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About the role
Key responsibilities & impact- Own and continuously refine BBOT’s clinical outsourcing strategy
- Lead CRO and vendor selection for clinical programs, including RFPs, RFIs, vendor evaluations, and bid defense meetings
- Establish and maintain preferred provider relationships with pre-negotiated pricing frameworks
- Identify outsourcing needs early and ensure vendors are selected and onboarded ahead of program timelines
- Negotiate CRO and vendor contracts, work orders, change orders, master service agreements, and clinical budgets
- Manage the full contract lifecycle from scope development and proposal review through amendments, change orders, close-out, and financial reconciliation
- Evaluate vendor proposals and budgets against industry benchmarks and identify risks and pricing gaps
- Partner with Legal on compliant vendor agreements and coordinate PVAs, confidentiality agreements, and quality agreements
- Track contract timelines, expiry dates, and renewals
- Own monthly and quarterly financial reviews, accruals, purchase order management, and budget tracking
- Review and approve vendor invoices against contracts, work orders, and deliverables
- Maintain budget forecasts and report spend status, variances, and risks to program teams, Finance, and senior leadership
- Support clinical trial budget development with cost estimates, benchmarking data, and vendor inputs
- Lead or support final financial reconciliation for vendor engagements
- Establish vendor governance frameworks with KPIs, scorecards, escalation pathways, and performance reviews
- Serve as primary operational contact for CRO and vendor relationships
- Identify and resolve performance, quality, and timeline risks
- Ensure outsourced activities comply with GCP, regulations, and BBOT SOPs; support audit and inspection readiness
- Partner with Clinical Operations teams to integrate outsourced partners and drive accountability for deliverables and milestones
Requirements
What you’ll need- Bachelor’s degree in life sciences, business, or a related field; advanced degree preferred
- Minimum 10 years of experience in clinical outsourcing, vendor management, or clinical operations in a pharmaceutical or biotechnology setting
- Direct experience in CRO contracting, budget negotiation, and financial management
- Experience managing the full vendor contract lifecycle, including RFP development, proposal evaluation, contract negotiation, change order management, and close-out
- Strong financial acumen with hands-on experience supporting clinical trial budget tracking, accruals, and monthly/quarterly finance reviews
- Working knowledge of ICH-GCP and regulatory requirements governing clinical trial outsourcing
- Excellent negotiation, organizational, and communication skills
- Ability to manage multiple vendor relationships and competing priorities simultaneously
- Proven experience independently managing complex, multi-vendor outsourcing programs across global oncology trials (Director level)
- Expertise in CRO and vendor contract negotiation, budget development, and financial oversight at program and portfolio level (Director level)
- Experience establishing preferred provider frameworks and strategic outsourcing models (Director level)
- Deep working knowledge of ICH-GCP, FDA regulations, and global regulatory requirements (Director level)
- Oncology experience preferred; early-phase oncology experience a plus
- Prior experience in a lean, startup, or high-growth biotech environment highly desirable