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Our client, a publicly-traded biopharmaceutical company in New York, is seeking an Associate Director, Counsel Global Clinical Development to join the Law Department.
Summary: As part of the Pharmaceutical Legal Operations Department, this attorney will provide legal support to the Global Clinical Development teams supporting the company’s robust clinical pipeline. The Associate Director will be responsible for providing advice and counsel on a wide range of legal and regulatory issues related to drug discovery and development. The attorney will serve as a proactive, solutions-oriented ethical counselor to internal clients. The ideal candidate will have knowledge of the Food, Drug & Cosmetic Act as well as other laws and regulations impacting the healthcare industry. Experience with the False Claims Act, Anti-Kickback Statute required. Knowledge of privacy laws, ICH GCP and FDA regulations relating to clinical trials a plus.
Responsibilities • Provides advice and counsel to clinical teams accountable for day-to-day management and operations of clinical studies across various therapeutic areas • Partner with Regulatory and Pharmacovigilance teams to ensure compliance with laws and regulations • Provide legal support to teams handling GCP non-compliance investigations • Serve as a subject matter expert on clinical matters within the Law Department and collaborate with other legal functions (e.g., Business Development and Contracting, Compliance, Litigation and Products/Regulatory Law group) • Conduct training to client groups on a variety of legal and regulatory issues Experience And Required Skills : • BA/BS and JD with excellent law school credentials • Licensed to practice law in New York or be eligible for licensure as a registered in-house counsel • 5+ years experience; biotech/pharmaceutical experience required. In-house experience a plus but not required.
Essential Skills and Abilities • Exceptional communication skills, including presentation capabilities, interpersonal skills and conflict resolution. • Excellent negotiation skills requiring strong interpersonal communication and oral and written communication skills. • Willingness to learn, adapt and grow with a highly successful science-based biotech • Ability to persuade with verbal and written communications involving multiple key client groups. • Ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with the client organizations. • Ability to work independently on projects, set and meet aggressive deadlines, and juggle multiple matters.
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