Director Clinical Operations

Director, Clinical Operations- Oncology (Early Phase)
United States - Washington - SeattleUnited States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly

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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.

We empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

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. Join Gilead and help create possible, together.
Job Description

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

We are seeking a strong, experienced Director for Clinical Operations in our Oncology - Early Phase therapeutic area.

Core Responsibilities:

• Member of the Oncology Early Development Leadership Team, responsible for effective oversight of designated personnel and programs, as well as driving department goals and initiatives to desired outcomes
• Clinical operations oversight of oncology early phase programs, including tracking and managing deliverables and working cross-functionally with key stakeholders to optimize processes as related to early phase studies in efforts to streamline timelines without compromising quality data deliverables
• Strong collaboration and partnership with cross functional colleagues globally (Clinical Development, Project Management, PVE, Regulatory, Biometrics, Clinical Pharmacology, CSM, Medical Affairs, etc) to ensure on-budget, timely, high quality delivery of the programs
• Clinical operations representative on early development teams (EDT) and/or oversees direct reports serving on EDTs, ensuring clinical operations strategic and operational input to clinical development programs. Able to influence clinical development plans and is accountable for clinical operations deliverables, timelines and budgets
• Develops resource plans for programs under oversight, and oversees study teams to ensure optimal deployment and allocation of resources
• Manages people managers; recruits, hires, mentors, and manages direct reports as required and supports their professional development
• May serve as clinical operations early development representative on corporate partnerships, due diligence, and/or acquisition integration team(s), providing clinical operations input and review of partnership documents
• Initiates continuous efforts in identifying and applying best practices and enforcing standardization among teams and across programs
• Active participation and leadership in clinical operations and cross-functional organizational initiatives to drive improvements in efficiency and operational excellence
• May lead development of procedural documents within department and cross-functionally
• serves as program or TA representative for vendor oversight and governance meetings
• Travels nationally and internationally as required

Knowledge:

• Excellent verbal, written, and interpersonal skills
• Proven ability and experience to effectively execute clinical trials within designated program budgets and timelines
• Demonstrated excellence in complex project management and effectively managing multiple projects/priorities is required
• 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 financial acumen and ability to critically develop, review and track program budgets
• Ability to build and lead high-functioning teams, both within clinical operations and cross- functionally
• Thorough knowledge and understanding of FDA and EMA Regulations, ICH Guidelines, and GxPs governing the conduct of clinical trials

Required Education & Years of Experience and Skills:

• At least 12+ years of experience in clinical operations and a BS/BA or higher degree in a relevant scientific discipline. MS/MA or higher will need 10+ yrs experience in clinical operations
• Prior oncology clinical trials/operations experience in company sponsored clinical trials required with 3+ years working in Early Phase
• Line management experience. Typically has multiple years' experience managing other people leaders (with indirect reports).
• Experience on governance committees and management teams for CROs or other vendors.

Other Requirements:

• Extensive knowledge of pharma and/or biopharma industry
• Thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
• 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, Good Clinical Practice (GCP) and key Clinical Operations principles, concepts, practices, standards, processes and tools.
• Proven ability to influence up, down and across the organization and externally in a collaborative manner.
• Strong executive presence with demonstrated influence through leadership both on program teams and organizational initiatives.
• Exceptional interpersonal skills and understanding of team dynamics.
• Strong communication and organizational skills. 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.
• Advanced coaching capabilities to mentor/develop staff.
• Strong track record in effectively conceiving and leading large-scale, complex change initiatives.
• When needed, ability to travel.

The salary range for this position is: $187,000.00 - $242,000.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package . click apply for full job details