Vice President, Associate General Counsel, Infectious Disease Franchise
ExternalPrepare for this interview
EliteAI-generated questions, company research, and talking points tailored to this role
About the role
There are more than 9 million immunocompromised people in the United States. Almost half a million of those represent a population that are moderately to severely immunocompromised and at highest risk for severe COVID-19, including stem cell and solid organ transplant patients as well as those with hematologic cancers. At Invivyd, Inc., we take those numbers very seriously and we come to work each day on a mission to deliver protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024 , Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates. In October 2025 , the FDA cleared the company's Investigational New Drug (IND) application and provided feedback to advance the company's REVOLUTION clinical program, Invivyd's development program for VYD2311, a vaccine alternative monoclonal antibody being investigated for the prevention of COVID-19. Be part of making a difference. Be part of Invivyd. Location: (Northeast preferred) Invivyd's headquarters is in New Haven, CT. This role will be a hybrid role with onsite presence approximately 5-10 days a month in the New Haven, CT office. Position Summary: The Vice President, Associate General Counsel, Infectious Disease Franchise will be responsible for providing legal counsel and business advice to, as well as preparing and reviewing materials for Commercial, Clinical, Regulatory, Medical and Pharmacovigilance leadership and the Marketing, Market Access, Clinical and Clinical Operations, Regulatory Affairs, Medical Affairs, Drug Safety, and Patient Advocacy teams, among others, in part, such as Corporate Affairs and Corporate Communications, on relevant areas of law, policy, business opportunity, risk, and mitigation strategies. The ideal candidate will have significant experience in a law firm and/or pharmaceutical or biopharma company(ies) with all stages of drug development, with a key focus on commercialization and product launches. Responsibilities include providing legal advice and business counsel to leadership and the business and creating and reviewing materials concerning a broad range of legal issues, including application and interpretation of laws, regulations, guidance, code and process in connection with drug development, regulatory strategy, product labeling, promotional and non-promotional activities, medical strategies and activities, marketing and market access strategies and activities, interactions with formulary decisionmakers and healthcare professionals, patient advocacy engagement, among other areas such as corporate communications. Reporting to the Chief Legal Officer, this position will be part of a dynamic Legal and Compliance team. The ideal candidate will have strong substantial experience at biopharmaceutical/pharmaceutical company(ies) in the relevant areas identified above and below, with extensive experience as commercialization counsel, and law firm experience (preferred), with a preference for law firm experience advising pharmaceutical/biopharmaceutical companies, and . The ideal candidate is someone who thrives in a fast-paced environment, who is a critical thinker, issue spotter, and strategic problem solver, and who is proactive, flexible, detail-oriented, and hands-on. Responsibilities include, but are not limited to, the following: Providing strategic, operational and tactical legal counsel and business advice related to the development and commercialization of Invivyd's product(s) and product candidate(s) Advising clients on FDA (and global regulatory authority) regulatory matters and compliance with laws, rules, regulations, guidance and industry standards that arise throughout a product lifecycle, including in the areas of product development, regulatory submissions, advertising and promotion, and drug safety Providing legal counsel on health care laws, including the Federal Anti-Kickback Statute, FDCA, False Claims Act, PhRMA Code, FTC, HIPAA, CAN-SPAM, state laws on physician gifts/meals, Sunshine Act, state price transparency reporting, product liability statutes and related health care legal obligations Providing legal advice, business counsel, material review and creation (e.g., informed consent forms, clinicaltrial.gov postings, FDA correspondence and submissions,) to Clinical, Clinical Operations, Regulatory Affairs, Pharmacovigilance relating to clinical trial programs and drug development Providing legal advice, business counsel and training (building and delivering) to the Marketing team on innovative marketing strategies, activities, programs and trainings, including serving as the Legal representative on the Company committee responsible for the review of advertising and promotional strategies and
Benefits
Your Match
How well this role fits your profile.
Company Intel
What employees say
Worked at invivyd? Share your experience