Associate Director, Product Counsel

Location: Boston, MA (Hybrid)

Reporting to: VP, General Counsel & Chief of Staff

Orchard Therapeutics, recently acquired by Kyowa Kirin with the goal of accelerating the delivery of new gene therapies to patients around the globe, is looking for a lawyer to provide commercial and compliance legal support. The ideal candidate will have a strong understanding of relevant healthcare laws relating to the sale and promotion of gene therapy products in the United States.

Summary of Key Responsibilities

·         Provide legal support on a broad range of commercial topics and ensure the business is complying with all relevant healthcare laws and company policies.

·         Negotiate commercial agreements, including contracts with hospitals, government entities, payors and others.

·         Provide legal review of materials, including promotional and non-promotional pieces.

·         Advise business colleagues on interactions with key stakeholders, including patients, physicians, payors and others.

·         Educate colleagues by providing training and periodic updates on relevant legal developments.

·         Work directly with relevant business colleagues, and provide pragmatic, solutions-oriented, proactive counseling.

Requirements

Qualifications, Experience and Skills

·         JD from an ABA accredited law school and member of a state bar.

·         Minimum of 3-years post-JD experience advising on legal matters in the life sciences space, whether in a law firm or in-house in the biotech or biopharmaceutical industry, or both. Experience with gene therapy companies preferred.

·         Experience advising on statutes, regulations and guidance documents applicable to promotion of therapeutics, including federal and state anti-kickback statutes, OIG guidance documents and advisory opinions, the False Claims Act and the PhRMA Code. Up-to-date knowledge of applicable laws, regulations and best practices in the field.

·         Ability to effectively manage outside counsel and adhere to a budget.

·         Effective at communicating complex information to stakeholders in an accessible way.

·         High integrity and ability to treat confidential information with great discretion.

·         Exceptional oral and written communication skills, including drafting skills and presentation abilities and strong interpersonal skills.

·         History of working independently on projects, meeting deadlines and juggling multiple matters through strong organizational and prioritization skills.