About this role
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 Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercialises innovative medicines in areas of unmet medical need. With each new drug discovery and investigational candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include liver viral illnesses, inflammatory diseases, and cancer.
Position Overview CTM is responsible for the worldwide execution 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 high-quality clinical data that supports global registration and commercialization of Gilead’s products. Job Responsibilities Provide guidance and daily oversight for the successful management of all aspects of Phase I to IV within designated program budgets and timelines Typically serves as the key operational contact for Gilead studies, providing oversight for the site evaluation, initiation, and close-out visits in addition to routine monitoring visits, either directly or through CROs Participates in and manages project meetings and conference calls with CROs, other vendors and cross-functional teams Provide guidance and training to CROs, vendors, investigators and study coordinators on study requirements Resolve issues using national and international regulations, guidelines, and investigator interaction Leads or otherwise assists in the preparation of safety, interim and final study reports, including resolving any data discrepancies.
Drafts and/or reviews relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports Participates in multiple departmental or interdepartmental strategic initiatives under limited supervision Domestic and/or International travel is required Essential Duties To serve as the local Clinical Operations representative and point of contact for key stakeholders of the responsible project To collaborate with study team across the world and CRO to meet the cross functional study timelines and troubleshoot country/site specific operations issues To conduct or support site/country feasibility assessment and site selection To develop and make a good relationship with investigators and site staffs To leverage local knowledge and relationships and to work collaboratively with Gilead affiliate personnel (Medical Affairs, Regulatory, Patient Safety) to ensure optimal support for Gilead’s clinical development programs and to ensure relevant information from sites is triaged and communicated to the study teams and TA Leads as necessary To leverage local knowledge and relationships to ensure optimal support for Gilead’s clinical development programs and relevant information from sites is triaged and communicated to the study teams and TA Leads as necessary Specific Education & Experience Requirements: At least 9 years of experience in clinical trials and a BS/ BA/ RN in a relevant scientific discipline Excellent interpersonal skills and demonstrated ability to lead is required Working knowledge and experience with Word, PowerPoint and Excel 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. Complete knowledge 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. Significant industry knowledge, including knowledge of drug development.
Complete knowledge of country regulations/requirements, 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. Ability to communicate in a clear and concise manner. Ability to lead and influence programs, projects and/or initiatives.
Strong interpersonal skills and understanding of team dynamics. Proven ability to work successfully in a team-oriented, highly-matrixed environment. When needed, ability to travel For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.