An exciting new opportunity has opened up for a Director, Legal Affairs and Compliance to provide proactive and collaborative legal support in connection with one or more of VBI’s products and act as a legal advisor to our Commercial, Medical Affairs, and Regulatory teams. The ideal candidate will have a deep understanding of U.S. healthcare laws (Canada and Europe experience is a plus), including the Food, Drug, and Cosmetic Act, and laws related to the research and development, manufacturing, quality, regulatory, sales, and marketing of vaccines (including healthcare fraud and abuse laws). Additionally, this role will oversee the commercial compliance of VBI, coordinating with the Compliance team at the Company’s contract commercialization organization.
This work will include, providing solutions-oriented legal advice and counsel, identifying and communicating risks to leadership, ensuring ongoing commercial compliance, drafting and reviewing medical affairs and commercial contracts/agreements, and providing legal review as part of the Medical Review Committee and Promotional Review Committee. Within our highly regulated, dynamic and fast-paced environment, this role works across multiple functional areas. Navigating through the nuances of these relationships is critical to success in this role.
- Serve as the primary legal support for the company’s commercialized product(s) and related business functions. This includes providing legal advice and counsel on marketing and medical affairs strategies, promotional tactics and materials, advertising campaigns and programs, labeling, healthcare fraud and abuse laws, anti-kickback statute and other laws impacting the commercialization of a vaccine in the U.S., Canada, and Europe.
- Proactively identify potential legal risks, formulate and communicate compliant and practical solutions that meet corporate and branded strategic objectives and priorities.
- Serve as legal representative on Medical, Legal, Regulatory (MLR) Review Committees – including for both medical and promotional material.
- Coordinate with Compliance Team at contract commercialization organization to identify and develop policies, training, and monitoring required in-house to ensure good commercial practice and compliance.
- Understand business priorities, fiscal impacts and implications. Balance legal risks with the need to meet business priorities. Partner with the Core Launch Team to identify creative strategies to keep within budget goals and expectations.
- Conduct thorough and reasoned analysis of complex legal issues, and develop creative and effective solutions using in-depth knowledge of the company, product, relevant laws and regulations, the external environment, and industry best practices.
- Draft and/or review, and negotiate a wide variety of medical affairs and commercial contracts with service providers, suppliers, research sites, speakers, advisors, partners, and collaborators. Apply legal expertise to effectively manage risks on contractual matters.
- Identify the need for new, or updates to existing, policies and procedures. Provide legal and compliance expertise whilst partnering with the business to develop meaningful and relevant policies, SOPs, and guidance documents.
- Keep abreast of legislation, pharmaceutical, regulatory and policy initiatives in order to counsel business leaders on potential legal risks in a way that continues to advance corporate strategy while protecting corporate assets, integrity and reputation
- Consult with and work collaboratively with global, cross-functional teams to support transactions and new initiatives
Qualifications & Experience
- A Solid understanding of commercialization, contracts, and related law within the biotech/vaccine industry
- Juris Doctorate (J.D.) licensed to practice in the U.S. or be eligible for licensure as a registered in-house counsel.
- 5-10 years of combined experience at a law firm and/or in-house, including biotech/pharmaceutical and/or healthcare experience (vaccine experience a plus)
- Experienced in advising clients/companies on laws and regulations governing the pharmaceutical industry, including but not limited to FDA regulations, Health Canada regulations, European Medicines Agency regulations (MHRA regulations a plus), False Claims Act, Anti-Kickback Statutes, OIG guidance, the PhRMA Code, privacy laws like HIPAA or GDPR, and product liability laws.
Skills and Abilities
- Ability to work well independently, while meeting aggressive deadlines and prioritizing multiple matters
- Must be self-motivated, proactive, strategic, and exhibit excellent judgement
- Possess the ability and willingness to advance new and creative ideas and to recognize when decisions may have broader impact on the global organization
- Strong interpersonal skills and conflict resolution skills, with ability to work within a cross-functional team environment
- Excellent written and communication skills with the ability to explain complex legal concepts to a varied audience
- Superior attention to detail and able to analyze legal decisions, laws, and contracts