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).
• Fam