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Years of Experience
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ProfileAssistant General Counsel The candidate will be responsible for serving as the primary legal advisor for multiple development programs, reviewing product and/or compound materials and drafting and reviewing contracts. Additionally, the person assigned to this position will independently handle legal projects, perform research and advise clients on legal, business and regulatory issues. Will primarily support the firm Pharma Development (DSPD) division and will also support Development functions in the EU and the US Commercial Division. Oversees and manages one or more development programs and provides comprehensive legal support to designated development teams, and some administrative functions, regarding all vendors, projects, internal and external training materials (e.g., client training materials, CRO training materials), study design, subject recruitment materials, clinical study agreements or other documentation for clinical trials. Works with Clinical, Regulatory, and other functions in order to respond and defend subject injury claims made against the company. Retains and works effectively with outside counsel to cost-effectively manage clinical study litigation. Works with company's insurance providers to determine coverage of claims and agreement on settlement provisions. Negotiates and drafts settlement agreements and other similar documents. Provides updates to senior management on various legal issues regarding development programs. Provides strategic direction to the organization in the development of new policies and procedures to support proper processes, reduction of legal risk primarily in research and development areas. Reviews, initiates and creates corporate policies and procedures in these areas. Creates, implements and presents training programs and materials on legal issues for various departments, primarily including Clinical Development. Monitors current developments in several key legal areas and provides Senior Management and other business leaders with updates regarding same. Provides legal support to the various assigned business areas including intercompany arrangements, commercial real estate transactions and other corporate matters. Provides certain legal counsel and direction to the Legal Administration function including direction to Contract Specialist and/or Program Grants Committee (PGC) Coordinator regarding PGC and FMV processes. Prepares legal documents including legal guidance memos and provides legal advice and support on contracts, correspondence (e.g., to regulatory agencies), both independently and for review, approval, and use by Legal Affairs management. Independently negotiates contracts and other issues with third parties (vendors, etc.). Leads or is a major contributor to cross-functional project management teams set up to address mid-sized or large company-driven initiatives. The result of such initiatives may include creating corporate policies (such as SOPs and AOPs) and other applicable guidance documents.
Qualification and Experience
The candidate must have JD degree from Law School of recognized standing, and Bar Admission. Should have 8+ years of post-law school experience. Direct experience in an in-house corporate counsel role supporting business functions is preferred. 2+ years of pharmaceutical or biotech environment experience is desired. Experience in pharmaceutical or biotech research and development sector is a plus. Experience in the oncology therapeutic area is helpful.
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