Clinical Operations Job Description

About Gilead

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.

How You Will 'Create Possible'

• 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, as well to speeding up site closure process.
• 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.
• Collaborate with study team and Clinical Research Organizations (CROs) to communicate with GCP institution and coordinate the authority inspection (such as NMPA inspection) preparation and onsite inspection.
• 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 develop corresponding mitigation strategies and recommended approaches, including participation in development and implementation of solutions to address issues.
• Leverage and present metrics to inform site / country / regional level decision making.
• Develop local knowledge of investigator site capabilities and past performance and provide input into site-level recruitment forecasts, recruitment methodologies, monitor performance and take appropriate action to maintain timelines.
• Partner closely with internal Clinical Operations, Clinical Development and Medical Affairs to ensure effective communication and unified messaging to investigator sites, PAGs and communities.

Knowledge, Experience and Skills

• BA / BSc / RN with 8 or more years' relevant clinical or related experience in life sciences or MA / MSc / PharmD / PhD with 6 or more years' relevant clinical or related experience in life sciences.
• Combination of scientific/medical expertise in a relevant therapeutic area, including knowledge of the clinical research landscape, and advanced knowledge of Clinical Operations.
• Strong working knowledge of Good Clinical Practice and in country regulatory guidelines and requirements.
• Strong self-management and organizational skills; ability to manage workload, set priorities and adjust as needed.
• Ability to work both independently and collaboratively.
• Excellent verbal and written communication and oral presentation skills (both in English and local language).
• Ability to establish and maintain strong long-term relationships with internal and external key stakeholders.
• Strong interpersonal skills and understanding of team dynamics.
• Strong leadership presence with demonstrated ability to lead without authority at all levels of internal and external stakeholders.
• Strong negotiation and conflict resolution skills.
• Demonstrated strategic agility and broad business acumen.
• Possess a combination of critical thinking and operational expertise and efficiency.
• Self-motivated with proactive issue monitoring and seeks opportunities to remove barriers.
• Extensive travel required.

Gilead Core Values

• Integrity (doing what's right)
• Teamwork (working together)
• Excellence (being your best)
• Accountability (taking personal responsibility)
• Inclusion (encouraging diversity)

Gilead Leadership Commitments

• I AM BOLD in aspiration and AGILE in execution.
• I CARE and make time for people.
• I LISTEN, speak openly and explain the "why."
• I TRUST others and myself to make sound decisions.
• I OWN the impact of my words and actions.

About the Role

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.