Director, Clinical Operations

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

We are seeking a strong, experienced Clinical Operations leader for a Director position within our Oncology Lung and Gastrointestinal (GI) Franchise. Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead’s products.

You will typically lead a large team of direct and indirect reports. You will be accountable for the operational strategy and successful execution of the Clinical Development Plan, including financial accountability. You will actively represent Clinical Operations on internal and external strategy teams, e.g., Global Development Teams. You will be accountable for the resource management of assigned programs, including ongoing assessment of resource needs and optimal deployment of resources to support a fluid ‘One Ops’ workforce. You will lead and/or effectively engage in Clinical Operations, cross-functional and/or country or regional organizational change initiatives and strategy. You will oversee and be responsible for the successful execution of more complex studies and/or multiple studies within a program or multiple programs. You may act as the business process owner (BPO) and/or serve as a subject matter expert for complex Clinical Operations processes. You will demonstrate an innovative mindset by championing new ideas and initiatives and incorporating best practices, external benchmarking and standardization across Clinical Operations.

RESPONSIBILITIES:

Provides 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 processes related to studies and in an effort to streamline timelines without compromise to quality study deliverables.

Acts as the Clinical Operations representative on Global Development Teams (GDTs); Provides strategic input into Clinical Development Plans that significantly influences the direction and outcomes of product development strategies.

Establishes and maintains a strong collaboration and partnership with cross-functional colleagues globally to ensure timely, high-quality and within-budget delivery of programs. Keeps all stakeholders appropriately and timeously advised on all aspects of project status and any issues.

Compiles, assesses and communicates risks and options to support program goal achievement and informed decision-making. 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.

Member of the Clinical Operations Oncology Lung/GI Franchise Leadership Team; providing key input into the leadership and management of the Clinical Operations Oncology Team, as well as driving department goals and initiatives to desired outcomes.

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.

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.

Leads development of all resource plans for all assigned programs to ensure optimal deployment and allocation of resources.

Ensures team’s work complies with established practices, policies and processes, and any regulatory or other requirements.

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

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.

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 or, MA / MS / PharmD / PhD with solid 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 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.

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 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 management of clinical trial budgets.

Demonstrated excellence in complex project management and effectively managing multiple projects/priorities

Critical and creative thinker; able to work independently to determine appropriate resources for resolution of complex problems

Compiles, assesses and communicates risks and optionality to support informed decision making for operational strategy

Effectively utilizes tools (reports, dashboards) to track and oversee programs, and communicate appropriately to key stakeholders

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.

Able to distill complex matters into a clear business case and roadmap for execution.

Demonstrated ability to align other leaders and garner their commitment and engagement to cross-functional strategies, plans and strategic objectives.

Strong negotiation and conflict resolution skills.

Strong coaching capabilities to mentor/develop staff

Demonstrated effectiveness in proactively managing change.

Strong track record in effectively conceiving and leading large-scale, complex change initiatives.

When needed, ability to travel.

For jobs in the United States:

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