The Opportunity: 

The Director of Clinical Service Provider Contracting, Early Stage, will lead Service Provider sourcing, requests for information/proposal (RFIs/RFPs), contracting, and governance for assigned early-stage clinical programs.

This role will partner with Clinical Operations and study teams to define service requirements and establish agreements that support first-in-human, dose-escalation, and dose-expansion studies. The Director will manage contracting priorities, negotiate commercial terms, and oversee Service Provider relationships in collaboration with Clinical Business Operations, Finance, Legal, Procurement, and Quality.

• Develop sourcing plans for assigned early-stage studies, aligning Service Provider selection and contracting milestones with study startup and program priorities.

• Generate RFIs, RFPs and budget grids/trackers for clinical trials. Lead RFI/RFP development with study teams, defining scope, deliverables, responsibilities, timelines, budget assumptions, and evaluation criteria.

• Coordinate proposal reviews, bid comparisons, and bid defense meetings, and assist Clinical Development Management with the Service Provider selection process. Evaluate Service Provider capabilities, early-stage oncology experience, capacity, proposed staffing, costs, and delivery risks.

• Document selection recommendations. Partner with Clinical Quality Assurance (CQA), Information Sciences (IS) and relevant functions to ensure all selected Service Providers are qualified and IS Security Assessments are conducted before engagement, according to SOPs and business processes.

• Maintain market intel (rates, KPIs), benchmark proposed rates against market data, and recommend sourcing approaches.

Contract negotiation and execution

• Lead commercial negotiations for Service Provider master service agreements, statements of work, work orders, change orders, and consulting agreements, partnering with Legal on contractual terms and risk.

• Ensure agreements clearly define scope, deliverables, acceptance criteria, pricing, payment milestones, governance, and change control. Coordinate required reviews and approvals through execution.

• Build flexibility into agreements for cohort expansion, protocol amendments, enrollment changes, and evolving early-stage study requirements; document assumptions and triggers for scope changes.

• Partner with Clinical Business Operations and Finance to assess proposed costs, payment terms, and change order impacts against approved study budgets.

• Maintain contract status reporting and complete records of approvals, obligations, and amendments. Manage renewals, extensions, transitions, and closeout for assigned agreements.

• In partnership with management, contribute to the audits of contract and sourcing records to ensure accuracy and completeness.

Service Provider governance and issue resolution

• Establish study-level Service Provider governance with Clinical Operations, including meeting cadence, decision rights, performance measures, and escalation pathways.

• Partner with departments to create standardized key indicators (KxIs) per vendor type, including performance, risk, quality, and financial measures.

• Lead Service Provider business reviews to assess contractual delivery, quality, timelines, staffing, and budget adherence. Track risks, decisions, and corrective actions with accountable owners.

• Resolve Service Provider scope, performance, and commercial issues with study teams; escalate material risks or decisions beyond delegated authority to functional leadership.

• Coordinate review of disputed charges and out-of-scope requests with Clinical Business Operations and Finance, ensuring resolutions reflect agreed terms and approved changes.

• Capture Service Provider performance trends and lessons learned to inform future sourcing decisions and improve contracting and governance processes.

Collaboration and team development

• Coordinate contracting priorities across Clinical Operations, Biometrics, Data Management, Safety, Regulatory, Quality, Finance, Legal, Procurement, and IT as relevant to each engagement.

• Improve RFI/RFP templates, contracting workflows, and governance tools. Mentor contracting colleagues and study teams; manage and develop assigned staff.

Required Skills, Experience and Education:

• Bachelor’s degree in life sciences, business, or a related field and at least 15 years of relevant biotechnology, pharmaceutical, or clinical research experience, or an equivalent combination of education and experience.

• At least 9 years in a management role overseeing individuals in a high performing team environment.

• Minimum of 10 years of direct clinical business operations, outsourcing, and vendor governance experience in a CRO, biotechnology, or pharmaceutical organization, with demonstrated leadership of cross-functional initiatives or teams.

• Experience supporting early-stage oncology studies, including first-in-human, dose-escalation, or dose-expansion programs, and translating evolving study needs into contractual scope.

• Proven ability to lead RFIs/RFPs, evaluate proposals, negotiate complex Service Provider agreements, and manage change orders and contractual obligations.

• Experience establishing Service Provider governance, assessing performance, resolving issues, and coordinating with Legal, Finance, Quality, and study teams.

• Strong understanding of clinical trial cost drivers.

• Working knowledge of applicable regulatory requirements, ICH guidelines, and Good Clinical Practice (GCP).

• Strong negotiation, analytical, communication, and organizational skills, with the ability to manage competing contracting deadlines and influence cross-functional decisions.

Preferred Skills:

• Advanced degree; experience in a growing biotechnology organization and with international early-stage clinical studies.

• Experience with contract lifecycle management and financial systems; proficiency in Excel, Word, PowerPoint, and Smartsheet.

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