Clinical Trial Manager Clinical Operations- Inflammation

At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 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 lifechanging 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

POSITION OVERVIEW:

Clinical Operations is responsible for the worldwide of all Phase I IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs company policies and regulatory guidelines to provide timely and highquality clinical data that supports global registration and commercialization of Gileads products.

You will manage a geographical region(s) of assigned clinical studies or multiple components of larger studies. You will typically manage Phase I studies or other smaller studies. You will define and incorporate study logistics and study plans to accomplish clinical study objectives. You may also participate in strategic initiatives.

EXAMPLE RESPONSIBILITIES:

• Manages all components of small clinical studies including Phase I studies.
• With guidance may lead contract research organization (CRO) and vendor selection and where applicable manages all interactions and deliverables from relevant CROs and vendors.
• Typically serves as the key operational contact for Gilead studies; providing oversight for the site evaluation initiation and closeout visits in addition to routine monitoring visits either directly or through CROs.
• Defines and develops the study logistics and clinical study plan for assigned clinical studies.
• Manages study timelines including documentation and communications.
• Participates in and manages project meetings and conference calls with CROs other vendors and crossfunctional teams.
• 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 and case report forms authors informed consents study plans and presentations.
• Provides oversight of study sites/region and reviews routine regulatory documents to ensure that CROs are in compliance with protocols regulatory requirements SOPs and monitoring plans.
• 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 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:

We are all different yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience

• PharmD / PhD with 2 years relevant clinical or related experience in life sciences.
• MA / MS 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.

Knowledge & Other Requirements

• 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 startup to closeout.
• 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.
• Thorough 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 teamoriented highlymatrixed environment.
• Ability to execute multiple tasks as assigned.
• When needed ability to travel.

For additional benefits information visit:

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 disabilitygenetic information or characteristic gender identity and expression veteran status or other nonjob 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 for assistance.

For more information about equal employment opportunity protections please view theKnow Your Rights poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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:

Please apply via the Internal Career Opportunities portal in Workday.