Sr. Director, Contracts 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 Sr. Director, Contracts Counsel will provide legal expertise and support across all business functions within KKNA. The position will oversee and manage the contracting function for all business departments within KKNA. The position will need to frequently interact with senior level staff, as well as other constituents within KKNA and externally to ensure complete alignment with respect to contract development, approval and execution.

• Manage the overall contracting process for KKNA, including contract development, approval and execution within KKNA’s electronic contract management system;
• Partner with all business departments within the Company to support drafting and negotiation of all agreements, including but not limited to: Commercial, Sales & Marketing, Medical Affairs, Patient Advocacy, Public Affairs, Quality, Business Development, Supply Operations, and Research and Development;
• Ensure the electronic contract management system is meeting legal and business needs;
• Coordinate with Procurement, Finance, ICT and other Functions for KKNA’s contracting needs;
• Prepare guidance and training materials to support the efficient and compliant negotiation of KKNA contracts;
• Provide substantive Legal review of contracts from outside parties;
• Mitigate risk to the Company;
• Supervise and direct activities of numerous Paralegals to ensure efficient and accurate operations;
• Work closely with KKNA Legal Department colleagues and Compliance professionals to provide consistent and efficient legal and compliance support to the Company in accordance with all healthcare compliance policies and related laws, codes and regulations.
• Other ad hoc analysis / projects as deemed appropriate.

Education

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

Experience

• At least ten years practicing law. Previous in-house or outside counsel contracting experience in pharmaceutical industry
• Strong contract and negotiating skills
• Experience drafting and negotiating contracts such as master service agreements, statements of work, confidentiality agreements, supply agreements, consulting agreements, and other corporate pharmaceutical-related agreements is required.
• Experience drafting and negotiating agreements such as clinical trial agreements, informed consent forms, confidentiality agreements, delegations of authority and other clinical research-related agreements 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 FDCA, regulations and guidance; federal and state anti-kickback statutes; OIG guidance documents and advisory opinions; and the PhRMA Code.
• Must understand contract law and have strong 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.
• Proven knowledge of corporate legal issues, particular to the pharmaceutical and/or Biotech industry including contract is preferred.
• Proven negotiation skills.

Technical Skills

• Proficient in Microsoft Office (PowerPoint, Word, Excel).
• Familiar with working in a contract management system.

Non-Technical Skills

• Outstanding ability to effectively communicate sound practical legal advice to lawyers and non-lawyers alike, coupled with a strong business acumen.
• Self-motivated, works well independently on projects, meets deadlines, handles multiple projects successfully in a fast-paced environment.
• Strong collaborator and team player.

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.

#LI-JM1

#LI-Hybrid