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 work, confidentiality agreements, clinical research agreements, contract research organization agreements, clinical supply agreements, consulting agreements, clinical trial site agreements and related agreements including collaborative research with industry and government partners and other corporate pharmaceutical-related agreements is required. Must understand contract law and have effective communication and negotiation skills and the ability to influence and work collaboratively at all levels and across functions. Proven ability to interpret and apply legal requirements to specific projects and agreements. Demonstrate understanding of the U.S. Legal requirements related to the pharmaceutical industry, with focus on research and development and evidence generation. Strong grasp of relevant federal and state laws, regulations, rules, and guidance as well as industry codes and principles impacting pharmaceutical manufacturers, focused on FDA laws and regulations fraud, and abuse (Anti-kickback statute, product liability and pharmacovigilance. Knowledge of enforcement landscape, including relevant industry investigations, litigation, and settlements. Strong grasp of relevant federal and state laws, regulations, rules, and guidance as well as industry codes and principles impacting pharmaceutical manufacturers, focused on FDA laws and regulations fraud, and abuse (Anti-kickback statute, product liability and pharmacovigilance). Knowledge of enforcement landscape, including relevant industry investigations, litigation, and settlements. Technical Skills Advanced proficiency in MS Office Suite (Word, Excel, Outlook) Non-Technical Skills Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. Strong interpersonal and communication skills including negotiation skills. Strong work ethic is required. Detail oriented and excellent follow through. Has the ability to flex and deal with ambiguity in a dynamic, fast-paced, high growth environment. Has a passion for personal learning and development to be able to grow with the company. Cultural sensitivity and ability to develop consensus within a multinational organization. Physical Demands: Normal office environment with prolonged sitting and extensive computer work. Working Conditions: Requires up to 10% domestic and international travel KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. ( Controller ), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing ...@kyowakirin.com. Controller's data protection officer can be contacted at ...@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller's recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 ( GDPR ) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller's behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at ...@kyowakirin.com. Recruitment & Staffing Agencies Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-Hybrid #LI-JC1