Director, Patient Safety (MD)

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

Summary:

We are seeking a highly motivated and strategic Patient Safety Medical Review Physician (MD) to provide medical leadership and oversight of individual case safety report review activities across marketed and investigational products. This role is critical to delivering timely high-quality medical safety assessments that support patient safety informed benefit-risk evaluation and regulatory compliance.

The Director will serve as a recognized expert in medical safety assessment and play a key leadership role in advancing the quality consistency and effectiveness of Medical Review activities. This includes overseeing peer retrospective medical review quality control (MRQC) activities supporting audits and inspections and driving the continued development and refinement of medical review processes standards practices efficiencies and capabilities.

As a medical review subject matter expert the Director will provide medical consultation and strategic guidance to cross-functional partners. The successful candidate will bring strong clinical judgment leadership presence and communication skills with a demonstrated ability to influence stakeholders lead initiatives and collaborate effectively across teams in a dynamic fast-paced and deadline-driven environment.

Key Responsibilities:

• Establishes recognition as an expert on medical safety assessment of individual cases and line listings.
• Performs peer retrospective medical review quality control activities.
• Responds to medical review-related questions from other functions in a timely manner.
• Collaborates with global safety leads and global safety strategy leads in assessment and communication of suspected unexpected serious adverse reactions (SUSARs) reports from clinical trials.
• Provides medical consultation to Patient Safety Strategic Operations functional groups including Literature Management Coding Strategy and Auto labeling Management on an ad hoc basis.
• Makes significant contributions to the ongoing development and refinement of medical review processes standards practices efficiencies and capabilities.
• May lead or contribute to develop and maintain procedural document for medical review activities and provide training.
• Supports internal and external audit and inspection.
• Participates in both internal and external educational initiatives.
• Makes contributions to process improvement within Patient Safety particularly with adverse event processing and operational aspects.
• Initiates leads or contributes to functional or cross-functional projects.
• Ensures own work complies with established practices policies and processes and any regulatory or other requirements.
• Provides mentorship and trains junior staff new hires and contractors to independently review adverse event reports for investigational and marketed products.

Basic Qualifications:

• An MD/DO degree or equivalent.

Preferred Qualifications:

• Completion of an accredited medical or surgical residency program. Board certification is preferred.
• minimum of 4 years experience in medical review or
• OR an applicable role in the pharmaceutical industry with strong knowledge of global regulatory requirements.

• Excellent scientific clinical and analytical knowledge base with ability to assess individual case safety reports and understand the safety/medical implications.
• Exceptional communication collaboration and project management skills.
• High attention to detail scientific rigor and a proactive solutions-oriented mindset.

People Leader Accountabilities:

• Create Inclusion - recognize the business value of diverse teams modeling inclusion and embed 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 employees are receiving the feedback and insight needed to grow develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals purpose and organizational objectives 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: $243100.00 - $314600.00. 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:

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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YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

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.