Senior Director, Associate General Counsel - Commercial

JOB SUMMARY:

The Senior Director, Associate General Counsel - Commercial is a key member of the Legal Team who independently provides innovative and strategic legal support and solutions as a brand attorney and the primary legal advisor for the commercial business and operations and supports all U.S. commercialization, including marketing, initiatives of a commercial stage product. The Assistant General Counsel will serve as the Legal reviewer/approver on ARS Pharma's Promotional Review Committee ("PRC") to ensure all advertising, promotional, and medical materials and communications related to ARS Pharma’s product comply with all applicable federal and state laws (including but not limited to the Federal Food, Drug, and Cosmetic Act, the Lanham Act, and the federal False Claims Act) and any regulations/guidance promulgated thereunder, and to reduce as far as feasible potential risk. This role requires significant interaction with senior leadership, providing advice on a variety of legal issues, managing outside counsel, and providing solutions to advance business imperatives.

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Acts as a brand attorney and lead legal advisor for the commercial business and operations supporting all commercialization activities in the U.S.
• Participate as the Legal representative on Company’s Promotional Review Committee.
• Collaborate with other PRC stakeholders, including Medical and Regulatory representatives, to develop and maintain appropriate risk tolerance strategy related to ARS Pharma's advertising and promotional, medical, and disease state materials for the company’s commercialized products.
• Support Market Access function with review and negotiation of contracts with managed care payers/PBMs, government payers (Medicaid, Medicare Part D, VA/DOD), wholesalers and other distributors to execute on ARS Pharma's strategy related to drug access and payer coverage. Support the Company’s Pricing Committee in decision making. Support the development and enhancements to patient access support programs and public interest programs.
• Provide legal advice and counsel to commercial function and collaborate with Compliance in connection with development and implementation if commercialization initiatives, including speaker bureau and advise on stakeholders on the application of various applicable laws and regulations (e.g., the Anti-Kickback Statute, the False Claims Act, the Foreign Corrupt Practices act, HIPAA and other applicable privacy laws and other regulations applicable to a commercial stage pharmaceutical business)
• Maintain up-to-date knowledge of laws, regulations and agency guidance documents, as well as enforcement and compliance landscape as it relates to advertising and promotion of commercial stage pharmaceutical products, Advise appropriate departments within the company of these requirements, the Anti-Kickback Statute, the False Claims Act, the Foreign Corrupt Practices act, HIPAA and other applicable privacy laws and other regulations applicable to a commercial stage pharmaceutical business.
• Support supply chain and quality function in review and negotiation of supply chain agreements for the supply of components and drug product from contract manufacturing organizations and in connection with supply of products to company’s development and commercialization partners throughout the world.
• Assists with Intellectual Property (IP) matters and works with outside IP counsel to manage patent and trademark portfolios
• Manage external counsel and manage to budget
• Produce legal matter reports as necessary
• Provide legal support on corporate communications matters
• Support the Chief Legal Officer with corporate governance matters as necessary
• May establish and implement potential litigation strategies, advise on litigation matters, including pre-litigation claims and alternative dispute resolution matters
• Under the direction of the Chief Legal Officer, lead departmental or cross-functional projects which may include department budget management, legal technology or corporate operations process enhancements
• Provide cross-functional Legal support to the business and bridge critical connections within the organization to solve complex problems and develop new ideas
• Uphold and consistently demonstrate ARS Pharma's Core Values
• Assist Chief Legal Officer and Healthcare Compliance Officer with ad hoc Legal/Compliance projects, as needed
• Other duties as assigned

 EDUCATION AND EXPERIENCE:

• Juris Doctor degree or equivalent required
• Admitted to practice law in California (member in good standing of CA State Bar or another acceptable jurisdiction)
• Minimum of 8+ years of legal experience required, preferably within a national law firm, or commercial stage pharmaceutical/biotech company
• At least 5 years of experience in the Pharmaceutical or Life Sciences industry required with a minimum of 2+ years of legal experience with promotional review of materials for commercial-stage pharmaceutical product(s)

KNOWLEDGE, SKILLS, AND ABILITIES:

• Significant experience supporting legal needs and advising business partners as the primary legal advisor for the commercial business and operations supporting commercialization of approved pharmaceutical products
• Understanding of the Pharmaceutical/Biotechnology industry regulatory environment and significant working knowledge of applicable laws and regulations (Anti-Kickback statute, Federal Food, Drug, and Cosmetic Act, the Lanham Act, and the federal False Claims Act and any regulations/guidance promulgated thereunder, FCPA, HIPAA and other applicable privacy laws) is required
• Experience partnering with business functions to achieve Company and/or departmental expectations and goals as identified by senior management while limiting risk.
• Experience reviewing and negotiating complex agreements including pharmaceutical supply chain and market access agreements.
• Knowledge of legal and regulatory aspects related to commercial and operational contracts, development and licensing agreements in the pharmaceutical, biotech, medical device or diagnostic industry
• Exercises excellent professional judgment
• Is highly responsive and works with a sense of urgency to support business functions in achieving business objectives while limiting risks. Ability to collaborate with internal and external stakeholders to form and maintain productive partnerships.
• Ability to make effective and credible presentations to employees in company’s business groups at all levels on legal issues facing such business groups. Ability to communicate complex concepts clearly and concisely.
• Ability to inspire trust and confidence through effective communication and interpersonal skills.
• Adaptable and able to plan and manage projects from conception to completion in a dynamic environment with independent follow-through. Ability to efficiently manage and oversee both large and small-scale projects in a timely manner
• Ability to be proactive, anticipate the needs of clients and managers, exercise independent judgment and manage multiple projects simultaneously.
• Ability to focus on critical priorities with little or no supervision.
• Strong work ethic and ability to produce high quality work under deadline pressures.
• Demonstrates excellent leadership skills and emotional intelligence
• Possesses excellent organizational skills
• Understands financial concepts and how to manage budgets
• Good working knowledge of and/or skill using electronic systems, including the MS Office Suite, legal/document management systems, and online platforms