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For 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.

Job Description

Gilead’s Patient Safety team is seeking an experienced Associate Director to support the development, filing and marketing of a broad and innovative cancer immunotherapy pipeline, including partnerships with external companies.

Working as part of a diverse team of MDs and non-MDs within Patient Safety, the ideal candidate will offer excellent cross-functional working skills in order to champion the voice of patients in development programs spanning all phases of development, filing for market authorization and support of marketed molecules.

The candidate should be able to implement benefit-risk activities, contributing where possible to design and strategy within cross-functional and cross-company networks. As a member of the safety team, experience of working in small agile teams to address benefit-risk challenges will be important. Putting the patient first and engaging in the friendly and open culture of the team, the ideal candidate will bring a collaborative, agile and positive spirit to advocate for patient safety.

POSITION OVERVIEW:

You will develop and ensure that strategic scientific input relative to safety is incorporated into product development and lifecycle management as well as perform other safety activities for one or more products in the assigned therapeutic area.

You will ensure that signal detection, development of benefit-risk evaluation management plans and risk minimization activities, authoring of aggregate safety reports and safety-related responses to regulatory inquiries are performed in a timely and quality manner. You may represent Patient Safety Oncology on cross-functional teams. You will provide Patient Safety Oncology input into study-related activities and documentation, regulatory submissions, and pharmacovigilance (PV) processes and projects. You will also mentor less experienced colleagues.

EXAMPLE RESPONSIBILITIES:

• Makes contributions to clinical development and/or medical strategies, including Patient Safety Oncology guidance into clinical trial design.

• Authors and/or oversees the preparation of aggregate safety reports and risk management plans (RMPs).

• Conducts 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.

• As needed, contributes to Patient Safety Oncology 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 cross-functional teams, including Patient Safety Oncology functional area support in PV audits and inspections.

• May serve as medical monitor for post-authorization safety studies.

• May provide matrix management and leadership to project teams.

• 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 with 2+years’ relevant experience.

• MA/MS/MBA with 8+ years’ relevant experience.

• BA/BS with 10+ years’ relevant experience.

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

• Significant experience in drug safety signal detection, benefit-risk evaluation and authoring drug safety risk management plans and aggregate safety reports is preferred.

• Significant experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities.

Knowledge & Other Requirements

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

• Thorough knowledge of the drug development process, Good Clinical Practices (GCP) and Good Pharmacovigilance (GVP), including all key functions involved in the various stages of drug development from early research through postmarketing.

• Demonstrates advanced scientific / clinical knowledge and analytical skills, as evidenced by strengths in assessing complex data sets and understanding the safety / clinical implications.

• Proven abilities to anticipate problems of varying complexity and lead the resolution of these in a collaborative manner across functions. Demonstrated ability to work effectively in cross-functional teams and projects, as evidenced by past successful cross-functional collaboration.

• Strong interpersonal skills and understanding of team dynamics.

• 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.

• Strong negotiation and conflict resolution skills.

• When needed, ability to travel.

The salary range for this position is: $185,895.00 - $240,570.00. 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 careers@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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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.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all Canada, Australia, Singapore, and Hong Kong employees and contractors to be fully vaccinated against COVID-19 as a condition of employment. T he health of our employees, contractors, their loved ones, our partners and the communities and people we serve is a top priority. Vaccination is the most effective way currently available to deliver on that priority.

The purpose of the vaccination requirement is to minimize the spread of COVID-19 in the workplace and support the health and safety of our communities. A person is considered fully vaccinated two weeks after the second dose of a two-dose vaccine or two weeks after 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 an accommodation.