Associate Director, Corporate Counsel, Research & Development

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.

Summary of Job:

The Associate Director, Corporate Counsel, Research & Development (R&D) is responsible for legal expertise and support for contracts and regulatory advice. This position provides legal expertise and support across all business functions engaged in registered clinical trials (Phases 1-4), and other evidence generation activities including investigator-initiated trials, real world evidence, translational research, health economics and outcomes research. The position will need to frequently interact with senior level staff, as well as other constituents within the Company (both within the US and globally) and externally to ensure complete alignment with respect to contract development, approval, and execution, and compliance with laws and regulations governing drug development and evidence generation. In addition, this position will assist with various projects, litigations, and investigations within the Legal Department as needed.

Essential Functions:

• Provide legal support for clinical research and development, including clinical trial agreements, informed consent forms, governance documents, safety agreements, data safety monitoring board agreements, site management agreements, laboratory agreements and other research and development related contracts/documentation.
• Draft contracts and provide substantive legal review of third-party contracts related to R&D and evidence generation.
• Work closely with cross-functional teams supporting the business, including the Global Development Organization, Medical Affairs, Regulatory, Compliance, Finance, Procurement, Tax, and other business functions to facilitate consistent and efficient support for research and development and evidence generation activities.
• Work closely with the Legal Department and business colleagues in preparing guidance and training materials to support the efficient and compliant negotiation of R&D and other evidence generation agreements in the United States and abroad.
• Provide legal counsel on health care laws and regulations, including the Food, Drug and Cosmetic Act and the Federal Anti-Kickback Statute, industry standards, and Company policies, as well as other related health care legal obligations to all relevant business departments within the Company.
• Work closely with the North American Privacy Officer to ensure development programs and evidence generation programs are structured to comply with local and global privacy laws.
• Work closely with other Legal Department colleagues and Compliance professionals to provide consistent and efficient legal and compliance advice in accordance with Company’s healthcare compliance policies and related laws, codes, and regulations to mitigate risk to the Company.
• Potentially supervise and direct activities of Paralegal(s), as well as outside counsel, to ensure efficient and accurate operations.
• Responsible for legal research and drafting memoranda related to client inquiries.
• Responsible for legal support to the Pharmacovigilance (PV) Department.
• Provide legal support for any policy development related to research and development and evidence generation.
• Providing legal support for interactions with patient organizations in relations to US development programs.
• Other ad hoc analysis / projects as deemed appropriate

Job Requirements:

Education

BA/BS required. A Juris Doctorate degree from Accredited Law School is required. Admission to the N.J. State Bar or eligible to obtain a N.J. limited license for in-house counsel.

 

Experience

At least five (5) years legal experience supporting life science clients with contracting and legal issues related to research and development and evidence generation. In-house experience a plus. Must have a good understanding of the pharmaceutical industry and related regulatory environment.

 

Experience with cross-functional teams (including ex-US) and demonstrated ability to collaborate effectively with others to address complex legal, compliance and operational issues.

 

Experience drafting and negotiating contracts such as master servicer agreements, statements of wor