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Senior Corporate Counsel
Refer job# LGSG170535
 
Senior Corporate Counsel Duties: Serve as a business and legal partner for the Clinical and Regulatory organizations, including the clinical operations, quality and CMC teams. Supervise and provide guidance, mentorship and support to direct and indirect reports within the Legal department. Draft and negotiate corporate and commercial agreements, including clinical trial site agreements, CRO agreements, vendor agreements, manufacturing and other supply chain agreements, licensing agreements and MSAs. Support all aspects of clinical trial start-up and continuation, both in the U.S. and ex-U.S. Work collaboratively with business and legal colleagues to develop pragmatic, creative and compliant solutions. Prepare guidance and training materials to support the efficient and compliant negotiation of documents relating to vendor, clinical, regulatory and compliance matters. Provide timely, pragmatic and accurate counsel to clients on a variety of legal, regulatory and compliance topics. Develop and manage internal policies and monitor compliance. Evaluate risks regarding business decisions and operations, apply effective risk management techniques and offer proactive advice on potential legal issues. Effectively communicate and negotiate with external parties (e.g., regulators, external counsel, public authorities and other companies). Demonstrate strong communication skills (both written and verbal) and the ability to drive discussions to effective and actionable conclusions.

Qualifications: JD degree from an accredited, top-tier law school. Must have 10+ years of legal experience. Prior professional experience in-house at a life science/pharmaceutical company, government agency or healthcare institution, working on healthcare and clinical trial-related matters. Significant experience drafting and negotiating corporate and commercial agreements, including clinical trial site agreements, CRO agreements, vendor agreements, manufacturing and other supply chain agreements and licensing agreements. Knowledge of current laws, regulations and industry standards governing clinical trials, such as FDA regulations, ICH Guidelines and GCPs. Strong legal, communication (both verbal and written), customer service and negotiation skills. Proven ability and interest in working across a broad range of subject matter areas and succeeding in the fast-paced environment of a biotechnology company. Demonstrated ability to identify potential legal issues and propose solutions to address business requirements, while appropriately mitigating risk. Capable of appropriately triaging workflow, setting clear priorities and expectations with clients and external parties, and efficiently delivering results in a pragmatic and risk-balanced manner. Team player with the ability to develop and maintain strong business relationships across the company and to contribute to cross-functional and departmental projects. Demonstrated flexibility within a rapidly changing environment. Well-developed organizational skills, strong attention to detail, and the ability to thrive under pressure. The high degree of integrity, ethics, and accountability. Managerial experience is desired. Intermediate to advanced software skills (e.g., Microsoft Excel, PowerPoint, MS Project). Admission to State Bar associations in the U.S.; New York or California is a plus.
 
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