Associate Director, Clinical Site Partner, Clinical Operations, Oncology

Role Summary

The Associate Director, Clinical Site Partner, Oncology will establish and maintain relationships with active and potential investigator sites to optimize delivery of oncology clinical trial programs, including site identification and qualification, enrollment planning and execution, and timely delivery of database lock and study close out. They will serve as an effective communication bridge between investigator sites and the Gilead Development organization and act as a point of escalation for both Gilead and investigator site staff, partnering to resolve issues and remove barriers. They will also establish and manage relationships with Gilead’s preferred network of sites within their region. Geography: Southeast / Mid-Atlantic.

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.
• Identify investigator sites 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 regarding Gilead's development pipeline and collect and report field-based intelligence related 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 study start-up to close-out, including feasibility, site recommendations, initiation visits, and ongoing enrollment support by engaging with site staff to identify enrollment barriers and collaborate on solutions.
• Gather constructive feedback and insights from clinical sites to share with internal stakeholders for program improvements.
• Support the development and implementation of site risk plans to achieve key study and site milestones such as first patient first visit, 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 trial execution at site and country levels.
• Proactively communicate and escalate issues identified at investigator sites and collaborate with internal functional areas to develop mitigation strategies and solutions.
• Leverage and present metrics to inform site, country, and regional decision making.
• Develop local knowledge of investigator site capabilities and past performance and provide input into site-level recruitment forecasts and performance monitoring to maintain timelines.
• Partner closely with internal Clinical Operations, Clinical Development, and Medical Affairs to ensure effective communication and unified messaging to investigator sites.
• Geography: Southeast / Mid-Atlantic assignments as required.

Qualifications

• Required: Bachelor's Degree and Ten Years' Experience OR Master's Degree and Eight Years' Experience OR PhD/PharmD and Five Years' Experience
• Preferred: BA/BS/RN with 10+ years’ relevant clinical or related experience in life sciences; OR MA/MS/PharmD/PhD with 8+ years’ relevant experience.
• Combination of scientific/medical expertise in a relevant therapeutic area, including knowledge of the clinical research landscape, and advanced knowledge of Clinical Operations (Oncology experience is a bonus).
• 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.
• Established relationships and experience in both the community and academic site networks.
• Excellent verbal and written communication and oral presentation skills (English and local language).
• Ability to establish and maintain strong long-term relationships with internal and external stakeholders.
• Strong interpersonal skills and understanding of team dynamics.
• Strong leadership presence with the ability to lead without authority at various levels.
• Strong negotiation and conflict resolution skills.
• Demonstrated strategic agility and broad business acumen.
• Combination of critical thinking and operational efficiency.
• Self-motivated with proactive issue monitoring and the ability to remove barriers.
• Extensive travel required.

Education

• Bachelor's Degree (minimum)
• Master's Degree
• PhD / PharmD

Additional Requirements

• Extensive travel required.