Director, Patient Safety

Job Description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

We empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together.

Job Description

FUNCTION: Medical Safety Science (MSS) / Global Therapeutic Area (TA) Safety Scientists

POSITION OVERVIEW:

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 other advanced MSS 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 on behalf of MSS 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 Global Safety Lead (GSL); 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 within MSS 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 MSS 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 MSS 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 MSS 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 Global Patient Safety (GLPS) and cross-functional teams, including leadership of special projects, participation in continuous improvement and optimization initiatives, and MSS functional area 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.

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

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.

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 for assistance.

For more information about equal employment opportunity protections, please view the ‘Know Your Rights’ 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.

For jobs in France:

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