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 #J-18808-Ljbffr Jobtailor