Assoc Director, Clinical Operations

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
 

Key Responsibilities:

• Provides input into strategic and operational short- and long-range therapeutic area / functional area plans as appropriate, including supporting alignment and communications to other team members upon implementation.
• Provides leadership, guidance, oversight and therapeutic expertise for the successful management of all aspects of clinical trials.
• Responsible for the strategic, operational and financial oversight of assigned program(s).
• Develops, implements, manages and ensures completion of clinical trials within designated budgets and timelines.
• Sets the strategic vision for assigned clinical trials / programs by working cross-functionally with all relevant stakeholders.
• Assesses, on-boards and manages contract research organizations (CROs) and other vendors to ensure success of assigned trials / programs, including requests for proposals (RFPs) and selection processes.
•  Contributes to the strategic implementation of Clinical Development Program(s) for specific programs as a member of the Clinical Sub-Team and may sit on the Global Development Team, dependent upon the program’s priority and breadth.
• Leads cross-functional Study Management Teams (SMTs) and influences all relevant stakeholders.
•  Performs strategic analysis of project status and issues; ensuring robust risk mitigation strategies are in place.
• Anticipates complex obstacles and implements solutions to achieve project goals.
• Solves problems relating to national and international regulations, guidelines and investigator interactions.
•  Keeps all stakeholders appropriately and timeously advised on all aspects of project status and any issues.
• Uses all available tools to track, oversee and communicate on program status to all key stakeholders.
•  Contributes leadership input into all study-related documentation, including study protocols.
• Responsible for Clinical Operations activities conducted by the affiliate that are required by local regulations and/or usual practice to support clinical trials.
• Initiates, authors or otherwise contributes to standard operating procedure (SOP) development, implementation and training.
• Ensures team’s work complies with established practices, policies and processes, and any regulatory or other requirements.
• People Leader Path: Hires, develops and retains diverse top talent on the team. Sets clear expectations for the team and individuals direct reports. Coaches direct reports on their performance, development and career interests. May play a central role in developing other people leaders

Basic Qualifications:

Bachelor's Degree and Ten Years' Experience

OR

Masters' Degree and Eight Years' Experience

OR

PhD/PharmD and 2 Years' Experience

Preferred qualifications:

• Prior oncology clinical trials experience with at least 3+ years’ experience in the design and delivery of Phase 1 first‑in‑human (FIH) oncology clinical trials.

• Relevant clinical or related experience in life science
• Typically has a minimum of 6 years’ cross-functional study management or related leadership experience in life sciences, including multiple years’ experience managing study management or project teams.
• Experience developing RFPs and selection and management of CROs or other vendors.
• Proven ability to successfully manage clinical studies within designated program budgets and timelines, including significant expertise in authoring clinical study and regulatory documentation and SOPs.

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.

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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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.