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About the Role
This role serves as a communication bridge and escalation point between investigator sites and the Development organization. It manages relationships with patient advocacy groups and ensures the patient perspective is incorporated throughout product development. The position establishes and maintains strong relationships with investigator sites, leveraging disease area expertise to optimize clinical trial delivery.
Responsibilities
- Covers site identification and qualification, enrollment planning and execution, timely database lock, and study closeout.
- Serves as a communication bridge and escalation point between investigator sites and the Development organization.
- Works with internal teams and site staff to resolve issues and remove barriers.
- Manages relationships with regional and local patient advocacy groups and communities.
- Establishes and maintains strong professional and collaborative relationships with investigator sites.
- Develops strategies to provide high-touch support for preferred sites and strengthen the company’s position as a sponsor of choice.
- Tracks key performance metrics to assess site performance and identify opportunities for continuous improvement.
- Maintains therapeutic and technical expertise to enable scientific discussions with investigators and site personnel.
- Shares development pipeline information with investigators/site personnel and collects field-based intelligence.
- Supports study teams and CROs to deliver trials from initiation through closeout.
- Supports the development and implementation of site risk plans.
- Serves as a local escalation point for investigator sites.
- Partners with appropriate stakeholders to resolve issues and remove barriers at site and/or country level.
- Proactively communicates and escalates site issues.
- Partners with internal functional areas to develop mitigation strategies and implement solutions.
- Leverages and presents metrics to inform site, country, and regional decision-making.
- Develops local knowledge of site capabilities and past performance.
- Provides input into recruitment forecasts and methodologies while monitoring performance and taking action to maintain timelines.
- Partners closely with Clinical Operations, Clinical Development, and Medical Affairs to ensure effective communication and unified messaging to investigator sites.
Requirements
- 5+ years of Clinical Operations experience in a pharmaceutical company, biotech, or CRO
- Hands-on experience managing clinical trials from start-up through closeout
- Strong investigator site relationship management and engagement experience
- Experience with site feasibility, site selection, site activation, and enrollment support
- Proven ability to resolve site issues and manage escalations
- Strong understanding of ICH-GCP and local clinical trial regulations
- Experience using KPIs and performance metrics to drive trial execution
- Therapeutic area expertise in Oncology, Virology, or Inflammation/Immunology
- Ability to collaborate effectively with Clinical Operations, Clinical Development, Medical Affairs, and CRO partners
- Strong communication and stakeholder management skills
- Business-level English proficiency
- Native-level Japanese proficiency
- Experience as a Clinical Site Partner, Site Engagement Lead, Site Partnership Manager, or similar role
- Oncology clinical trial experience, particularly in complex or global studies
- Experience with patient recruitment acceleration and enrollment recovery initiatives
- Experience developing site risk mitigation and performance improvement strategies
- Experience working with Patient Advocacy Groups (PAGs) or patient communities
- Global clinical trial experience within a matrix organization
- Experience leveraging site and country-level metrics to support strategic decision-making
- Established relationships with key investigator sites and KOLs
- Experience collaborating closely with Medical Affairs and MSL teams
Skills
- Clinical Operations
- Clinical Trial Management
- Investigator Site Relationship Management
- Site Feasibility
- Site Selection
- Site Activation
- Enrollment Support
- Issue Resolution
- Escalation Management
- ICH-GCP
- Clinical Trial Regulations
- KPIs
- Performance Metrics
- Oncology
- Virology
- Inflammation/Immunology
- Collaboration
- Communication
- Stakeholder Management
- Patient Advocacy Groups
- Risk Mitigation
- Performance Improvement
- Global Clinical Trials
- Matrix Organization
- Strategic Decision-Making
- KOL Relationships
- Medical Affairs
- MSL Teams
Experience Level
- 5+ years of Clinical Operations experience
Education Level
- Advanced degree in Life Sciences, Pharmacy, Nursing, or a related field
About the Company
- 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.