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** **EXAMPLE RESPONSIBILITIES:** + Provides input into country strategic and operational short- and long-range therapeutic area / functional area plans as appropriate, including supporting alignment and communications to other team members upon implementation. + Provides leadership, guidance, oversight and therapeutic expertise for the successful management of all aspects of clinical trials. + Responsible for the strategic, operational and financial oversight of assigned program(s) within the country. + Develops, implements, manages and ensures completion of clinical trials within country designated budgets and timelines. + Sets the country strategic vision for assigned clinical trials / programs by working cross-functionally with all relevant stakeholders. + Assesses, on-boards and manages country contract research organizations (CROs) and other vendors to ensure success of assigned trials / programs, including requests for proposals (RFPs) and selection processes. + Contributes to the country strategic implementation of the global Clinical Development Program(s) for specific programs as a member of the Clinical Sub-Team, dependent upon the program’s priority and breadth for the country. + Participates in global Study Management Teams (SMTs) as needed and influences all relevant stakeholders as to country requirements and enrollment needs. + Performs country strategic analysis of project status and issues; ensuring robust risk mitigation strategies are in place. + Anticipates complex obstacles and implements solutions to achieve project goals. + Solves problems relating to country regulations, guidelines and investigator interactions. + Keeps all stakeholders appropriately and timeously advised on all aspects of project status and any issues. + Partners with the country General Manager and other key local stakeholders to ensure seamless execution. + Ensures building of strong local site partnerships (Sponsor Partner of Choice) through management of the Clinical Site Partners. + Uses all available tools to track, oversee and communicate on program status to all key stakeholders. + Contributes leadership input into all local study-related documentation, including study protocols. + Responsible for Clinical Operations activities conducted by the affiliate that are required by local regulations and/or usual practice to support clinical trials. + Contributes to standard operating procedure (SOP) development, implementation and training where local specifications are needed. + Ensures team’s work complies with established country practices, policies and processes, and any regulatory or other local requirements. + People Leader Path: Hires, develops and retains diverse top talent on the team. Sets clear expectations for the team and individuals direct reports. Coaches direct reports on their performance, development and career interests. May play a central role in developing other people leaders. **REQUIREMENTS:** We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role. **Minimum Education & Experience** + BA / BS / RN with 12 or more years’ relevant clinical or related experience in life sciences. Or, MA / MS / PharmD / PhD with 10 or more years’ relevant clinical or related experience in life sciences. + Typically has a minimum of 10 years’ cross-functional study management or related leadership experience in life sciences, including multiple years’ experience managing study management or project teams. + Experience developing RFPs and selection and management of CROs or other vendors. + Proven ability to successfully manage clinical studies within designated program budgets and timelines, including significant expertise in authoring clinical study and regulatory documentation and SOPs. + Meets all requirements for Associate Director (AD) grade 30 position with demonstrable proficiency. **Knowledge & Other Requirements** + Expert knowledge of various disease or therapeutic areas, as evidenced by independently applying that expertise to study management leaders and oversight for multiple clinical studies across multiple clinical programs particularly Phases (Ph 1 – 3. Mandatory Post Marketing) across the country. + Complete knowledge of full cycle study management, from start-up to close-out. + Advanced knowledge of study management best practices and tools and has shown ability to apply these to improve study efficiencies and effectiveness. + Thorough knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies. + Strong financial acumen necessary for the management of clinical trial budgets. + Proven ability to effectively author clinical study and regulatory documentation. + Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives. + Strong interpersonal skills and understanding of team dynamics. + Strong communication and organizational skills. + Strong negotiation and conflict resolution skills. + Plays a lead role in proactively managing significant change efforts as part of the complex projects managed. + As required, the ability to travel. 在吉利德，我们致力于为所有人创造一个更健康的世界。过往逾35年间，我们在HIV、病毒性肝炎、COVID-19、肿瘤等危及生命的疾病领域持续推动药物革新，改善患者生活，并在全球范围内提升药物可及。未来，我们将继续应对全球最具挑战的健康问题，为实现这一使命，需要我们同心协力、坚定信念和不懈努力。 每个你，都将在我们探索和推动改变生命的科学创新进程中扮演至关重要的角色，“吉客”是我们得以实现伟大愿景的重要伙伴，我们期待充满热忱、志存高远的你，在这里创造真正的影响力。 我们深信卓越的管理者才能赋能卓越的团队，每一位吉利德领袖都致力于为“吉客”创造积极的工作体验。无论你现在、抑或有志向成为团队管理者，都是塑造“吉客文化”的关键“引擎”，让我们共同创造一个让每位“吉客”都能感受到包容、持续成长和充分赋能的职场环境，实现未来无限可能。 加入吉利德科学，携手，突破不可能！ 示例的责任: 为国家战略和可操作的短期和长期治疗领域/职能领域计划提供输入，包括支持在实施时与其他团队成员保持一致和沟通。 为临床试验的各个方面的成功管理提供领导、指导、监督和治疗专业知识。 负责在国内指定项目的战略、运营和财务监督。 开发、实施、管理和确保在国家指定预算和时间表内完成临床试验。 通过与所有相关利益相关者的跨职能合作，为指定的临床试验/项目制定国家战略愿景。 评估、启动和管理国家合同研究组织（cro）和其他供应商，以确保指定试验/计划的成功，包括提案请求（rfp）和选择过程。 作为临床小组的一员，根据国家临床发展计划的优先级和广度，为具体项目的全球临床发展计划的国家战略实施做出贡献。 根据需要参加全球研究管理团队，并就国家要求和登记需求影响所有相关利益攸关方。 对项目现状和问题进行国家战略分析；确保实施稳健的风险缓解战略。 预见复杂的障碍并实施解决方案以实现项目目标。 解决与国家法规、准则和调查员互动有关的问题。 保持所有利益干系人适当和及时的项目状态和任何问题的建议。 与中国区总经理和其他关键的当地利益相关者合作，确保无缝执行。 通过管理临床网站合作伙伴，确保建立强大的本地网站合作伙伴关系（选择赞助伙伴）。 使用所有可用的工具跟踪，监督和沟通项目状态的所有关键利益相关者。 为所有与本地研究相关的文件提供领导意见，包括研究方案。 负责附属公司根据当地法规和/或支持临床试验的常规做法所进行的临床运营活动。 在需要当地规范的情况下，参与标准操作程序（SOP）的开发、实施和培训。 确保团队的工作符合既定的国家实践、政策和流程，以及任何法规或其他当地要求。 人才领导路径：聘用、培养和保留团队中各种顶尖人才。为团队和个人设定明确的期望。教练直接报告他们的表现，发展和职业兴趣。可能在培养其他人员领导方面发挥核心作用。 要求: 我们都是不同的，但我们都用自己独特的贡献来服务病人。请参阅以下的资格和技能，我们寻求这个角色。 最低学历和工作经验 学士/学士/注册护士，12年以上生命科学相关临床或相关经验。或硕士/硕士/药学博士/博士，10年以上生命科学相关临床或相关经验。 具有至少10年的跨职能研究管理或生命科学相关领导经验，包括多年的研究管理或项目团队管理经验。 有开发rfp和cro或其他供应商的选择和管理经验。 有能力在指定的项目预算和时间内成功地管理临床研究，包括在编写临床研究、法规文件和标准操作规程方面的专业知识。 符合30级副主任职位的所有要求，并能证明自己的能力。 知识及其他要求 具有各种疾病或治疗领域的专家知识，可独立应用该专业知识研究管理领导，并监督跨多个临床项目特别是阶段的多个临床研究（Ph 1 - 3）。强制性邮政营销)遍布全国。 具备从启动到关闭的全周期学习管理知识。 先进的学习管理最佳实践和工具的知识，并显示出应用这些提高学习效率和效果的能力。 全面了解食品药品监督管理局（FDA）和欧洲药品管理局（EMA），以及其他适用的国家法规，国际人用药物技术要求协调理事会（ICH）指南和良好临床实践（GCP）指导临床研究的实施。 良好的财务头脑是临床试验预算管理的必要条件。 具有有效撰写临床研究和法规文件的能力。 有很强的领导能力 **For Current Gilead Employees and Contractors:** Please apply via the Internal Career Opportunities portal in Workday. Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.