or clinical practice experience with extensive PV expertise in one or more therapeutic area
Significant knowledge of EU and FDA PV guidelines, GCP and clinical research methodology
Extensive and demonstrated leadership including problem solving, negotiation, organization and planning skills
Demonstrated effective written and verbal communication skills
Proficiency with MS Word, Excel, and PowerPoint
Proven scientific/clinical and analytical knowledge base with ability to assess data and understand the safety/medical implications
Solid understanding of pharmacoepidemiology and ability to provide sound critique of observational studies

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.

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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YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

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:
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