Vice President, Clinical Operations Inflammation

Gilead Sciences•Foster City, CA

About The Position

The Vice President, Clinical Operations leads the strategic planning, oversight, and execution of clinical trials and projects in the Inflammation Therapeutic Area. The role is accountable for clinical operations strategy, trial delivery models, performance against key metrics, and delivery of operational commitments according to timelines, budgets, procedures, quality standards, and business guidelines. It also ensures compliance with SOPs, ICH-GCP guidelines, regulatory requirements, and patient-safety standards, as well as inspection readiness for active and completed studies and programs. The Vice President advances patient-centric clinical operations, evaluates innovative development capabilities and approaches, and drives their adoption where appropriate. The role provides executive oversight of CRO and vendor relationships, establishes and reviews vendor metrics in partnership with Business Operations, and collaborates with leaders across Development, including Therapeutic Area leadership, Medical Affairs, Regulatory/Quality, Pharmacovigilance, and Biometrics. The position sets direction and performance standards for clinical operations staff, establishes resourcing strategies, builds scalable and flexible operational infrastructure, and develops a collaborative and inclusive organization. It mentors high performers, delegates and empowers others, and ensures staff are qualified and trained. The role also communicates complex clinical concepts to internal and external stakeholders and represents Gilead in support of its clinical operations.

Requirements

Bachelor's degree in a scientific discipline.
At least 10 years of experience and a consistent track record in clinical drug development with complex clinical studies, including leadership of global trials in an outsourced CRO partnership model.
Experience successfully planning and implementing clinical trial operations on time, within budget, and in compliance, from early- through late-stage development.
Understanding of applicable clinical research regulations in multiple regions.
Ability to create and fulfill a vision for Inflammation Clinical Operations in a matrix environment and collaborate with internal stakeholders across functions.
Credibility and reputation to attract and retain clinical operations experts, with a history of building teams that thrive in a fast-paced, matrixed environment.
Excellent oral and written communication skills, including the ability to translate between business leaders, scientists, and technologists.
Track record of successfully leading a clinical operations Inflammation organization while meeting timeline, budget, and resourcing requirements.
Practical experience identifying, vetting, and managing CRO partnerships.

Nice To Haves

Advanced or professional degree.

Responsibilities

Lead the Inflammation clinical operations team and oversee operational trial deliverables across programs to meet timelines, budgets, procedures, quality standards, SOPs, and business guidelines.
Set and be accountable for clinical operations strategy, the clinical trial delivery model, and performance against key trial metrics and deliverables.
Ensure clinical trial execution complies with SOPs, ICH-GCP guidelines, regulatory requirements, and patient-safety standards.
Ensure inspection readiness for active and completed studies and programs.
Identify opportunities to make Clinical Operations more patient-centric and strengthen Gilead's position as a partner of choice for investigators and sites.
Evaluate innovative development capabilities and approaches and incorporate and drive adoption of relevant approaches within Clinical Operations.
Provide executive oversight of CRO and vendor partners; establish vendor metrics and review delivery quality in partnership with Business Operations.
Collaborate with Development leaders and cross-functional partners, including Therapeutic Area leaders, Medical Affairs, Regulatory/Quality, Pharmacovigilance, and Biometrics.
Set direction, strategy, and performance standards for clinical operations staff and create resourcing strategies for Inflammation programs and activities.
Mentor high performers, develop staff, and foster inclusion and collaboration; delegate responsibility and empower others.
Ensure clinical operations staff are qualified, competent, and trained in applicable regulations, guidance, and Gilead standards.
Assess portfolio and organizational needs and build scalable, flexible Clinical Operations infrastructure to support future needs.
Identify organizational opportunities, determine paths forward, and implement corrective actions in consultation with senior Development leaders.
Communicate complex medical and clinical concepts effectively to internal and external stakeholders.