Senior Contracts Manager, Clinical Agreements

Kardigan•Princeton, NJ

2d•$153,000 - $199,000•Onsite

About The Position

Kardigan is a heart health company dedicated to making cardiovascular disease preventable and curable. Our mission is to develop targeted treatments for cardiovascular diseases. We are driven by our values: patient-centricity, authenticity, eagerness to learn, winning as a team, and enabling the impossible. These values empower us to make a significant difference in patients' lives every day.

Requirements

At least 7–10 years of relevant contracts experience, with substantial, hands-on experience drafting and negotiating Clinical Trial Agreements and related clinical agreements within the pharmaceutical, biotech, or life sciences industry.
Proven track record negotiating CRO and vendor agreements, data privacy agreements (GDPR/Standard Contractual Clauses), and reviewing Informed Consent Forms.
Working knowledge of the clinical trial regulatory framework (e.g., GCP, ICH) as it relates to contracting.
Comfortable also handling general commercial contracts (vendor, consulting, NDA, MSA/SOW) outside the clinical space.
Experience with contract lifecycle management systems, e-signature platforms (e.g., DocuSign), and collaboration tools
Strong organizational and planning skills, with the ability to triage, prioritize, and manage multiple concurrent negotiations in a fast-paced environment.
Excellent issue-spotting, problem-solving, and communication skills, with the ability to collaborate with individuals at all levels inside and outside the organization.
Proficient in Microsoft Office Suite.
Commitment to integrity, ethical conduct, and handling confidential information with discretion.
Meticulous attention to detail; able to work independently with good judgment and a strong team-oriented mindset.

Nice To Haves

Bachelor’s degree preferred
paralegal certification a plus
prior experience with Agiloft a plus

Responsibilities

Independently draft, review, and negotiate Clinical Trial Agreements (US and ROW), Local Sponsor Agreements, and CRO agreements.
Draft and negotiate clinical-adjacent agreements including Data Sharing and Data Processing Agreements, Standard Contractual Clauses (GDPR), Informed Consent Forms, Early Access/Compassionate Use Program agreements, Pharmacy Agreements, Indemnification Agreements, and Letters of Authorization/POAs.
Serve as the primary contracts point of contact for Clinical Operations, working closely with the team to troubleshoot obstacles that arise during clinical trial start-up, site activation, and ongoing conduct.
Track key clinical contract obligations, milestones, renewals, and deadlines across active studies and sites.
Build and maintain effective working relationships with clinical sites, CROs, CMOs, investigators, and other external clinical stakeholders.
Stay current on clinical trial regulatory and industry requirements (e.g., GCP, ICH) as they affect contract terms.
Draft, review, and negotiate additional company contracts as needed, including vendor and supplier agreements, MSAs, SOWs/WOs, consulting agreements, and NDAs.
Translate business needs into clear, legally sound contract language that balances risk mitigation with operational flexibility.
Serve as a resource to internal stakeholders — including Legal, Procurement, R&D, Finance, and IT — on contracting matters outside the clinical space.
Use Kardigan’s CLM system (Agiloft) for contract intake, drafting, routing, and tracking; partner with the Legal team members responsible for CLM administration on process and workflow questions, without owning system implementation or administration.
Identify, assess, and escalate legal and business risks in a timely manner.
Ensure contractual terms comply with applicable laws, company policies, and industry regulations.
Monitor contract-related activities for compliance with internal policies and applicable law.
Serve as a trusted advisor and liaison to Clinical Operations and other functions on contract negotiation strategy, process, and status.
Communicate contract status, priorities, and risks clearly to stakeholders at all levels.
Partner with the broader Legal team on cross-functional initiatives and process improvements affecting clinical and general contracting.
Support special projects and other contract-related initiatives as needed.
Perform other duties as requested