Vice President, Associate General Counsel

Role Summary

Hybrid role based in New Haven, CT (Northeast preferred), with three days per week onsite in the New Haven office. The Vice President, Associate General Counsel, Infectious Disease Franchise provides legal counsel and business advice to Commercial, Clinical, Regulatory, Medical and Pharmacovigilance leadership, and to Marketing, Market Access, Clinical Operations, Regulatory Affairs, Medical Affairs, Drug Safety, and Patient Advocacy teams on relevant areas of law, policy, risk, and mitigation strategies. The ideal candidate has significant law firm and/or biopharma company experience across all stages of drug development, with a focus on commercialization and product launches. They will report to the Chief Legal Officer as part of a dynamic Legal and Compliance team.

Responsibilities

• 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 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, regulations, guidance and codes
• Providing and coordinating legal support as a member of cross-functional teams
• Representing the Legal department on cross-functional initiatives and collaborating with other members of the Legal department on internal initiatives
• Researching issues and supporting the company in providing a wide range of legal advice to internal clients
• Managing outside counsel resourcing and budget for complex or nuanced areas of law, regulation or policy
• Lead or support internal investigations on behalf of Legal; lead or support external investigations or litigation, independently, collaboratively, and/or with outside counsel support, as applicable
• Potential for management of one or more legal teams (e.g., Contracts) and/or direct reports, in role currently or to be hired

Qualifications

• Required: Have a Juris Doctor (J.D.) from an ABA-accredited law school; be a licensed attorney in at least one U.S. state and in good standing in all states where you are licensed; and have the ability to obtain CT in-house counsel registration
• Required: A minimum of 10 years of relevant experience with a pharmaceutical/biopharma company providing life sciences advice, counsel and support to pharma/biopharma companies
• Required: Demonstrated expertise in federal and state laws, regulations, rules and guidance impacting pharmaceutical manufacturers, including drug labeling, advertising and promotion, scientific exchange, market access communications, government reimbursement and product liability
• Required: Demonstrated experience supporting regulatory and commercialization teams including providing legal counsel on Medical, Legal, Regulatory review committee, development and implementation of promotional activities, market access communications, drug labeling, scientific exchange
• Preferred: Product launch experience strongly preferred
• Preferred: Buy and bill experience a plus
• Required: Experience supporting regulatory affairs and drug safety in pharmaceutical development and ongoing obligations
• Required: Knowledge of enforcement landscape, including relevant industry litigation, settlements, and corporate integrity agreement obligations
• Required: Demonstrated senior leadership and personnel management skills and experience
• Preferred: Litigation experience a plus

Skills

• Demonstrated leadership and personnel management capabilities
• Strong ability to thrive in a fast-paced environment; critical thinker, issue spotter, and strategic problem solver
• Proactive, flexible, detail-oriented, and hands-on approach
• Ability to collaborate with cross-functional teams and communicate complex legal concepts clearly

Additional Requirements

• Onsite presence: This role is based at Invivyd’s office in New Haven, CT (minimum 3 days a week onsite). Onsite presence is an essential job function.
• Travel: Periodic travel as directed; travel is an essential job function.