Vice President, Associate General Counsel, Infectious Disease Franchise

The role

The Vice President, Associate General Counsel, Infectious Disease Franchise provides legal counsel and business advice to various leadership and functional teams. This person supports the development and commercialization of products through legal guidance on regulatory, marketing, and clinical matters.

What you will do

• Provide strategic, operational and tactical legal counsel and business advice related to product development and commercialization
• Advise clients on FDA and global regulatory matters and compliance
• Provide legal counsel on health care laws including Federal Anti-Kickback Statute, FDCA, False Claims Act, and others
• Provide legal advice and material review to Clinical, Clinical Operations, Regulatory Affairs, and Pharmacovigilance teams
• Provide legal advice, counsel and training to the Marketing team
• Provide legal advice, counsel and training to the Market Access team
• Provide legal advice, counsel and training to the Medical Affairs team
• Review materials for the Corporate Affairs team
• Support the creation, review, updating and training of corporate and healthcare compliance policies
• Manage outside counsel resourcing and budget

Required qualifications

• Juris Doctor (J.D.) from an ABA-accredited law school
• Licensed attorney in at least one U.S. state and in good standing
• Ability to obtain CT in-house counsel registration
• Minimum of 10 years of relevant experience with a pharmaceutical/biopharma company or law firm providing life sciences advice
• Expertise in federal and state laws, regulations, rules and guidance impacting pharmaceutical manufacturers
• Experience supporting regulatory and commercialization teams
• Experience supporting regulatory affairs and drug safety
• Knowledge of enforcement landscape including industry litigation and settlements
• Demonstrated senior leadership and personnel management skills and experience
• Experience with digital and social media policies, regulations, guidance and industry practice
• Experience drafting, reviewing and/or interpreting and advising upon written compliance

Nice to have

• Law firm experience
• Law firm experience advising pharmaceutical/biopharmaceutical companies
• Product launch experience
• Buy and bill experience
• Litigation experience

Benefits

• Annual short-term incentive (e.g., bonus or sales incentive)
• Annual long-term incentive (e.g., equity)

About the company

Invivyd, Inc. works to deliver protection from serious viral infectious diseases using a proprietary integrated technology platform to create antibodies. The company has received FDA emergency use authorization for a monoclonal antibody in its pipeline.