Assoc Clinical Development Director

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 Lead or contribute to protocol development, study concept design, and protocol amendments. Review and approve key clinical documents including: Protocols Investigator Brochures Informed Consent Forms Statistical Analysis Plans Risk mitigation plans Clinical Study Reports Ensure scientific rigor and medical relevance of development programs. Scientific Communication Present clinical data to internal governance bodies and development teams. Review or contribute to abstracts, manuscripts, conference presentations, publications and advisory board materials, etc. Represent the company in scientific interactions with investigators, KOLs, and external experts. Regulatory Strategy and Health Authority Interactions Regulatory Support Provide clinical support for: Pre-IND/IND submissions Pre-NDA/BLA, NDA/BLA submissions Health authority meetings Regulatory briefing packages Responses to regulatory questions Collaborate with Regulatory Affairs to develop China registration strategies. Participate in interactions with NMPA/CDE and other regulatory agencies as required. Support development of benefit-risk arguments and clinical justification packages. Cross-Functional Leadership Serve as the clinical representative on global and regional project teams. Collaborate closely with: Clinical Operations Regulatory Affairs Project Management Biostatistics Patient Safety Clinical Pharmacology Biomarker and Diagnostics Medical Affairs Provide strategic clinical guidance to study teams and CRO partners. Qualifications Education MD or equivalent medical degree required. Specialty training in Oncology, Hematology, Immunology, Hepatology, or other relevant therapeutic areas preferred. Experience MD with 5&#43; years of pharmaceutical industry and/or clinical research experience. Demonstrated experience as a Medical Monitor or Clinical Research Physician. Experience supporting and leading Phase I-III regional or global clinical development programs. Track record of successful regulatory interactions and major submissions. Demonstrated contributions to development strategy and portfolio decision-making. Prior experience as a practicing physician is a plus. Preferred Competencies Scientific Leadership Strong understanding of: drug development clinical trial methodology oncology/immunology/inflammation therapeutic areas translational medicine biomarker-driven development Strategic Thinking Ability to integrate the following into development strategy: medical need regulatory requirements competitive intelligence commercial considerations Regulatory Expertise Strong knowledge of: ICH-GCP NMPA/CDE regulations FDA regulations EMA regulations Leadership and Influence Ability to influence global development decisions without direct authority. Excellent communication, stakeholder management, and matrix leadership skills. <br