Clinical Contracts Manager
3 weeks ago
Candidate can be based in either Foster City, CA or NJ or Santa Monica locations
Core Responsibilities:
Delivery Excellence:
- Develop a comprehensive global clinical development vendor strategy for Cell Therapy programs or therapeutic areas.
- Lead contract and sourcing activities for Phase 1b-3 clinical development programs, ensuring consistent customer service and delivering quantitative value through cost savings and innovation.
- Implement sourcing strategies and oversee the entire contract negotiation process to maximize contract value and achieve target savings.
- Ensure compliance in the vendor selection process, collaborating with cross-functional teams such as Compliance, Legal, and Regulatory.
- Collaborate with internal stakeholders in vendor bidding, proposal development, and study specification development.
- Serve as a subject matter expert in resolving complex issues related to contract negotiation and management.
- Manage the identification, selection, and management of global external service providers.
- Lead vendor bid defense meetings and manage contract negotiation process for complex or high-value contracts.
- Demonstrate a strong understanding of regulatory and legal issues pertinent to clinical development.
Strategic Thinking:
- Analyze multiple complex sources to develop recommendations from financial and operational perspectives.
- Influence vendor selection with stakeholders at the project team level.
Innovation:
- Identify, develop, and deploy best practices in vendor selection, cost containment, and category management practices.
- Utilize prior experience with external benchmarking, industry best practices, and technology for continuous improvement.
Problem Solving:
- Take ownership of issues from problem identification to successful resolution, triaging study-level vendor management issues and escalating high-risk issues.
- Develop sustainable solutions to operational and systematic issues to ensure study start-up proceeds smoothly.
Influence and Partnership:
- Engage with clinical operations leadership to drive sourcing strategy, compliance, and partnership.
- Establish relationships with internal and external cross-functional teams, collaborating with clinical operations, legal, finance, and compliance.
- Manage study-level vendor relationships in conjunction with Clinical Operations.
Decision Making:
- Develop business solutions by translating requirements into effective sourcing solutions, contractual terms, and process improvements.
- Make critical decisions related to clinical vendor agreement negotiations and escalations.
- Recommend global development vendors to senior leadership for endorsement for a project.
- Resolve vendor project management issues and escalate as needed.
Communication:
- Demonstrate excellent communication skills, interacting with internal and external teams across all levels.
- Train internal stakeholders in contract budgeting, development, and administration as necessary.
Capabilities and Requirements:
- Experience providing thought leadership and consistent customer service.
- Expertise in the end-to-end sourcing and contracting process, including RFx, contract negotiation, and management.
- In-depth knowledge of the clinical research process and regulatory environment across functions.
- Demonstrated leadership skills in a 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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