About Us

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.

• 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.