Clinical Contracts

2 weeks ago

Foster City, United States Gilead Sciences Full time

Responsibilities:

  • Excellent employment opportunity for a Mgr, Clinical Contracts & Finance Can be based in either Foster City, CA or NJ locations.
  • This is an onsite position 5 days a week.
  • Currently seeking an industry leader for Sr. Manager, R&D Outsourcing within our Development Business Operations department.
  • The Sr. Manager will have the opportunity to provide category management, sourcing and contracting expertise in clinical outsourcing of global Phase 1b-Phase 3 clinical trials.
  • The Sr. Manager will lead the entire life cycle including vendor selection, RFI, RFP, vendor selection decision, contracting, monitoring performance, change orders and ensuring proper closeout of clinical agreements, with a focus on Clinical Research Organizations (CRO).
  • The position will have the opportunity to work in a matrix environment and regularly collaborate with Senior Management and cross functional teams.
  • Develops global clinical development vendor strategy for a program or therapeutic area with a focus on Cell Therapy
  • Manages contract and sourcing activities for Phase 1b-3 clinical development programs providing consistent customer service and delivering quantitative value through cost savings and transformation/innovation.
  • Develops and implements sourcing strategies to support given scope.
  • Manages the contract negotiation process across the entire life cycle including RFI, vendor identification, RFP, vendor selection decision, contracting negotiation, performance monitoring, change orders, and ensures proper closeout of agreements to maximize contract value and achieve target savings.
  • Ensure the vendor selection process is compliant by managing risks through benchmarking, rate negotiations, implementing the sourcing strategy, collaborating with cross functional teams such as Compliance, Legal and Regulatory
  • Collaborates with internal customers in vendor bidding and proposal development (RFP creation and analysis)
  • Partners with internal customers to develop study specifications and leverages benchmarking tools as appropriate.
  • Translates business requirements into vendor capabilities and develops recommendations for vendor selection for a program or therapeutic area.
  • Is an SME in resolving complex issues relating to contract negotiation and management
  • Oversees the identification, selection and management of global external service providers.
  • Leads Vendor bid defense meetings.
  • Manages the contract negotiation process for complex or high value contracts.
  • Demonstrates strong understanding of regulatory and legal issues pertinent to clinical development.
  • Ability to understand, analyze and develop recommendations from multiple complex sources such as financial and operational perspectives.
  • Influence vendor selection with stakeholders at the project team level
  • Translates trends in operational and systematic issues and develops solutions with sustainability in mind to ensure roadblocks are removed during study start-up
  • Resolves vendor project management issues (e.g., operational challenges including scoping issues) by identifying and addressing deviations from established protocols
  • As necessary, trains internal stakeholders in contract budgeting, development, and administration

Experience:

  • Relevant experience with a BA or MS in a relevant discipline
  • MBA or JD preferred
  • PMP/CPSM certification or equivalent a plus
  • Experience in providing thought leadership and consistent customer service
  • Expertise in the end-to-end sourcing and contracting process, including RFx, contract negotiation and management
  • Demonstrates an in-depth knowledge of the clinical research process and the regulatory environment across functions
  • Demonstrated leadership skills while working in fast paced and changing environment
  • Financial acumen to review, analyze and understand cost drivers of complex budgets
  • Legal, clinical operations and regulatory acumen
  • Travel may be required

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