Gilead Sciences - San Mateo, CA

posted 4 months ago

Full-time - Mid Level
San Mateo, CA
Chemical Manufacturing

About the position

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. The Clinical Trial Capabilities (CTC) organization offers infrastructure, support, and solutions enabling the Clinical Operations and Development Organizations with rapid, efficient, and compliant clinical trial execution to deliver transformative medicines to patients. The Business Strategy & Operations team within the CTC organization is responsible for driving strategic and operational process improvements and/or implementation of processes for Clinical Operations. The Sr. Manager, Business Strategy & Operations role supports and manages new workstreams and initiatives for the Clinical Operations organization within a fast-paced and highly regulated environment. In addition, they will have multi-project responsibilities and serve as a project manager as needed on complex initiatives and working groups.

Responsibilities

  • Serving as Project Manager, drives assigned initiatives/projects and working groups ensuring progression to achieve timelines
  • Working as an execution implementation lead, ensure completed initiatives are adopted and embedded as ClinOps ways of working
  • Allocation to new/existing ClinOps and non-ClinOps led workstream/initiative to provide input and drive key processes from a ClinOps perspective
  • Reporting on study CRO/Vendor sourcing strategy and headcount resourcing
  • Reviews and recommends changes to Clinical Operations process management/improvement and associated procedural documentation in collaboration with business process owners, cross-functional stakeholders, and subject matter experts
  • In collaboration with other CTC sub-functions, provides direction to study teams, business process owners, cross-functional stakeholders, and subject matter experts on initiative recommendations
  • Drives standardization and the adoption of best practices across the Clinical Operations organization

Requirements

  • 6+ years of relevant experience (project management, process improvement) with Bachelor's degree
  • 4+ years of relevant experience (project management, process improvement) with Master's degree
  • Experience working with one or more therapeutic areas and varying stages of drug development is a plus
  • Thorough knowledge of FDA, EMA, and other applicable national regulations, such as ICH guidelines and GCP
  • Strong interpersonal and negotiation skills
  • Strong change champion with a good understanding of change management strategies
  • Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives
  • Demonstrate strategic enterprise thinking to find innovative ways to increase process efficiency

Nice-to-haves

  • Implement project/process improvement methodologies such as Lean Six Sigma to drive continuous improvement across the organization

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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