Assoc Director, Clinical Operations

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