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
 

 (Associate) Director, Clinical Operations

Job Family

Clin Ops Mgmt

Job Description

RESPONSIBILITIES:

• • Leads and manages a team of direct and indirect reports. Hires, develops and retains diverse top talent on the team. Sets clear goals for the team and individual direct reports. Coaches direct reports on their performance, development and career interests. Plays a lead role in developing other people leaders.
  • Provides input into 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.
  • May sit on the Clinical Operations TA Leadership Team; providing key input into the leadership and management of the Clinical Operations TA Team.
  • Provides Clinical Operations leadership oversight of assigned TA programs, including tracking and managing deliverables and working cross-functionally with key stakeholders to optimize processes related to studies and in an effort to streamline timelines without compromise to quality study deliverables.
  • Establishes and maintains a strong collaboration and partnership with cross-functional colleagues globally to ensure timely, high-quality and within-budget delivery of programs.
  • Acts as the Clinical Operations representative on GDTs and/or oversees direct reports serving on GDTs; ensuring Clinical Operations strategic and operational input into Clinical Development programs.
  • Provides strategic input into Clinical Development Plans that significantly influences the direction and outcomes of product development strategies.
  • May also serve as the Clinical Operations representative on corporate partnerships, due diligence and/or acquisition teams; providing critical input into and review of partnership agreements and documentation.
  • Leads development of all resource plans for all assigned programs to ensure optimal deployment and allocation of resources.
  • Initiates continuous improvement efforts, including identifying and applying best practices and driving standardization across teams and programs.
  • Compiles, assesses and communicates risks and options to support program goal achievement and informed decision-making.
  • Plays a lead role in Clinical Operations and cross-functional organizational initiatives to drive ongoing efficiencies and operational excellence.
  • Solves problems relating to national and international regulations, guidelines and investigator interactions.
  • Keeps all stakeholders appropriately and timeously advised on all aspects of project status and any issues.
  • Uses all available tools to track, oversee and communicate on program status to all key stakeholders.
  • Contributes leadership input into all study-related documentation, including study protocols.
  • May lead development of standard operating procedures (SOPs) and other procedures or documentation within Clinical Operations and/or cross-functionally.
  • Responsible for Clinical Operations activities conducted by the affiliate that are required by local regulations and/or usual practice to support clinical trials.
  • Ensures team’s work complies with established practices, policies and processes, and any regulatory or other requirements.

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.
  • Multiple years’ experience leading or co-leading high-complexity cross-functional initiatives in life sciences, including short- and long-range strategic planning, governance and oversight.
  • Experienced on post market trials or real world data/evidence trials.
  • Experience developing RFPs and selection and management of CROs or other vendors.
  • Typically has significant line management experience with proven effectiveness and success in hiring, managing and developing diverse top talent.
  • Demonstrated excellence in complex project management and effectively managing multiple projects and priorities.
  • Experience communicating with and presenting to executives and managing large-scale budgets and other resources.
  • Meets all requirements for Associate Director, Clinical Operations grade 30 position with demonstrable proficiency.

Knowledge & Other Requirements

• • Expert knowledge of the biopharma industry, as evidenced by proven track record in setting short- and long-range business strategies and plans.
  • Thorough knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies.
  • Thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
  • Strong financial acumen necessary for the management of clinical trial budgets.
  • 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. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees.
  • Strong negotiation and conflict resolution skills.
  • Strong coaching capabilities to mentor/develop staff.
  • Demonstrated effectiveness in proactively managing change.
  • When needed, 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！

岗位职责： 

• • 直接或间接的管理团队，为团队招聘、发展和保留各种顶尖人才。为团队和下属制定明确的目标。为他们的表现，发展和职业兴趣进行指导和建议。在培养其他人的领导能力方面发挥重要作用。 
  • 为临床战略和可实现的短期、长期治疗领域计划提供适当的建议，包括在执行过程中提供校准和有效的沟通。 
  • 如有需要，作为临床运营领导者，为临床运营团队的领导和管理提供建议。 
  • 对项目进行临床运营的领导监督，包括跟踪和管理交付成果，与关键利益相关者进行跨职能合作，优化与实验相关的流程，在不影响高质量实验交付成果的前提下精简时间线。 
  • 与全球跨部门同事建立并保持强有力的合作和伙伴关系，以确保及时、高质量和在预算内交付项目。 
  • 作为GDT的临床运营代表或监督人，确保对临床开发项目的战略和操作投入。 
  • 为临床开发计划提供战略建议，提高优化产品开发战略的方向和结果。 
  • 担任临床运营负责人，负责企业合作、尽职调查和收购团队，对合作协议和文件提供关键意见和审查。 
  • 领导制定所有项目的资源计划，确保资源的最佳部署和分配。 
  • 持续优化工作流程，包括识别和应用最佳实践，推动团队和项目之间的标准化。 
  • 制定、评估和沟通潜在风险，以支持项目目标的实现和更明智的决策。 
  • 在临床运营和跨职能组织活动中发挥领导作用，以推动更高效和卓越的工作方式。 
  • 解决与国内和国际法规、指南和调查人员互动有关的问题。 
  • 及时向所有相关人员提供项目状态和任何问题的相关建议。 
  • 使用所有可用工具跟踪、监督项目状态，并与所有关键利益相关者保持沟通。 
  • 为所有与研究相关的文档提供领导意见，包括研究协议。 
  • 根据当地法规或惯例要求，指导下属机构开展的临床运营活动，以支持临床试验。 
  • 发起、撰写或协助标准操作程序的开发、实施和培训。 
  • 确保团队的工作符合既定的实践、政策和流程，以及任何法规或其他要求。 

教育背景和经验要求： 

• • 本科及以上学历，拥有12年以上生命科学相关临床或相关经验，或硕士及以上学历，拥有10年以上生命科学相关临床或相关经验。 
  • 丰富的生命科学领域复杂性跨部门合作项目经验，包括短期和长期战略规划、管理和监督经验。 
  • 有上市后临床试验或者真实世界数据试验的经验。
  • 拥有开发RFPs，选择和管理CRO或其他供应商的经验。 
  • 拥有丰富的部门管理经验，在招聘、管理和培养多样化的顶级人才有成功的案例。 
  • 拥有出色的复杂项目管理经验者优先。 
  • 拥有与高管沟通、汇报，管理大规模预算和其他资源的经验。 

知识和其他要求： 

• • 具备生物制药行业的专业知识，在制定短期和长期商业战略和计划方面有良好的经验。拥有实践和管理临床研究项目的良好知识，并有能力应用这些来提高研究效率和效果。 
  • 全面了解食品、药物管理局(FDA)和欧洲药品管理局(EMA)，以及其他适用的国家法规（包括ICH要求和临床实践经验）。 
  • 全面了解药品监管要求以及对临床实验开发和执行的影响。 
  • 对临床试验预算的管理具有良好的财务敏感度。 
  • 优秀的团队领导能力 
  • 优秀的人际交往能力和对团队动态的理解。 
  • 优秀的沟通和组织能力，能有效的向不同组织层级的同事传达项目方向和状态。 
  • 优秀的谈判和解决冲突能力。 
  • 优秀的管理和培养各类顶级人才的能力。 
  • 高效、灵活的团队管理能力。 
  • 如有需要，能够接受一定程度出差。 

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.