Daiichi Sankyo Inc. Assistant General Counsel, Development in Basking Ridge, New Jersey
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Join a Legacy of Innovation 110 Years and Counting!
With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.
The Assistant General Counsel, Development assigned to this position 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. This position will primarily provide legal support to the US R&D organization and corporate division and will also provide legal support to R&D functions in the EU and phase IV studies/post-marketing studies of the Company’s products. The position will be accountable for coordinating and managing the outside counsel services.
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, research collaboration agreements, informed consent forms 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 claims and assist litigation counsel on clinical study litigation. Works with company’s insurance providers to determine coverage of claims and agreement on settlement provisions and negotiates and drafts settlement agreements and other similar documents for such claims. 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 and Clinical Operations. 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 involving the development function. Provides certain legal counsel and direction to the Legal Administration function supporting development/US R&D 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.) primarily to support development/R&D in oncology, immunology and specialty medicine and/or any other therapeutic areas.
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.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
J.D. from Law School of recognized standing, and Bar Admission
8 or more years of post-law school experience. Direct experience in an in-house corporate counsel role supporting business functions is preferred. 2+ years pharmaceutical or biotech environment experience preferred. Experience in pharmaceutical or biotech research and development sector is also preferred. Experience in the oncology therapeutic area is preferred. Experience managing Early Access Programs (EAP) & negotiating complex research collaboration agreements and translational science/medicine research agreements is a plus.
Relevant licenses must be in good-standing with appropriate jurisdictions, professional organizations, etc. and must be either licensed in NJ or qualified to obtain a NJ limited in-house license.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Assistant General Counsel, Development
Legal & Corporate Affairs