Director, Clinical Contracts

Rapport Therapeutics•Boston, MA

4d•$195,000 - $215,000•Hybrid

About The Position

This role is based in Boston, MA with onsite presence required Monday-Wednesday. As our Director of Clinical Contracts, you’ll help turn clinical plans into action. You’ll own clinical trial agreements, site budgets, and vendor contracts while partnering with Clinical Ops, Legal, Finance, and our CROs to keep studies moving. You’ll help build a contracting process that keeps pace with our growing global portfolio.

Requirements

Bachelor's degree required
10+ years of experience reviewing and negotiating clinical trial agreements, and/or related vendor contracts within a biotech, pharmaceutical, or clinical CRO environment.
Experience with strategic level decision making for the Contracts function.
Demonstrated executive presence, with experience advising senior leadership on contracting risk and strategy
Experience building, leading, and developing a contracts team.
Global contract experience, including familiarity with international site contracting and cross-border legal/privacy considerations.
Deep familiarity with clinical trial agreement structures, and FMV principles.
Working knowledge of FDA regulations and ICH-GCP guidelines as they pertain to clinical contracting.
Strong negotiation skills with a track record of driving agreements to execution efficiently.
Excellent cross-functional collaboration skills, with experience partnering across Legal, Finance, Development, CMC, Quality, Biometrics, Bioanalytics, Regulatory, and Clinical Operations.
Highly organized, with strong attention to detail and the ability to manage a high volume of contracts simultaneously.

Responsibilities

Develop, own, and maintain clinical contract lifecycle strategy (templates, fallback language, and negotiation playbooks) to standardize contracting process as the portfolio scales globally.
Review and negotiate site Clinical Trial Agreements (CTAs) and CDAs
Develop and align contracting strategy with clinical development plan, shaping negotiation strategy and risk tolerances in line with the pipeline stage (e.g., trial scale-up, new geographies).
Lead end-to-end drafting, review, and negotiation of Confidentiality Disclosure Agreements (CDAs), Master Service Agreements (MSAs), Material Transfer Agreements (MTAs), Statements of Work (SOWs), License Agreements, Subscription Agreements
Partner closely with Clinical Operations, outside counsel, Finance, and CRO/vendor teams to design a preferred vendor program and align contract terms with study timelines and budget parameters.
Serve as strategic advisor to Clinical Operations surfacing contract risk, budget exposure, and portfolio-level trade-offs to inform program decisions.
Track contract status, cycle times, and site activation timelines; proactively identify and resolve bottlenecks.
Ensure all agreements comply with applicable regulations (FDA, ICH-GCP, GDPR and other privacy regulations), Fair Market Value (FMV) standards, and company policies.
Maintain accurate, audit-ready contract files and documentation in support of inspection readiness.
Lead technology and process strategy for the Contracts function, including selection, rollout, integration, use of AI and governance of systems and tools, including buy vs. build decisions.
Develop and implement AI strategy and roadmap for the contracts function
Support department headcount plan and structure; hire, mentor and develop a growing team of contract professionals.