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
POSITION OVERVIEW:
Clinical Operations 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.
You may lead clinical studies within a program. You will provide guidance and oversight to assigned Clinical Operations team members to ensure successful management of all aspects of clinical studies within designated program budgets and timelines. You will define and incorporate study logistics and study plans to accomplish clinical study objectives. You may also participate in strategic initiatives / projects.
EXAMPLE RESPONSIBILITIES:
Leads and oversees all components of assigned studies in partnership/collaboration with Clinical Program Managers.
Manages actively clinical study budgets and exercises proactive financial oversight.
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.
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.
Provides guidance and training to team members, CROs, vendors, and investigators on study requirements.
Defines, develops, and oversees adherence to study timelines, including documentation and communications.
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 initiate, author, or otherwise contribute to SOP development and implementation.
Participates in special projects.
Presents at internal and external meetings.
Provides input into study protocols, case report forms, and informed consents, oversees/authors study plans, and presentations.
Assists in training new or less experienced colleagues.
Ensures own and team’s work complies with established practices, policies and processes, and any regulatory or other requirements
Minimum Education & Experience:
10+ years’ relevant clinical or related experience in life sciences.
Multiple years’ clinical or related experience in life sciences, including multiple years’ experience leading studies and project teams.
Demonstrated abilities to effectively lead and manage a team and/or effectiveness coaching and mentoring less experienced colleagues.
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
Please apply via the Internal Career Opportunities portal in Workday.