Assoc Director, Clinical Operations, Clinical Site Partner (Inflammation)

Benefits

Additional Information

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 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 will be responsible for establishing and maintaining relationships with active and potential investigator sites to optimize delivery of clinical trial programs for an assigned therapeutic area, inclusive of site identification and qualification, enrollment planning and execution, timely delivery of database lock and study close out. You will also serve as an effective communication bridge between investigator sites and the Gilead Development organization and a point of escalation for both Gilead and investigator site staff, including partnering with Gilead and investigator site staff to resolve issues and remove barriers as needed. You will also be responsible for establishing and managing relationships with regional / local patient advocacy groups (PAGs) and communities ensuring incorporation of the patient perspective and voice across the continuum of product development. ** Only candidates based in the Mid-West Region will be considered ** Job Responsibilities Establish and maintain strong professional and collaborative relationships with investigator sites by leveraging disease area expertise to optimize delivery of clinical trial programs. Develop strategies to drive concierge level support for preferred sites to ensure Gilead becomes the Sponsor of Choice. Track key performance metrics to assess site performance and identify opportunities for acceleration and continuous improvement. Establish and manage strong working partnerships with local PAGs and communities, including liaising with patient groups in relation to protocol development and study design considerations. Serve as an internal resource to champion and promote an environment that incorporates the patient perspective and voice across the continuum of product development based on patient insights obtained from local PAGs and communities. Identify investigator sites, PAGs and communities in alignment with portfolio strategy and priority to expand Gilead's clinical research partnership network. Maintain therapeutic and technical expertise to enable scientific discussions with the investigator and site personnel. Share ongoing information with investigators, PAGs and communities regarding Gilead's development pipeline and collect and report field-based intelligence in relation to competitive landscape, patient treatment pathways and other operational considerations that may impact Gilead's clinical trial program. Provide support to study teams and Clinical Research Organizations (CROs) to ensure timely delivery of clinical trials from initiation to closeout such as during feasibility, site recommendations, attendance at initiation visits, facilitation of communication and ongoing support of trial enrollment by engaging with site staff to identify enrollment barriers and working with study teams to find solutions. Support the development and implementation of applicable site risk plans to ensure achievement of key study and site level milestones such as first patient first visit, delivery of clinical trial enrollment commitments and database lock. Serve as a local point of escalation for investigator sites and partner with the appropriate parties to resolve issues and remove barriers to clinical trial execution at a site and/or country level. Proactively communicate and escalate issues identified at investigator sites and partner with internal functional areas to