Clinical Trials Manager, Early Phase

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 plays a key role in ensuring that Gilead clinical trials are conducted in compliance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead’s products.

You will manage a geographical region(s) of assigned clinical studies or multiple components of larger studies. You will manage Phase I studies involving multiple vendors, develop and incorporate study logistics and study plans to accomplish clinical study objectives. You may also participate in strategic initiatives / projects.

Key Responsibilities:

• Manages Phase I clinical studies, including studies conducted across multiple geographic regions and involving multiple vendors.

• Manages study budgets and provides proactive financial oversight to ensure alignment with study forecasts and business objectives.

• 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 assigned studies, providing oversight of site evaluation, initiation, conduct, and close-out activities.

• Defines study logistics and oversees/ develops clinical study plans for assigned clinical studies.

• 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.

• May contribute to SOP development and/or participates in special projects. Develops tools and processes that optimize project efficiencies and effectiveness.

• Provides input into study protocols, and informed consents, oversees/authors study plans, and presentations.

• Provides oversight of study 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 of safety, 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 all work is conducted in accordance with established practices, policies and processes, and any regulatory or other requirements.

Basic qualifications:

• 5+ Years with BS/BA
• 3+ Years with MS/MA

Preferred Qualifications:

• MA / MS / PharmD / PhD with 3+ years’ relevant clinical or related experience in life sciences.

• BA / BS / RN with 5+ 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. 
• Demonstrated ability to be a fast learner.

• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.

• Ability to manage any component of full cycle study management, from start-up to close-out.

• Advanced knowledge of study management best practices and tools and has shown ability to apply these to improve study efficiencies and effectiveness.

• Fully understands protocol requirements and effectively articulates and interprets these.

• Knowledge of Food & Drug Administration (FDA), European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies.

• Familiar with standard medical / scientific terminology.

• Ability to communicate in a clear and concise manner.

• Ability to support a team-oriented, highly-matrixed environment.

• Ability to execute multiple tasks as assigned.

• When needed, ability to travel.

• Create Inclusion - knowing the 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 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: $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 [email protected] for assistance.

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

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