Vice President, Clinical Operations Inflammation

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 fulfill their aspirations. Join Gilead and help create possible, together.

Job Description

Vice President, Clinical Operations is responsible for the leadership, strategic planning, oversight, and execution of clinical trials and projects in the Inflammation Therapeutic Area.

Core Responsibilities:

• Delivery Excellence: Oversees and leads the Inflammation clinical operations team to ensure operational trial deliverables across programs are completed according to timelines, budget, operational procedures, quality standards, SOPs and business guidelines; Directly participates in and has accountability for overall clinical operations strategy, clinical trial delivery model and performance against key trial metrics and deliverables; Ensures compliance with SOPs, ICH-GCP guidelines, regulatory authority regulations and patient safety standards in the conduct of clinical trial execution; Ensures inspection readiness of both active and completed studies and programs

• Innovation: Continually seeks opportunities to make Clinical Operations more patient-centric and solidify Gilead as the partner of choice for investigators and sites; Evaluates and understands the evolving Oncology landscape of innovative development capabilities/approaches; incorporates new capabilities/approaches into Clinical Operations toolkit as necessary and drives their adoption within the organization

• Influence and Partnership: Provides executive oversight and develops relationships with CRO and vendor partners; Establishes vendor metrics and conducts review in support of quality delivery (in partnership with Business Operations); Works closely with cross-functional Development organization leadership including Therapeutic Area leaders, Medical Affairs, Regulatory / Quality, Pharmacovigilance and Biometrics

Additional Responsibilities:

• Strategic Thinking: Sets overall direction, strategy and performance standards for clinical operations staff to assure that project objectives are achieved; Creates a resourcing strategy to support needs for Inflammation clinical programs and activities

• People Development: Develops others by identifying and mentoring high performers and building a culture of inclusion and collaboration throughout the organization; Delegates responsibility and empowers others; Ensures clinical operations staff are qualified, competent, and trained in applicable regulations, guidance and Gilead standards

• Decision-making: Assesses portfolio and organizational needs and builds a scalable and flexible Clinical Operations infrastructure to support the future vision; Identifies areas of opportunity for the clinical operations organization and determines path forward, Implements corrective action with consultation of senior Development leaders

• Communication: Advocates on behalf of Gilead and effectively communicates complex medical/clinical concepts in both written and oral communication to both internal and external stakeholders

Capabilities and Requirements:

• You have the ability to create and fulfill a vision for Inflammation Clinical Operations in a matrix environment and work collaboratively with internal stakeholders across different functions

• You have the credibility and reputation to attract and retain clinical operations experts, with a history of creating teams that can thrive in a fast-paced, matrixed environment

• You have excellent oral and written communication skills, including the ability to translate between business leaders, scientists and technologists

• You have a track record of successfully leading a clinical operations Inflammation organization including meeting timeline, budget, and resourcing requirements

• You have practical experience in identifying, vetting and managing CRO partnerships

Education and Qualifications:

• Bachelor's degree in a scientific discipline, advanced or professional degree desirable

• 10+ years of experience and a consistent track record in clinical drug development with complex clinical studies including leading global trials in an outsourced CRO partnership model

• Experience in successful planning and implementation of clinical trial operations on time, within budget, and in compliance for strategies, plans and study execution from early through late stage

• Understanding of applicable clinical research regulations in multiple regions

Gilead Core Values

• Integrity (Doing What’s Right)

• Inclusion (Encouraging Diversity)

• Teamwork (Working Together)

• Excellence (Being Your Best)

• Accountability (Taking Personal Responsibility)