Vice President, Associate General Counsel

Location: (Northeast preferred) Invivyd's headquarters is in New Haven, CT. This role will be a hybrid role with 3 days a week required 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 decision makers 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 law firm experience, with a preference for law firm experience advising pharmaceutical/biopharmaceutical companies, and substantial experience at biopharmaceutical/pharmaceutical company(ies) in the relevant areas identified above and below, with extensive experience as commercialization counsel.

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.

• 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, clinical trial.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 materials, digital and social media initiatives, and working with clients to develop appropriate and compliant strategies for interacting with healthcare providers and other stakeholders
• Providing legal advice, business counsel and training (building and delivering) to the Market Access team, including advice on developing and implementing payer strategies, pre-approval information exchange materials, distribution models and materials, patient support programs, HEOR studies and communications
• Providing legal advice, business counsel and training (building and delivering) to the Medical Affairs team on proactive and reactive communications (i.e., scientific exchange, research planning and support, publications), presentations, engagements and other activities; serving as Legal representative on the Company committee responsible for the review of select scientific exchange
• Reviewing materials for Corporate Affairs (communications) team, including social media posts
• Working closely with other Legal and Compliance department colleagues to provide consistent and efficient legal and compliance support to the Company. Supporting the creation, review, updating and training of corporate and healthcare compliance policies, SOPs, rules of engagement, and laws,…