MGR, CLINICAL CONTRACTS
3 weeks ago
100% Onsite
Candidate can be based in either Foster City, CA or Parsippany-Troy Hills, NJ or Santa Monica, CA locations
Job Description:
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.
The core responsibilities and skills required for this position include but is not limited to:
Delivery Excellence
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
Strategic Thinking
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
Innovation
Identifies, develops, and deploys best practices in vendor selection, cost containment, and category management practices
Leverages prior experience with external benchmarking, industry best practices, and technology for continuous improvement
Problem Solving
Takes ownership of issues from problem identification to successful resolution, testing recommendations for reasonableness
Triages study-level vendor management issues; escalates high-risk issues to appropriate stakeholders
Translates trends in operational and systematic issues and develops solutions with sustainability in mind to ensure roadblocks are removed during study start-up
Influence and Partnership
Engage with clinical operations leadership to drive sourcing strategy, compliance, and continued partnership
Exhibits competency in regularly establishing relationships with internal and external cross functional teams, such as clinical operations, legal, finance, compliance
Partners with internal stakeholders working on contracts in resolving complex issues relating to contract negotiation or management
Manages study level vendor relationships in conjunction with Clinical Operations
Decision Making
Delivers value by developing business solutions by translating requirements into effective sourcing solutions, contractual terms and process improvements
Demonstrated ability to make critical decisions related to clinical vendor agreement negotiations and escalations
Pulls data across functions according to business requirements and recommends global development vendors to senior leadership for endorsement for a project
Asks probing questions to uncover business needs and recommends solutions (e.g., negotiating timelines while maintaining standards)
Resolves vendor project management issues (e.g., operational challenges including scoping issues) by identifying and addressing deviations from established protocols
Identifies operational and systematic issues, including frequency and escalates to the appropriate level
Communication
Excellent communication skills and comfort level interacting with internal and external teams across all levels, including regular interface with stakeholders and leadership team members
As necessary, trains internal stakeholders in contract budgeting, development, and administration
Capabilities and Requirements
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
Knowledge, Experience and Skills:
Relevant experience with a BA or MS in a relevant discipline
MBA or JD preferred
PMP/CPSM certification or equivalent a plus
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