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Gilead Sciences

Makes medicines for HIV, liver disease and cancer

Vice President, Clinical Operations - Inflammation

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeFoster City, CA, USANo salary listed

About the Job

Requirements

  • Ability to create and fulfill a vision for Inflammation Clinical Operations in a matrix environment and work collaboratively with internal stakeholders across different functions.
  • 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.
  • 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, including meeting timeline, budget, and resourcing requirements.
  • Practical experience identifying, vetting, and managing contract research organization partnerships.
  • Bachelor's degree in a scientific discipline; an advanced or professional degree is 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 contract research organization 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.

Responsibilities

  • Lead and oversee the Inflammation clinical operations team to ensure operational trial deliverables across programs are completed according to timelines, budget, operational procedures, quality standards, standard operating procedures, and business guidelines.
  • Participate directly in and be accountable for overall clinical operations strategy, clinical trial delivery model, and performance against key trial metrics and deliverables.
  • Ensure compliance with standard operating procedures, International Council for Harmonisation Good Clinical Practice guidelines, regulatory authority regulations, and patient safety standards in clinical trial execution.
  • Ensure inspection readiness of active and completed studies and programs.
  • Identify opportunities to make Clinical Operations more patient-centric and strengthen Gilead as a partner of choice for investigators and sites.
  • Evaluate the evolving Oncology landscape of innovative development capabilities and approaches, incorporate new approaches into the Clinical Operations toolkit as needed, and drive their adoption within the organization.
  • Provide executive oversight of and develop relationships with contract research organization and vendor partners.
  • Establish vendor metrics and conduct reviews in support of quality delivery in partnership with Business Operations.
  • Work closely with cross-functional Development organization leadership, including Therapeutic Area leaders, Medical Affairs, Regulatory and Quality, Pharmacovigilance, and Biometrics.
  • Set overall direction, strategy, and performance standards for clinical operations staff to ensure project objectives are achieved.
  • Create a resourcing strategy to support Inflammation clinical program and activity needs.
  • Identify and mentor high performers, build a culture of 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 a scalable, flexible Clinical Operations infrastructure to support the future vision.
  • Identify opportunities for the clinical operations organization and determine a path forward; implement corrective action in consultation with senior Development leaders.
  • Advocate on behalf of Gilead and communicate complex medical and clinical concepts effectively in writing and orally to internal and external stakeholders.
  • Model inclusive leadership and embed diversity, equity, and inclusion into how the team operates, makes decisions, and develops talent.
  • Understand employees' skills, aspirations, and potential; provide coaching, feedback, and opportunities that grow current performance and future readiness.
  • Align team goals to enterprise and R&D priorities, clarify decision rights, remove barriers, and connect the team to the broader Public Affairs and R&D ecosystem.

Desired Qualifications

  • An advanced or professional degree.

About the Company

Gilead Sciences

Makes medicines for HIV, liver disease and cancer

Gilead Sciences is a biopharmaceutical company that discovers, develops and sells medicines for HIV, viral hepatitis and other liver diseases, cancer and inflammatory conditions. Its HIV business covers both treatment, led by the once-daily pill Biktarvy, and prevention, including Descovy and Yeztugo, a lenacapavir injection given twice a year. In cancer, its Kite unit makes CAR T-cell therapies from patients' own immune cells, and Trodelvy is an antibody-drug conjugate for breast cancer. Gilead earns revenue by selling its drugs to wholesalers, specialty pharmacies, hospitals and governments worldwide after regulatory approval. The company was founded in 1987 and is headquartered in Foster City, California.

Company size
10,001+
Company stage
IPO
Headquarters
Foster City, CA
Founded
1987

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