Gilead Sciences - Foster City, CA

posted 4 days ago

Full-time - Mid Level
Foster City, CA
Chemical Manufacturing

About the position

The Senior Manager, Business Strategy & Operations at Gilead Sciences plays a crucial role in the Clinical Trial Capabilities (CTC) organization, focusing on driving strategic and operational improvements within Clinical Operations. This position involves managing multiple projects, serving as a project manager for complex initiatives, and ensuring the successful implementation of processes that enhance clinical trial execution in a highly regulated environment.

Responsibilities

  • Serve as Project Manager for assigned initiatives/projects and working groups, ensuring progression to achieve timelines.
  • Act as execution implementation lead to ensure completed initiatives are adopted and embedded as ClinOps ways of working.
  • Allocate to new/existing ClinOps and non-ClinOps led workstreams/initiatives to provide input and drive key processes from a ClinOps perspective.
  • Report on study CRO/Vendor sourcing strategy and headcount resourcing.
  • Review and recommend changes to Clinical Operations process management/improvement and associated procedural documentation in collaboration with business process owners and stakeholders.
  • Provide direction to study teams and stakeholders on initiative recommendations in collaboration with other CTC sub-functions.
  • Drive standardization and the adoption of best practices across the Clinical Operations organization.

Requirements

  • 6+ years of relevant experience in Clinical Operations/project management or process improvement with a Bachelor's degree.
  • 4+ years of relevant experience in Clinical Operations/project management or process improvement with a Master's degree.
  • Thorough knowledge of FDA, EMA, and other applicable national regulations, such as ICH guidelines and GCP.
  • Strong interpersonal and negotiation skills.
  • Ability to analyze problems and logically structure problem-solving strategies.

Nice-to-haves

  • Experience working with one or more therapeutic areas and managing clinical trials in varying stages of drug development.
  • Familiarity with project/process improvement methodologies such as Lean Six Sigma.

Benefits

  • Company-sponsored medical, dental, vision, and life insurance plans.
  • Discretionary annual bonus.
  • Discretionary stock-based long-term incentives.
  • Paid time off.
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