Director, TA Safety Scientists
United States - California - Foster CityUnited 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 #CreatingPossibleFor Current Gilead Employees and Contractors:
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At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
You will develop or oversee and ensure that strategic scientific input relative to safety is incorporated into product development and lifecycle management
as well as perform or oversee activities for one or more products in the assigned therapeutic area.
You will provide strategic input into cross-functional drug development planning and execution across the product lifecycle, from discovery to postmarketing. You will ensure that signal detection, development of benefit-risk evaluation management plans, risk minimization activities, and aggregate safety reports are performed in a timely and quality manner. You will also provide input into study-related activities and documentation, regulatory submissions, responses to regulatory agency inquiries, pharmacovigilance (PV) processes and projects, and PV or other audits and inspections. You may be assigned responsibilities as the Safety Lead (SL); acting as the expert, go-to person regarding the safety profile of a product/compound or group of products/compounds. You will play a lead role by contributing to the ongoing and continuous improvement and advancing capabilities of the function.EXAMPLE RESPONSIBILITIES:
- Accountable for the successful oversight and completion of a broad spectrum of activities and deliverables for one or more products, compounds or indications in the assigned TA, in compliance with established practices, policies and processes, and any regulatory or other requirements.
- Advises other functions on short- and long-range strategies, plans, resources and tactics.
- Performs or otherwise oversees safety reviews of clinical trial protocols, Investigator's Brochures, clinical study reports, informed consent forms, and other study related documents.
- Authors and/or oversees the preparation of aggregate safety reports and risk management plans (RMPs).
- Conducts and/or oversees signal detection and evaluation activities for assigned products as part of the continuous benefit-risk evaluation throughout the product lifecycle.
- Supports implementation of decisions from the signal evaluation process, including updates to core safety information, Investigator's Brochure and other key safety documents and deliverables.
- Contributes to and/or oversees activities and input related to regulatory filings (e.g., Marketing Authorisation Applications [MAAs], New Drug Applications [NDAs], Biologics License Applications [BLAs]), and responses to safety queries from third parties, such as regulatory agencies.
- Participates on Patient Safety (PS) and cross-functional teams, including leadership of special projects, participation in continuous improvement and optimization initiatives, and support in PV audits and inspections.
- Provides matrix management and leadership to project teams.
- May serve as medical monitor for post-authorization safety studies.
- May have one or more direct reports.
- Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
BA/BS or advanced degree in life sciences or related field with extensive experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment, including extensive experience working in drug safety / PV or a related field.Knowledge & Other Requirements
- Expert knowledge of the drug development process, Good Clinical Practices (GCP) and Good Pharmacovigilance (GVP), including worldwide PV regulations and their application to safety science activities (aggregate PV reports, risk management plans, signal detection, clinical trials and clinical development).
- Expert knowledge of all key functions involved in the various stages of drug development from early research through postmarketing.
- In-depth understanding of observational studies used in pharmacoepidemiology and ability to provide sound critique of such studies.
- Strong knowledge of statistical methods used in PV.
- Proven abilities to assume increasing scope and complexity, as evidenced by past successes with team and project leadership, strategic cross-functional partnering, and key contributions to strategy, operational and infrastructure development.
- Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
- Strong interpersonal skills and understanding of team dynamics.
- Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees.
- Strong negotiation and conflict resolution skills.
- Strong coaching capabilities to mentor/develop staff.
- When needed, ability to travel.
The salary range for this position is: $214,795.00 - $277,970.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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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 firstname.lastname@example.org
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For Current Gilead Employees and Contractors:
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