Assoc Clinical Development Director

Job description

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+ 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. 临床开发副总监/总监（肿瘤/炎症方向） 职位概述 临床开发副总监/总监（肿瘤/炎症方向）将负责为相关治疗领域内的临床开发项目及临床研究提供医学与科学领导力。该岗位将同时承担医学监查职责，并作为中国开发策略的核心贡献者，推动全球开发目标与中国临床实践、监管要求及竞争环境有效衔接。 该岗位将在药物开发全生命周期中提供战略性科学输入，负责监督受试者安全、医学数据质量及关键临床决策支持；同时与全球、区域及中国跨职能团队紧密协作，支持产品在中国的高质量开发、注册申报及上市路径推进。 1.中国临床开发策略 战略制定与开发领导主导或参与制定并执行所负责资产及适应症的中国临床开发策略。 系统评估中国疾病负担、治疗格局、未满足医疗需求、竞争态势及治疗标准变化，识别并推动潜在开发机会。 就中国参与全球开发项目提供临床、科学及注册策略方面的专业建议。 评估中国特异性研究、桥接策略、剂量合理性论证及注册路径的必要性与可行性。 影响并优化全球开发计划，促进全球与中国开发及注册进程的协同推进。 从临床开发视角支持产品组合评估、生命周期管理及业务发展相关医学评估。 外部环境洞察与学术合作持续跟踪中国及全球新兴临床数据、竞争情报、诊疗指南及监管趋势，并将相关洞察转化为开发策略输入。 建立并维护与关键意见领袖（KOL）、研究者、协作组及学术机构的专业合作关系。 识别研究者参与、科学合作及外部专家咨询机会，以支持临床开发目标达成 2.医学监查与临床研究监督 医学监查职责担任所负责临床研究的医学监查员，提供全程医学监督与科学支持。 保障受试者安全、研究执行质量及临床数据的科学完整性。 审阅受试者入排标准符合性、方案偏离、重要医学事件及关键临床判断事项。 开展个体受试者层面及汇总层面的医学数据审阅，识别潜在临床趋势和风险信号。 综合评估疗效、安全性、实验室检查、PK/PD、生物标志物及患者报告结局等关键数据。 识别可能影响获益-风险评估、研究推进或开发决策的数据趋势。 在期中分析、数据清理和数据库锁定阶段，领导或支持医学审阅相关工作。 参与安全性审阅会议、剂量递增讨论、DMC/IDMC会议以及研究治理委员会会议。 回应研究者关于方案解读、入组标准、患者管理及安全性事项的医学咨询。 为研究团队、研究中心及CRO合作伙伴提供持续医学培训和临床指导。 安全性监测与获益-风险评估持续审阅SAE、AESI、死亡事件及新出现的安全性信号。 与患者安全、药物警戒及相关职能团队协作，开展持续获益-风险评估。 确保潜在安全性问题得到及时识别、升级、沟通和管理。 参与安全性叙述、汇总安全性审阅、DSUR及监管问询回复等医学内容的撰写和审阅。 临床科学领导与文件审阅领导或参与研究概念设计、方案制定、方案修订及关键研究设计决策。 审阅并批准关键临床及医学文件，包括但不限于： 研究方案 研究者手册 知情同意书 统计分析计划 风险缓解计划 临床研究报告 确保临床开发项目具备充分的科学严谨性、医学合理性及可执行性。 科学沟通与外部交流向内部治理委员会、项目团队及开发决策机构汇报临床数据、医学判断及关键风险。 审阅或参与摘要、论文、会议报告、医学发表及顾问委员会材料等科学沟通内容的撰写。 代表公司与研究者、KOL及外部专家开展高质量科学交流。 3.注册策略与药政沟通支持 注册申报与药政互动为以下注册相关活动提供医学和临床开发支持： Pre-IND/IND申报 Pre-NDA/BLA、