Director, Corporate Counsel

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.

As a patient centric organization that strives to deliver innovative medicines to meet unmet needs, we feel that it is critical to follow the safety guidelines defined by CDC and OSHA. We believe the COVID-19 vaccine is the best way to manage COVID risk to you, your colleagues, your family and our society. With that in mind, we are taking the essential step to ensure the safety of our employees during this health crisis by requiring all US employees, temporary workers, agency employees and independent contractors to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. In accordance with applicable law, individuals may seek an accommodation for medical or disability-related conditions or sincerely held religious beliefs.

The Director, Corporate Counsel will serve as a primary legal advisor to assigned functions, Franchises and/or compounds/brands in the United States. The Director, Corporate Counsel, will be a trusted partner to the business to drive operational and business success commencing pre-launch through commercialization in accordance with all applicable laws. The Director, Corporate Counsel reports directly to the Senior Director, Senior Corporate Counsel.

• Responsible to draft and review contracts as well as perform legal research to advise business partners on legal and regulatory issues impacting the commercial and research and development business. Understanding of managed markets contracting is preferred.
• Advise business partners on various commercial, patient advocacy, public affairs, market access and medical affairs initiatives pre and post launch in a way that advances the company’s strategy while addressing legal risks and protecting the company’s integrity and reputation.
• You will act as a subject matter expert and stay abreast of evolving healthcare legislation and regulations and the enforcement landscape in order to provide sound legal advice.
• You will be responsible for advising on matters relating to FDA laws and regulations; advertising and promotion strategies and activities; dissemination of scientific information; product development and labeling; market access initiatives; healthcare fraud and abuse; patient engagement and advocacy; patient services/support programs (e.g. HUBs, coupons, PAPs, independent disease state charity donations); and other matters relevant to the development and commercialization of prescription drugs.
• Serve as lead lawyer on cross-functional teams including without limitation, franchise/brand team, promotional and scientific material review committees, grant committees, and publication committees.
• Strong experience in promotional/medical review committees is required.
• Review business materials (including brand plans, medical plans, MSL KPIs, strategic initiatives, training documents, and market research proposals) 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.
• Work collaboratively with Compliance colleagues to develop and implement training to internal clients and external partners on key policies, procedures, practices, and requirements for healthcare and related legal compliance including innovative business initiatives and, current government enforcement trends.
• Collaborate with other members of the NA legal team and assist with special projects as workload necessitates.

Education
Bachelor’s Degree required. JD from Law School of recognized standing required. Admission to NJ Bar and/or qualification for NJ limited in-house license (with reciprocal Bar Admission in another state) required.

Experience
At least 7 years post-JD experience. Previous in-house experience supporting commercialized prescription products is strongly preferred.  At least 2 or more years pharmaceutical or biotech industry experience, particularly in contracting and FDA/fraud and abuse regulatory issues is required. Strong knowledge of and experience advising on statutes, regulations, and guidance documents applicable to commercial operations and medical affairs activities, including: research and interpretation of the Food, Drug, and Cosmetic Act; federal and state anti-kickback statutes; OIG guidance documents and advisory opinions; the False Claims Act; and the PhRMA Code.  Sound understanding of social media and digital platforms.  Strong contract and negotiating skills. Familiar with working in contract management system is preferred. Outstanding ability to effectively communicate sound practical legal advice to lawyers and non-lawyers alike, coupled with a strong business acumen and understanding of business needs and functional roles/responsibilities. Must be able to effectively execute on day- to-day tactical responsibilities while also implementing strategic imperatives that will move the organization

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 is required. Detail oriented and excellent follow through.   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.

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 135 Route 202/206, Suite 6, Bedminster, NJ 07921 USA and can be contacted by emailing [email protected]. Controller’s data protection officer can be contacted at [email protected]. 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 [email protected].

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.

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