For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

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.

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.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Safety Science is a core function within Gilead's Patient Safety organization. Safety Science provides critical strategic input into cross-functional drug development planning and execution across the product lifecycle, from discovery to post-marketing. Safety Science performs continuous and proactive medical surveillance and benefit-risk evaluation for all of Gilead's therapies throughout their lifecycle. Among its many responsibilities, Safety Science provides scientific and medical input on all safety issues, identifies, and manages safety signals using internal and external safety data sources, leads authoring of or makes critical contributions into and reviews aggregate safety reports, prepares or approves Risk Management Plans (RMPs), leads the Gilead Structured Assessment of Benefit-Risk (G.SABeR), and safety-related regulatory responses for all products, compounds and indications across Gilead's therapeutic areas, including key quality checks. Safety Science also leads relevant PV processes and provides medical monitor support for non-interventional post-marketing studies.

POSITION OVERVIEW:

You will perform core safety science activities, including signal detection, development of benefit-risk evaluation management plans, risk minimization activities, leading the authoring of, or contributing input into aggregate safety reports, providing safety science input into study-related activities and documents and regulatory submissions, and providing the safety science perspective into PV processes, to ensure these are completed in a timely and quality manner, or provide oversight of these tasks if outsourced. You will provide safety science input into clinical trial protocols, develop appropriate regulatory responses, and provide the safety science perspective in PV audits and inspections. You will perform some of these responsibilities with supervision from a more experienced Safety Scientist or Physician. You will help ensure that safety documentation is stored appropriately and provide support for inspections and audits.

EXAMPLE RESPONSIBILITIES:

• Authors or otherwise contributes to the preparation of aggregate safety reports, including DUSRs and PBRERs and G.SABeRs, and RMPs.

• Conducts signal detection and evaluation activities for assigned products in collaboration with the Safety Physician as part of the continuous benefit-risk evaluation throughout the product lifecycle.

• Conducts literature review for assigned molecules.

• 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.

• May contribute to Safety Science 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.

• Performs safety reviews of clinical trial protocols, Investigator’s Brochures, clinical study reports, informed consent forms, and other study related documents.

• Participates on Patient Safety (PS) and cross-functional teams, including Safety Science functional area support in PV audits and inspections.

• May contribute to and provide the safety science perspective into PV process updates.

• 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.

U.S. Education & Experience

• PharmD/PhD in a scientific field.

• MA/MS/MBA with 6+ years’ relevant experience.

• BA/BS with 8+ years’ relevant experience.

• Drug safety or related experience in the biopharma industry, at a regulatory agency, clinical research, or related medical / healthcare environment.

• Experience in drug safety signal detection and benefit-risk evaluation with oncology experience preferred.

• Experience working with aggregate safety reports with oncology experience preferred.

• Experience developing risk management plans and risk minimization with oncology experience preferred.

Knowledge & Other Requirements

• Demonstrated ability to be a fast learner.

• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.

• Knowledge of worldwide PV regulations and their application to safety science.

• Experience of patient safety oncology therapeutic area preferred.

• Strong knowledge of the drug development process and understanding of and appropriate application of principles, concepts, practices, and standards of drug safety signal detection and management, Good Clinical Practices (GCP) and Good Pharmacovigilance (GVP).

• Knowledge of MedDRA applications / uses.

• Demonstrates ability to analyze and resolve complex problems collaboratively with cross-functional colleagues, including ability to assess data sets and understand the safety / clinical implications.

• Strong interpersonal skills and understanding of team dynamics.

• Proven ability to work successfully in a team-oriented, highly matrixed environment.

• Strong communication and writing skills, project management skills and proficiencies with Microsoft Office suite, as evidenced through abilities to assume assignments and projects with increasing independence.

• When needed, ability to travel.

The salary range for this position is: $169,320.00 - $219,120.00. 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.

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 ApplicantAccommodations@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) 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 Current Gilead Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.