Senior Corporate Counsel, Contracts (Clinical Development)
About The Position
The Senior Corporate Counsel, Contracts (Clinical Development) will support the Company’s clinical research and development activities by drafting, negotiating, and advising on a broad range of clinical and research-related agreements. This role partners closely with Clinical Development, Clinical Operations, Biometrics, Medical Affairs, Procurement, and Legal and Compliance teams to enable efficient and compliant execution of clinical programs. The ideal candidate has strong experience with clinical trial agreements and related contracts in a biotech or pharmaceutical setting, excellent judgment, and the ability to manage multiple priorities in a fast-paced environment. Key responsibilities include: Draft, review, and negotiate a wide range of clinical development agreements, including: Clinical Trial Agreements (CTAs). Site agreements and amendments. CRO, SMO, and vendor agreements. Consulting agreements for investigators and key opinion leaders. Data sharing, biometrics, and lab services agreements. Advise internal stakeholders on legal, regulatory, and risk considerations related to clinical development activities. Support contracting strategy and process improvements to streamline clinical contracting workflows. Partner with Clinical Operations and Legal colleagues to identify and mitigate contractual and operational risks. Ensure agreements align with applicable laws, regulations, and company policies (e.g., GCP, FDA/EMA requirements, applicable data privacy laws, anti-kickback, transparency). Manage multiple agreements simultaneously while meeting clinical timelines. Support audits, inspections, and internal reviews related to clinical contracts. Stay current on evolving legal and regulatory developments affecting clinical research.
Requirements
- Juris Doctor (JD) from an accredited law school.
- Active license to practice law and in good standing.
- 10+ years of relevant legal experience, with a strong focus on clinical development or life sciences contracts.
- Demonstrated experience negotiating CTAs and CRO agreements in a biotech, pharmaceutical, or law firm setting.
- Strong understanding of clinical trial operations and regulatory frameworks.
- Excellent drafting, negotiation, and communication skills.
- Ability to work independently and collaboratively with cross-functional teams.
- Strong organizational skills and attention to detail.
Nice To Haves
- In-house experience at a biotech or pharmaceutical company.
- Experience supporting global or multi-region clinical trials.
- Familiarity with contracting tools and CLM systems.
- Experience working in a fast-growing or development-stage company.
Responsibilities
- Draft, review, and negotiate a wide range of clinical development agreements, including:
- Clinical Trial Agreements (CTAs).
- Site agreements and amendments.
- CRO, SMO, and vendor agreements.
- Consulting agreements for investigators and key opinion leaders.
- Data sharing, biometrics, and lab services agreements.
- Advise internal stakeholders on legal, regulatory, and risk considerations related to clinical development activities.
- Support contracting strategy and process improvements to streamline clinical contracting workflows.
- Partner with Clinical Operations and Legal colleagues to identify and mitigate contractual and operational risks.
- Ensure agreements align with applicable laws, regulations, and company policies (e.g., GCP, FDA/EMA requirements, applicable data privacy laws, anti-kickback, transparency).
- Manage multiple agreements simultaneously while meeting clinical timelines.
- Support audits, inspections, and internal reviews related to clinical contracts.
- Stay current on evolving legal and regulatory developments affecting clinical research.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
