【1200～1500万円】Clinical Site Partner Clinical Operations

【求人No NJB2411567】
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

The role covers site identification and qualification enrollment planning and execution timely database lock and study closeout.
The position serves as a communication bridge and escalation point between investigator sites and the Development organization working with internal teams and site staff to resolve issues and remove barriers.
The position also manages relationships with regional and local patient advocacy groups and communities to ensure that the patient perspective is incorporated throughout product development.
・ Establish and maintain strong professional and collaborative relationships with investigator sites leveraging disease area expertise to optimize clinical trial delivery.
・ Develop strategies to provide high touch support for preferred sites and strengthen the company’s position as a sponsor of choice.
・ Track key performance metrics to assess site performance and identify opportunities for and continuous improvement.
・ Maintain therapeutic and technical expertise to enable scientific discussions with investigators and site personnel.
・ Share development pipeline information with investigators/site personnel and collect field based intelligence on the competitive landscape patient pathways and operational considerations.
・ Support study teams and CROs to deliver trials from initiation through closeout including feasibility site recommendations initiation visits communication facilitation and enrollment support.
・ 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 escalation point for investigator sites partnering with appropriate stakeholders to resolve issues and remove barriers at site and/or country level.
・ Proactively communicate and escalate site issues and partner with internal functional areas to develop mitigation strategies and implement solutions.
・ Leverage and present metrics to inform site country and regional decision making.
・ Develop local knowledge of site capabilities and past performance and provide input into recruitment forecasts and methodologies while monitoring performance and taking action to maintain timelines.
・ Partner closely with Clinical Operations Clinical Development and Medical Affairs to ensure effective communication and unified messaging to investigator sites.
・ Therapeutic Area: Oncology Virology and Inflammation disease

Required Qualifications:
・ 10+ 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 and native level Japanese proficiency

Preferred Qualifications:
・ 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
・ 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
・ Advanced degree in Life Sciences Pharmacy Nursing or a related field