Director, Clinical Operations (United States - California - Foster City)

This job is with Gilead Sciences Inc., an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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.

Director, Clinical Operations - Oncology

We are seeking a strong, experienced Clinical Operations leader for a Director position within our Oncology Group. Clinical Operations is responsible for the worldwide execution of Phase I-IV clinical trials across all Gilead therapeutic areas and plays a key role in ensuring trials are conducted in accordance with applicable SOPs, company policies and regulatory guidelines. This work supports the timely delivery of high-quality clinical data for global registration and commercialization of Gilead's products.

You will typically lead a large team of direct and indirect reports and be accountable for the operational strategy, financial oversight and successful execution of assigned Clinical Development Plans. You will represent Clinical Operations on internal and external strategy teams, such as Global Development Teams, and will oversee the execution of complex studies, multiple studies within a program, or multiple programs. You will also manage assigned program resources, lead Clinical Operations, cross-functional and/or country or regional organizational change initiatives, and may act as a business process owner or subject matter expert for complex Clinical Operations processes. You will demonstrate an innovative mindset by championing new ideas and incorporating best practices, external benchmarking and standardization across Clinical Operations.

RESPONSIBILITIES:

• Provide Clinical Operations leadership and effective oversight of assigned Oncology personnel and programs, including tracking and managing deliverables and working cross-functionally with key stakeholders to optimize study-related processes and streamline timelines without compromising the quality of study deliverables.

• Act as the Clinical Operations representative on Global Development Teams (GDTs)/Clinical Science Teams (CSTs), providing strategic operational input into Clinical Development Plans that significantly influences the direction and outcomes of product development strategies.

• Establish and maintain strong collaboration and partnership with cross-functional colleagues globally to ensure timely, high-quality and within-budget delivery of programs. Keep stakeholders appropriately advised on project status and emerging issues.

• Proactively identify emerging risks, issues and opportunities across programs before they become critical, applying robust analytical judgement to create clarity, frame options and translate insights into practical, outcome-oriented actions.

• Demonstrate broad ownership beyond defined responsibilities by constructively challenging the status quo, taking initiative to address misalignment or emerging delivery risks, and acting with accountability for decisions, actions, and outcomes.

• Apply an end-to-end understanding of study design, patient journey, operational delivery, vendor inputs, data collection and statistical considerations to identify and mitigate risks to endpoint quality and evaluability.

• Provide effective CRO oversight by setting clear expectations, building productive partnerships that empower vendor expertise, addressing performance issues early and supporting on-time, on-budget, high-quality delivery.

• Provide 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.

• Serve as a member of the Clinical Operations Oncology Senior Leaders Forum, providing key input into the leadership and management of the Clinical Operations Oncology team and driving department goals and initiatives to desired outcomes.

• Lead and manage a team of direct and indirect reports. Hire, develop and retain diverse top talent on the team. Set clear goals for the team and individual direct reports. Coach direct reports on their performance, development and career interests. Play a lead role in developing other people leaders.

• Lead development of resource plans for assigned programs to ensure optimal deployment and allocation of resources.

• Ensure team's work complies with established practices, policies and processes, and any regulatory or other requirements.

• Initiate continuous improvement efforts, including identifying and applying best practices and driving standardization across teams and programs. 

• Play a lead role in Clinical Operations and cross-functional organizational initiatives to drive ongoing efficiencies and operational excellence.

• May also serve as the Clinical Operations representative on vendor governance committees, corporate partnerships, due diligence and/or acquisition teams, providing critical input into and review of partnership agreements and documentation.

• May lead development of standard operating procedures (SOPs) and other procedures or documentation within Clinical Operations and/or cross-functionally.

REQUIREMENTS:

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.

• Prior oncology clinical trials/operations experience in company-sponsored clinical trials

• Multiple years' experience leading high-complexity programs and/or cross-functional initiatives in clinical operations, including short- and long-range strategic planning, governance and oversight.

• Experience developing RFPs and selection and management of CROs or other vendors.

• Prior line management experience with proven effectiveness and success in hiring, managing and developing diverse top talent. Preferably multiple years' experience managing other people leaders (with indirect reports). 

• Demonstrated ability to enable on-time, on-budget and high-quality portfolio delivery from CROs through effective expectation setting, oversight and partnership.

• Demonstrated ability to build credibility and trust with senior leaders and cross-functional partners by adapting communication and influencing style to the audience and context, and by exercising sound judgement in escalation, conflict resolution and stakeholder engagement.

Knowledge & Other Requirements

• Extensive experience in the delivery of registration-intent oncology clinical trial programs including understanding of oncology endpoints and approaches to ensure endpoint integrity.

• Thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials, including knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), 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.

• Proven ability and experience to effectively execute clinical trials within designated program budgets and timelines. Strong financial acumen necessary for the development and management of clinical trial budgets.

• Critical and creative thinker with demonstrated ability to operate effectively and independently in ambiguous and changing environments, balancing timely decision-making with appropriate evidence, reflection and stakeholder input.

• Strong leadership presence and stakeholder management skills, with demonstrated ability to build credibility and trust with senior leaders and cross-functional partners, adapt communication and influencing style to the audience and context, lead without authority, resolve conflict constructively, and exercise sound judgement in escalation and stakeholder engagement.

• Strong interpersonal skills and understanding of team dynamics.

• Demonstrable abilities to effectively communicate project direction and status to varying organiz]]>