Senior Contracts Manager, Clinical Agreements

Position Title: Senior Contracts Manager

Department: Legal

Reports To: Vice President, Corporate Law and Head of Transactions

Location: Princeton, NJ – On-site 4 days per week (Mon to Thurs)

 

 

 

Kardigan is seeking an experienced Senior Contracts Manager to lead the negotiation and management of 
Clinical Trial Agreements and other clinical-related agreements in support of Kardigan’s clinical development 
programs. This is a hands-on drafting and negotiation role — the primary focus is clinical contracting, with 
additional responsibility for general contracting needs across the business as they arise. This role does not have 
ownership of Kardigan’s contract lifecycle management (CLM) system implementation or administration, which 
is led separately within the Legal team. Kardigan seeks an exceptional candidate with strong clinical contracts 
experience who can collaborate cross-functionally, negotiate agreements independently, and communicate 
clearly and effectively with stakeholders at all levels. Attention to detail is essential. You will join our fast-paced 
legal team, reporting to our Vice President, Corporate Law and Head of Transactions, and will interface directly 
with Clinical Operations, R&D, and other business stakeholders across the company.

 

 

Clinical Contracting (Primary Responsibility)

• 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.

General Contracting

• 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.

Risk Management & Compliance

• 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.

Business Partnership

• 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.

General

• Support special projects and other contract-related initiatives as needed.
• Perform other duties as requested

 

Qualifications and Preferred Skills

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