Director, Corporate Counsel-Rare Disease

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 areas of unmet need: oncology, nephrology, immunology and CNS/movement disorders. The North America organization includes three offices (in New Jersey and California) that focus on drug discovery, product development, and commercialization. Together, we work as a close-knit team to understand clinical needs and advance innovations that can have a profound impact on patient lives.

Summary of Job: The Director, Corporate Counsel Rare Disease will serve as the legal advisor to the US Commercial, Patient Advocacy, Public Affairs, Regulatory, and Medical Affairs teams supporting our Rare Disease Franchise, and will coordinate legal services with the attorney responsible for Canadian support for the Rare Disease Franchise.

This is a hybrid role, requiring at least two (2) days a week in our Princeton, NJ office.

Essential Functions: Advise business partners on various Commercial, Patient Advocacy, Public Affairs and Medical Affairs initiatives in a way that advances the Companys strategy while addressing legal risks and protecting the companys integrity and reputation. You will be a key member of the North American Legal team.

Provide solution oriented legal support on all aspects of a commercial business, including lifecycle management, for a marketed Rare Disease product. You will act as a subject matter expert and stay abreast of evolving healthcare legislation, regulations, and enforcement, enabling the provision of sound legal advice. You will be responsible for advising on matters relating to the Food, Drug, and Cosmetic Act (FDCA) and its regulations; advertising and promotion strategies and activities; dissemination of scientific information; product development and labeling; market access initiatives; healthcare fraud and abuse; distribution of drugs; patient engagement and advocacy; patient services/support programs (e.g. coupons, PAPs); and other matters relevant to the development and commercialization of prescription drugs.

Serve as lead lawyer on Rare Disease cross-functional teams and committees, including without limitation, the franchise/brand team, the promotional and scientific material review committees, the social media committee, the grant committee, and the publication committee.

Review business materials (e.g., brand plans, medical plans, strategic initiatives, training documents) requiring legal input and advise internal clients, partners, and stakeholders on compliant strategies, plans, and tactics.

Counsel on appropriate relationships and engagement with a variety of external parties, including healthcare professionals, patients, academic institutions, patient advocacy organizations, and payors.

Issue guidance related to the reimbursement landscape in the U.S. preferred, with emphasis on the Inflation Reduction Act, government pricing regulations and industry issues, such as co-pay accumulators and maximizers.

Work collaboratively with Compliance colleagues to develop and implement training to internal clients, partners, and stakeholders on key policies, procedures, and requirements for healthcare compliance. Educate clients, partners, and affiliates about current U.S. enforcement trends.

Collaborate with other franchise attorneys and assist with special projects and contracting across franchises as workload necessitates.

Ability to manage and mentor junior attorneys and paralegals/contract managers.

Partner with internal clients to identify and understand their business requirements and negotiate contracts in accordance with those requirements and the Companys overall objectives and policies.

Job Requirements Education J.D., License in good standing to practice law in New Jersey (including NJ limited in-house license to practice law).

Experience Seven or more years practicing law. Previous in-house or outside counsel experience supporting commercialized rare or ultra-rare disease product(s) preferred.

Strong knowledge of and experience in advising on statutes, regulations, and guidance documents applicable to commercial operations and medical activities, including, the FDCA, its regulations and FDA guidance documents; federal and state anti-kickback statutes; OIG guidance documents and advisory opinions; the False Claims Act; and the PhRMA Code.

Experience in providing legal support for patient services, specifically internal HUB operations.

Experience on promotional review committees.

Strong contract and negotiating skills.

Technical Skills Proficient in MS Office Suite.

Non-Technical Skills Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. Strong interpersonal and communication skills. Strong work ethic. Detail oriented and excellent follow through. Ability to flex and deal with ambiguity in a dynamic, fast-paced, high growth environment. Maintain a passion for personal learning and development. Understand cultural sensitivity and exercise the ability to develop consensus within a multinational organization.

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 500 Carnegie Center Drive Suite 600 Princeton, NJ 088540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controllers data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controllers 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 Controllers 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 usprivacyoffice@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.

#J-18808-Ljbffr