Vice President, Clinical Operations Inflammation

Gilead Sciences•Foster City, CA

About The Position

The Vice President, Clinical Operations leads strategic planning, oversight, and execution of clinical trials and projects in the Inflammation Therapeutic Area. The role oversees clinical operations teams and trial delivery across programs, ensuring work meets timelines, budgets, operational procedures, quality standards, SOPs, and business guidelines. It is accountable for clinical operations strategy, the trial delivery model, performance against key metrics, regulatory compliance, patient safety, and inspection readiness for active and completed studies. The Vice President advances patient-centric operations and evaluates evolving development capabilities and approaches for potential adoption. The role provides executive oversight of CRO and vendor partnerships, establishes and reviews vendor metrics with Business Operations, and works closely with cross-functional Development leaders, including Therapeutic Area leaders, Medical Affairs, Regulatory and Quality, Pharmacovigilance, and Biometrics. The position sets direction, strategy, performance standards, and resourcing plans for the clinical operations organization. It builds scalable infrastructure, identifies improvement opportunities, and implements corrective actions in consultation with senior Development leaders. It also develops and mentors talent, fosters inclusion and collaboration, ensures staff are qualified and trained, and communicates complex medical and clinical concepts to internal and external stakeholders.

Requirements

  • Bachelor's degree in a scientific discipline.
  • At least 10 years of experience and a consistent track record in clinical drug development, including complex clinical studies and leadership of global trials using outsourced CRO partnerships.
  • 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.
  • Demonstrated ability to create and fulfill a vision for Inflammation Clinical Operations in a matrix environment and collaborate across functions.
  • Credibility and reputation for attracting and retaining clinical operations experts, with a history of building teams that thrive in fast-paced, matrixed environments.
  • Excellent oral and written communication skills, including the ability to translate between business leaders, scientists, and technologists.
  • Track record of successfully leading an Inflammation clinical operations 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 ensure trial deliverables meet timelines, budgets, procedures, quality standards, SOPs, and business guidelines.
  • Set clinical operations strategy and the clinical trial delivery model, and oversee performance against trial metrics and deliverables.
  • Ensure compliance with SOPs, ICH-GCP guidelines, regulatory requirements, and patient safety standards; maintain inspection readiness for active and completed studies and programs.
  • Identify opportunities to make Clinical Operations more patient-centric and evaluate and adopt innovative development capabilities and approaches.
  • Provide executive oversight of CRO and vendor partners; establish vendor metrics and review performance with Business Operations.
  • Partner with cross-functional Development leaders, including Therapeutic Area leaders, Medical Affairs, Regulatory and Quality, Pharmacovigilance, and Biometrics.
  • Set overall direction, strategy, and performance standards for clinical operations staff and develop resourcing strategies for Inflammation programs and activities.
  • Mentor high performers, foster inclusion and collaboration, delegate responsibility, empower staff, and ensure staff qualifications and training.
  • Assess portfolio and organizational needs and build scalable, flexible Clinical Operations infrastructure for future needs.
  • Identify organizational opportunities, determine a path forward, and implement corrective actions in consultation with senior Development leaders.
  • Advocate on behalf of Gilead and communicate complex medical and clinical concepts effectively to internal and external stakeholders.
  • Model inclusive leadership, develop talent through coaching and feedback, align team goals to enterprise and R&D priorities, clarify decision rights, and remove barriers.
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