Kura’s Legal Department is seeking an experienced and business-minded attorney to provide contracting, product and compliance counsel for the commercialization of Kura’s lead product candidate. This role will primarily support Kura’s Commercial, Medical Affairs and Chemistry, Manufacturing & Controls (CMC) Departments. Qualified candidates will have experience with at least one pharmaceutical product launch.

ESSENTIAL JOB FUNCTIONS:

• Draft, review and negotiate a broad range of agreements related to the commercialization of Kura’s lead product candidate, including:
• commercial manufacturing, supply and 3PL agreements,
• agreements with public and private payers, PBMs, GPOs and specialty pharmacies,
• agreements with healthcare professionals and providers, including advisory board agreements and speaker bureau agreements, and
• services agreements.
• Serve as an internal subject matter expert and provide guidance to internal stakeholders on laws relating to the commercialization of pharmaceutical products in the U.S., including FDA regulations and anti-kickback, fraud and abuse and anti-bribery laws.
• Provide legal guidance on strategies, programs, initiatives and contracts related to sales, marketing, market access, patient advocacy and patient assistance.
• Provide advice on pharmaceutical pricing, reimbursement, price transparency and government price reporting requirements, and support related activities.
• Provide guidance on speaker bureau and advisory board participation and other activities conducted by healthcare professionals at the request of the company.
• Review and provide legal guidance on financial and other interactions with healthcare professionals, patients and others in a position to influence healthcare decisions (e.g., payers, advocacy groups, wholesalers/distributors, healthcare institutions) to ensure compliance with applicable laws and regulations.
• Advise on legal issues related to state licensing, trade, distribution, notification and reporting requirements, and support related activities.
• Provide guidance to internal stakeholders on the interpretation of applicable laws and regulations in a manner that provides practical legal advice and supports business objectives and priorities while appropriately managing risk to the organization.
• Monitor new and revised laws, regulations, guidance documents, industry standards and enforcement actions related to drug product commercialization, and analyze and communicate the relevance of such updates to the business appropriately.
• Develop policies and training materials to support compliance with laws relating to the commercialization of pharmaceutical products.
• Develop contract templates for speaker bureaus, payers and other pre-commercial and commercial activities.

Job Requirements

• Law degree and admission to at least one State Bar (required).
• A minimum of 10 years of in-house and/or law firm experience providing legal advice and counseling on commercial contracting and pharmaceutical commercialization (in-house experience preferred).
• Experience with at least one pharmaceutical product launch.
• Thorough knowledge of pharmaceutical/biotechnology industry and laws, regulations, and guidelines applicable to the development and commercialization of medicinal products, including the Food, Drug and Cosmetic Act, Anti-Kickback Statute, False Claims Act and the Physician Payments Sunshine Act.
• Strong critical thinking skills and the ability to grasp important business and legal issues and to appropriately balance risk mitigation with corporate objectives and priorities.
• Outstanding interpersonal and leadership skills, with the ability to build strong relationships across functions and to communicate effectively with senior business leaders, as well as other professionals and colleagues at all levels of an organization.
• Capacity to manage a significant number of projects simultaneously and to thrive in a dynamic and fast-paced environment.
• Strong attention to detail.
• Proven ability to work successfully both independently and as part of a highly collaborative team. 
• Ability to analyze and interpret legal issues and develop and implement appropriately responsive strategies and solutions.

The base range for a Director is $216,000 - $281,000 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.