Assoc Clinical Development Director

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About the role

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   Key Responsibilities • China Development Strategy Strategic Development Leadership • Contribute to the development and execution of China clinical development strategies for assigned assets and indications. • Evaluate China's treatment landscape, epidemiology, unmet medical needs, competitive environment, and evolving standards of care to identify development opportunities. • Provide scientific and clinical recommendations regarding China participation in global development programs. • Assess the need for China-specific studies, bridging strategies, dose justification, and registration pathways. • Influence global development plans to optimize simultaneous global and China registration. • Support portfolio evaluation, lifecycle management, and business development assessments from a clinical perspective. External Environment Assessment • Maintain deep understanding of emerging clinical data, competitive intelligence, treatment guidelines, and evolving regulatory expectations in China. • Establish and maintain strong relationships with key opinion leaders (KOLs), investigators, cooperative groups, and academic institutions. • Identify opportunities for investigator engagement and scientific collaboration to support development objectives. • Medical Monitoring and Clinical Trial Oversight Medical Monitoring • Serve as Medical Monitor for assigned clinical studies. • Provide ongoing medical oversight to ensure subject safety and scientific integrity. • Review subject eligibility, protocol deviations, and significant medical events. • Perform individual patient-level and aggregate data review. • Evaluate efficacy, safety, laboratory, PK/PD, biomarker, and patient-reported outcome data. • Identify data trends impacting risk-benefit assessment or development decisions. • Lead medical review activities during interim analyses and database locks. • Participate in safety review meetings, dose escalation discussions, DMC/IDMC meetings, and study governance committees. • Respond to investigator inquiries regarding protocol interpretation, eligibility criteria, patient management, and safety issues. • Provide the ongoing clinical training to the study team, CRO partners, etc. Safety Surveillance • Conduct ongoing review of SAE, AESI, deaths, and emerging safety signals. • Collaborate with Patient Safety and Pharmacovigilance teams in benefit-risk assessment. • Ensure timely identification, escalation, and management of potential safety concerns. • Contribute to safety narratives, aggregate safety reviews, DSURs, and regulatory responses. Clinical Science Leadership •

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