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ProfileCorporate Counsel, Clinical Development Legal The candidate will serve as a primary legal contact for client groups conducting clinical trials, engaging with clinical research organizations and vendors, and managing processes for clinical trial disclosure and clinical trial data sharing. Will handle a wide variety of legal questions relating to clinical trial conduct, serve on governance committees overseeing clinical trial vendor performance, and handle selected clinical trial transactional matters. Report to the Assistant General Counsel - Quality, Sponsor Oversight and Operations on the Clinical Development Legal team which supports company's clinical trial activities globally. Provide regulatory compliance advice to clients across the clinical trial organization on matters pertaining to processes and procedures in support of clinical trials, with a particular emphasis on the relationship between sponsors, CROs and vendors. Advise on clinical trial vendor quality and performance matters, and serve as primary legal contact for and representative to selected vendor governance committees. Provide legal input on selected clinical trial transactional matters. Provide primary legal support on process and contractual matters relating to clinical trial disclosure and data sharing. Provide subject matter expertise, and legal support and guidance, on the development and application of standard operating procedures (SOPs) and related supporting procedural documents for clinical trial support activities. Provide ad hoc legal support on special projects as needed.
Qualification and Experience
The candidate should have excellent academic qualifications including Bachelor's degree and J.D. degree. Should be a member in good standing of at least one State Bar and admitted to practice in relevant jurisdiction. Must have 7+ years of experience in the pharmaceutical or biotech industry, or at a law firm supporting clients in the pharmaceutical or biotech industry, preferably including some or all of the following: FDA regulatory compliance, Good Clinical Practice (GCP), outsourcing transactions, contract template management. Strong interest in, and commitment to, the legal subject matter relevant to this role is required.
Application Deadline: April 23, 2018.
Ref. #: 4698839
588 Eastern Point Rd
Groton, CT 06340-5160