Associate Director, Patient Safety- Virology

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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

AtGileadour pursuit of a healthier world for all people has yielded a cure for hepatitis C revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the worlds most devastating diseases united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

Job Summary

The Associate Director Patient Safety-Virology provides strategic pharmacovigilance leadership for one or more products compounds or indications across the development and/or postmarketing lifecycle. This role contributes safety expertise to ensure continuous evaluation of benefitrisk profiles regulatory compliance and patient safety while serving as a key Patient Safety representative on crossfunctional teams.

The Associate Director operates with a high level of autonomy partnering across functions to support product development lifecycle management and postauthorization safety activities.

Key Responsibilities

• Provide scientific input into pharmacovigilance activities including safety surveillance signal detection and evaluation and benefitrisk assessments for assigned products and assisting with pharmacovigilance activities for other products when needed

• Contribute to the development and execution of safety strategies across the product lifecycle from clinical development through postmarketing

• Provide input into aggregate safety reports (e.g. PSURs/PBRERs DSURs) regulatory submissions and responses to health authority inquiries

• Support risk management activities including Risk Management Plans risk minimization measures and safetyrelated labeling updates.

• Contribute to activities related to regulatory filings and responses to safety queries from third parties such as regulatory agencies as needed

• Review of clinical study protocols amendments and studyrelated documents

• Represent Patient Safety on crossfunctional teams collaborating with Clinical Development Regulatory Affairs Medical Affairs RWE/HEOR and other functions

• Ensure pharmacovigilance activities are conducted in compliance with global regulations internal SOPs and quality standards

• Contribute to inspection readiness process improvement initiatives and the ongoing enhancement of Patient Safety operating models

• Build effective working relationships and provide thoughtful safety input to internal stakeholders to support patientcentric decisionmaking

Education and Experience Requirements

• PharmD/PhD with 2years relevant experience.

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

• BA/BS with 10 years relevant experience.

• Relevant experience in pharmacovigilance / patient safety within the pharmaceutical or biotechnology industry

• Working knowledge of global pharmacovigilance regulations and aggregate safety reporting requirements

• Demonstrated ability to evaluate safety data apply clinical judgment and communicate benefitrisk considerations

• Experience working effectively in crossfunctional matrix environments.

Preferred Qualifications

• Experience supporting safety oversight for products across multiple stages of the development or postmarketing lifecycle

• Prior involvement in safety signal evaluation risk management activities and regulatory interactions

• Strong written and verbal communication skills with the ability to present complex safety information to diverse stakeholders

• Ability to manage multiple priorities and products concurrently in a fastpaced environment

People Leader Accountabilities:

• Create Inclusion -knowingthe business value of diverse teams modeling inclusion and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills experience aspirations and potential of their employees and coach them on current performance and future potential. They ensure employeesare receivingthe feedback and insight needed to growdevelopand realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals purpose and organizationalobjectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

The salary range for this position is:

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:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic 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 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 theKnow Your Rights poster.

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Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

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.

Please apply via the Internal Career Opportunities portal in Workday.