Associate Director, Clinical Contracts

• Support counsel for Clinical Operations with domestic and international clinical operations-related documents
• Independently draft, analyze, and review legal provisions in confidentiality agreements, clinical trial agreements, informed consent documents, and letters of authorization
• Identify and escape risks, assess impacts, and provide recommendations and practical solutions for contract negotiations and risk mitigation
• Interface with Clinical Operations, Regulatory, and other internal and external stakeholders to resolve issues
• Identify opportunities to improve processes and maximize legal team efficiency
• Assist in developing clinical trial-related policies and procedures
• Maintain an accurate and up-to-date clinical operations document repository
• Assist with negotiation and management of non-clinical operations documents
• Support the Company’s privacy program and review privacy language in contracts and legal documents
• Identify potential intellectual property concerns and elevate them to intellectual property counsel
• Prepare reports, spreadsheets, presentations, and training materials
• Handle other projects and assignments as needed

Requirements

• BA/BS or MS from an accredited U.S. college
• 5-8 years of relevant industry experience
• At least 4 years of industry experience independently negotiating and drafting contracts
• Experience negotiating and drafting international contracts
• Strong drafting skills
• Experience negotiating confidentiality agreements and Work Orders
• Prior in-house experience in a legal or clinical operations department at a biotechnology or pharmaceutical company strongly preferred
• Site experience strongly preferred
• Excellent problem-solving skills and ability to articulate and defend the Company’s positions in negotiations
• Strong practical experience with Excel and PowerPoint
• Ability to meet deadlines and prioritize work strategically
• Knowledge of pharmaceutical and relevant laws, regulations, policies, and industry standards preferred
• Ability to collaborate and work independently in a fast-paced, deadline-driven environment
• Highly effective verbal and written communication skills
• Detail-oriented, discreet, self-motivated, reliable, responsive, and flexible
• Understanding of privacy laws, including GDPR, preferred
• Experience with pharmaceutical supply agreements and commercialization agreements is a plus

Core Competencies

Demonstrates expertise in drafting and negotiating clinical trial agreements, confidentiality agreements, and understanding of privacy laws such as GDPR. Proven ability to collaborate with cross-functional teams and improve legal processes within clinical operations.

Highest-signal resume keywords

• Contract Negotiation
• Clinical Trial Agreement Drafting
• Regulatory Compliance
• Problem-Solving Skills
• Document Management

ATS Optimization Keywords

Hard Skills

• Contract Drafting
• Confidentiality Agreements
• International Contracts
• Pharmaceutical Supply Agreements
• Commercialization Agreements
• Excel
• PowerPoint
• Legal Document Review
• Risk Assessment
• Policy Development

Soft Skills

• Effective Communication
• Detail-Oriented
• Self-Motivated
• Reliable
• Flexible

Industry Keywords

• Clinical Operations
• Biotechnology
• Pharmaceutical
• GDPR
• Privacy Laws
• In-House Legal Experience
• Stakeholder Engagement
• Process Improvement
• Intellectual Property
• Regulatory Standards