Clinical Trials Manager

Gilead Sciences; Foster City (CA); On-site; USD 147,000 - 190,000; Full time

Job summary

Gilead Sciences Inc. in the United States seeks a senior Clinical Operations leader to oversee regional clinical studies, budgets, and CRO/vendor management. You will coordinate cross-functional teams to ensure study goals meet timelines and regulatory requirements.

Required: BA/BS or RN with 5+ years in life sciences, or MA/MS/PharmD/PhD with 3+ years; experience leading studies and external vendors. Strong communication and compliance skills are essential; salary and benefits are competitive.

Qualifications

• BA / BS / RN with 5+ years’ relevant clinical or related experience in life sciences.
• MA / MS / PharmD / PhD with 3+ years’ relevant clinical or related experience in life sciences.
• Multiple years’ clinical or related experience in life sciences, including experience leading or managing less complex studies and project teams.
• Experience managing the work of external vendors.

Responsibilities

• Manages a geographical region of assigned clinical studies, budgets, and CRO/vendor interactions.
• Leads or oversees CRO/vendor selection and manages interactions and deliverables.
• Oversees site evaluations, initiation, and close-out visits; conducts monitoring oversight.
• Develops study plans and timelines; ensures regulatory compliance and SOP adherence.

Skills

Clinical Operations

Budget oversight

Vendor management

CRO coordination

Cross-functional collaboration

Education

BA/BS or RN

MA/MS/PharmD/PhD

Job description

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

• Manages a geographical (region)s of assigned clinical studies, multiple components of larger studies, or all components of small clinical studies, including Phase 1 studies.

• Manages actively clinical study budgets and exercises proactive financial oversight.

• Collaborates with other functions on how to best achieve their study goals and objectives and communicates cross-functionally to ensure project team goals are met.
• With guidance, may lead contract research organization (CRO) and vendor selection and, where applicable, oversees and/or manages interactions and deliverables from relevant CROs, subcontractors, and vendors.
• Typically serves as the key operational contact for Gilead studies, providing oversight for the site evaluation, initiation, and close-out visits in addition to conducting oversight monitoring visits,

• Defines study logistics and oversees/ develops clinicalstudy plans for assigned clinicalstudies.
• Manages study timelines, including documentation and communications.

• Participates and/or acts as a Business Lead in initiatives / projects and manages project meetings and conference calls with CROs, other vendors and cross-functional teams as appropriate.

• Contributes to SOP development and/or participates in special projects. Develops tools and processes that optimize project efficiencies and effectiveness.
• Provides input into study protocols, case report forms, and informed consents, oversees/authors study plans, and presentations.

• Provides oversight ofstudy sites/region and reviews routine regulatory documents to ensure that CROs /vendors are in compliance with protocols, regulatory requirements, SOPs, and monitoring plans.

• Responsible for Clinical Operations activities conducted by the affiliate that are required by local regulations and/or usual practice to support clinical trials.
• May be required to present at internal or external meetings (i.e., investigator meetings).
• Leads or otherwise assists in the preparation ofsafety, interim and final study reports, including resolving any data discrepancies.

• Proactively identifies potential operational challenges and collaborates with other Clinical Operations’ colleagues to provide solutions to ensure study execution remains on track to defined protocols, budgets and timelines.

• Assists in training new or less experienced colleagues.
• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements

Requirements:

• BA / BS / RN with 5+ years’ relevant clinical or related experience in life sciences.
• MA / MS / PharmD / PhD with 3+ years’ relevant clinical or related experience in life sciences.
• Multiple years’ clinical or related experience in life sciences, including experience leading or managing less complex studies and project teams.
• Experience managing the work of external vendors.

The salary range for this position is: $146,540.00 - $189,640.00. 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] 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.

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Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.