Senior Manager, Contracts - Clinical

Nuvalent, Inc. • Cambridge, MA

2d • Remote

About The Position

Reporting to the Head of Contracts, the Senior Manager, Contracts - Clinical will serve as the primary contracts professional working closely with the Clinical function, particularly Clinical Operations. This is a hands-on, high-volume role responsible for the full lifecycle of clinical site agreements and ancillary clinical contracts across Nuvalent’s global study portfolio, currently spanning four concurrent studies including a Phase 3 randomized controlled trial. The ideal candidate has deep experience in global clinical site contracting at a sponsor company or CRO, is comfortable operating with significant autonomy, and has the judgment to know when to resolve an issue independently and when to escalate. This role works directly alongside a peer team of Senior Contracts Managers within a contracts department that is growing alongside Nuvalent’s pipeline.

Requirements

• Minimum of 7 years of contracts experience in the biopharmaceutical or clinical research industry, with at least 4 years focused on vendor agreements, clinical site agreements, investigator agreements, or study start-up contracting; sponsor-side experience preferred, CRO-side experience considered.
• Demonstrated experience negotiating CTAs, WOs, COs, CDAs, and HCP consulting agreements at volume across multiple concurrent studies.
• Direct experience contracting with international clinical sites and working knowledge of applicable legal and regulatory requirements including GDPR data processing considerations.
• Working knowledge of GCP, ICH guidelines, and FDA regulations governing clinical research and their practical implications for contract terms.
• Familiarity with IRB processes and their intersection with site-level contracting.
• Proficiency with contract lifecycle management systems; experience with Agiloft, Ironclad, DocuSign CLM, or comparable platforms required. Agiloft experience a plus; training will be provided.
• Bachelor’s degree or equivalent experience required.

Nice To Haves

• Oncology experience preferred; relevant experience from adjacent therapeutic areas will be considered.
• Familiarity with AI-assisted contract review tools a plus.

Responsibilities

• Draft, review, negotiate, and execute Clinical Trial Agreements (CTAs) with academic medical centers, community research sites, and international investigator sites across global markets.
• Manage the full contract lifecycle from initial draft through execution, amendment, and close-out across a high-volume, multi-study portfolio.
• Coordinate Informed Consent Form (ICF) review as needed in connection with site-level contracting.
• Negotiate and process Work Orders (WOs) and Change Orders (COs) in coordination with Clinical Operations and relevant CRO or vendor counterparties.
• Serve as the primary contracts point of contact for site administrators, legal counsel, and CRO contract teams, maintaining productive counterparty relationships through complex negotiations.
• Draft, review, and negotiate Confidential Disclosure Agreements (CDAs) and Non-Disclosure Agreements (NDAs) for clinical partnerships and site-level engagements.
• Manage consulting agreements for clinical investigators, key opinion leaders, and clinical consultants engaged by Clinical and Clinical Operations, with appropriate escalation of HCP engagements for compliance review.
• Support statements of work and related agreements for Clinical and Clinical Operations vendors.
• Maintain accurate, complete, and timely contract records in Nuvalent’s contract management system (Agiloft), including status updates, executed document storage, and obligation tracking.
• Apply and enforce departmental file naming conventions, version control standards, and repository management protocols.
• Provide timely contract status visibility to Clinical and Clinical Operations business owners and serve as a reliable point of contact for internal stakeholders throughout the contract lifecycle.
• Identify issues requiring escalation and engage appropriate internal resources — including Legal, QA, Regulatory, Clinical Operations, Finance, IT, and Compliance — or external resources including CRO counterparties, outside counsel, or the Data Privacy Officer (DPO).
• Contribute to negotiation playbooks, standard fallback positions, and contract templates for clinical contract types.
• Coordinate with Legal and the DPO on data privacy provisions in clinical agreements, including GDPR data processing terms for EU and international site agreements.
• Utilize AI-assisted contract review tools as integrated into departmental workflow in accordance with established Nuvalent guidance.
• Lead or co-lead department initiatives to support an expanding organization.

Benefits

• medical, dental, and vision insurance
• 401(k) retirement savings plan
• generous paid time off (including a summer and winter company shutdown)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior