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Agenus is seeking a Clinical Trials Attorney to join our dynamic and growing in-house legal team at the most exciting time in our 25+ year history. The successful candidate will have 3+ years of experience drafting and negotiating clinical trial agreements, CRO contracts, reviewing and drafting ICFs, and will have a solid understanding of the clinical study supply chain. The attorney will report to the Associate General Counsel.
Participate in weekly meetings of each clinical study team, both as a legal resource for Clinical Operations and in order to keep Legal current on upcoming changes in clinical plans;
Serve as Legal team’s primary interface with Clinical Development and Clinical Operation teams;
Draft, review and negotiate CRO contracts, in coordination with the Clinical Operations function;
Review and negotiate clinical trial templates and individual site agreements;
Draft, review and negotiate vendor agreements with labs, shipping and handling facilities, and other players in the clinical trial supply chain;
Become familiar with jurisdiction-specific CTA forms and indemnification obligations, and be able to advise on relative risks associated with working in such jurisdictions;
Work closely with and manage CROs in their negotiation of site contracts.
Draft template ICFs and review and revise site-specific ICFs as they come in;
Primary responsibility for legal aspect of Investigator Sponsored Trial program, including drafting and negotiating IST agreements;
Serve as a member of the Legal team supporting the Human Resources function with respect to clinical consultants and external support.
Assist with HIPAA and other data protection compliance.
Develop, implement, review and interpret company policies as needed.
Assist with initiatives to strengthen the Legal department and business operations through systems improvements and the preparation, implementation and refinement of forms, processes, and procedures.
Support Associate General Counsel and General Counsel with general legal matters.
5+ years’ experience as a practicing attorney, with at least 3 years of experience working primarily with clinical contracts.
Significant legal experience drafting, reviewing and negotiating clinical trial agreements and related contracts.
Ability to identify and prioritize issues; solid business judgment.
Experience dealing with the rules and regulations applicable to hospitals, including FDA, HIPAA, and data security matters, telemedicine, fraud and abuse.
Strong negotiation, communication, administrative and time management skills.
Ability to evaluate effectively legal exposure, manage risk and develop creative, client-focused solutions to achieve business goals within appropriate legal guidelines.
The preferred candidate will have worked at a leading U.S. national law firm or had an in-house counsel position with a hospital or biotech/pharmaceutical company.
Working knowledge/experience with GLP, GCP, GMP a plus.
About Agenus Inc.
Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body’s immune system to fight cancer. Agenus’ vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing combination approaches that leverage a broad repertoire of antibody therapeutics, proprietary cancer vaccine platforms, and adoptive cell therapies (through its AgenTus Therapeutics subsidiary). The Company is equipped with a suite of antibody discovery platforms and a state-of-the-art GMP manufacturing facility with the capacity to support early phase clinical programs.