Sr Clinical Trials Manager

Regulatory Jobs; Foster City (CA); Híbrido; USD 158.000 - 204.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Bonus program

Stock incentives

Paid time off

Benefits package

Descripción de la vacante

Gilead Sciences Inc. in Foster City seeks a Senior Clinical Trials Manager to lead Phase I–IV studies, ensure compliance with SOPs and regulatory requirements, and deliver high-quality data for registration and commercialization. This hybrid role requires 3 days on-site (Tue–Thu) and collaboration across Clinical Operations.

The position emphasizes study planning, cross-functional leadership, risk mitigation, and vendor management to support timely program delivery and quality data generation.

Formación

• BA/BS with 6+ years of clinical or life sciences experience; or MA/MS with 4+ years.
• Comprehensive knowledge of FDA, EMA, ICH guidelines, and GCP requirements governing clinical studies.

Responsabilidades

• Lead all aspects of assigned clinical studies within a program and lead Study Management Team as applicable.
• Develop, implement, and oversee study plans, timelines, budgets, and resourcing.
• Ensure studies are delivered on time, within budget, and in compliance with quality, protocol, SOP, and regulatory requirements.
• Identify study risks and drive mitigation and issue-resolution strategies.
• Lead CRO and vendor selection, oversight, deliverable management, and relationship management as applicable.
• Partner with cross-functional stakeholders to align on study objectives, priorities, timelines, and deliverables.
• Provide guidance, training, and direction to internal team members, CROs, vendors, and investigators.
• Mentor and support the development of less experienced colleagues.
• Contribute to process improvement, standardization, operational excellence, and departmental initiatives.

Conocimientos

Clinical operations

Budget management

Cross-functional leadership

Regulatory compliance

Vendor management

Educación

BA/BS with 6+ years life sciences

MA/MS with 4+ years life sciences

Descripción del empleo

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

Clinical Operations leads the global execution of Phase I–IV clinical trials across therapeutic areas, ensuring studies are conducted in compliance with SOPs, company policies, and regulatory requirements while delivering timely, high-quality data to support registration and commercialization.

The Senior Clinical Trials Manager leads studies within a program, provides direction to Clinical Operations team members, and is accountable for execution against timelines, budgets, and quality standards. This role develops study operational strategies and may contribute to cross-functional or organizational initiatives.

This is a Hybrid position, 3 days on-site (Tues -Thurs). Will not consider fully remote candidates.

Responsibilities:

• Lead all aspects of assigned clinical studies within a program, including Study Management Team leadership as applicable.
• Develop, implement, and oversee study plans, timelines, logistics, budgets, and resourcing.
• Ensure studies are delivered on time, within budget, and in alignment with quality, protocol, SOP, and regulatory requirements.
• Identify study risks and proactively drive mitigation and issue-resolution strategies.
• Lead CRO and vendor selection, oversight, deliverable management, and relationship management as applicable.
• Partner with cross-functional stakeholders to align on study objectives, priorities, timelines, and deliverables.
• Provide guidance, training, and direction to internal team members, CROs, vendors, and investigators.
• Mentor and support the development of less experienced colleagues.
• Contribute to process improvement, standardization, operational excellence, and departmental initiatives.

Basic qualifications:

• BA/BS with 6+ years of relevant clinical or related life sciences experience; or MA/MS with 4+ years of relevant clinical or related life sciences
• experience.
• Comprehensive knowledge of FDA, EMA, other applicable national regulations, ICH guidelines, and GCP requirements governing clinical studies.

Preferred qualifications:

• Advanced degree such as MA/MS, PharmD, or PhD in a life sciences or related field.
• Experience leading clinical studies and cross-functional project teams.
• Demonstrated ability to lead teams, coach, and mentor less experienced colleagues.
• Clear, concise communication skills and strong interpersonal effectiveness.
• Proven ability to work successfully in a team-oriented, highly matrixed environment.
• Strong knowledge of full-cycle study management, from start-up through close-out.
• Advanced knowledge of study management best practices and tools, with demonstrated ability to improve study efficiency and effectiveness.
• Ability to travel as needed.

The salary range for this position is: $157,590.00 - $203,940.00. 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:

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 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 [e-mail] for assistance.

For more information about equal employment opportunity protections, please view the'Know 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.

For Current Gilead Employees and Contractors: