Vice President, Associate General Counsel
Invivyd
September 02, 2026
Remote friendly (New Haven, CT)
United States
$309,000 - $383,000 USD yearly
Corporate Functions
Responsibilities:
- Provide strategic, operational, and tactical legal counsel and business advice for the development and commercialization of Invivyd product(s) and product candidate(s).
- Advise on FDA and global regulatory matters and compliance across the product lifecycle (development, submissions, advertising/promotion, drug safety).
- Counsel on healthcare laws including Anti-Kickback Statute, FDCA, False Claims Act, PhRMA Code, FTC, HIPAA, CAN-SPAM, state physician gifts/meals, Sunshine Act, state price transparency, and product liability.
- Provide legal support and create/review materials for clinical trial programs and drug development (e.g., informed consent forms, ClinicalTrials.gov postings, FDA correspondence/submissions) in collaboration with Clinical, Clinical Ops, Regulatory Affairs, and Pharmacovigilance.
- Advise and train Marketing on compliant innovative marketing, including serving as Legal representative for advertising/promotional review and digital/social media initiatives; develop compliant stakeholder interaction strategies.
- Advise and train Market Access on payer strategies, pre-approval information exchange, distribution models, patient support programs, and HEOR studies/communications.
- Advise and train Medical Affairs on scientific exchange, research planning/publications, presentations, and engagements; serve as Legal representative for select scientific exchange review.
- Review Corporate Affairs communications materials (including social media posts).
- Support creation/review/updating/training of corporate and healthcare compliance policies, SOPs, rules of engagement, and related laws/codes; coordinate cross-functional legal support.
- Support cross-functional initiatives and internal investigations; manage outside counsel resourcing/budget; lead/support litigation and investigations as needed.
- Potentially manage legal teams and/or direct reports.
Qualifications / Required Skills:
- J.D. (ABA-accredited); licensed attorney in at least one U.S. state; ability to obtain CT in-house counsel registration.
- 10+ years relevant experience with pharma/biopharma (may include law firm experience), with extensive commercialization counsel.
- Expertise in federal/state laws, regulations, guidance, and industry codes impacting pharma manufacturers (labeling, advertising/promotion, scientific exchange, market access, reimbursement, product liability).
- Experience supporting regulatory and commercialization teams; product launch experience strongly preferred; buy-and-bill experience a plus.
- Experience with regulatory affairs and drug safety obligations.
- Knowledge of enforcement landscape (litigation, settlements, Corporate Integrity Agreements).
- Senior leadership and personnel management experience; litigation experience a plus.
- Onsite in New Haven, CT minimum 3 days/week; periodic travel as directed (essential function).
Pay/benefits:
- Base salary range: $309,000–$383,000; eligible for annual short-term incentive and annual long-term incentive (e.g., equity).
- Provide strategic, operational, and tactical legal counsel and business advice for the development and commercialization of Invivyd product(s) and product candidate(s).
- Advise on FDA and global regulatory matters and compliance across the product lifecycle (development, submissions, advertising/promotion, drug safety).
- Counsel on healthcare laws including Anti-Kickback Statute, FDCA, False Claims Act, PhRMA Code, FTC, HIPAA, CAN-SPAM, state physician gifts/meals, Sunshine Act, state price transparency, and product liability.
- Provide legal support and create/review materials for clinical trial programs and drug development (e.g., informed consent forms, ClinicalTrials.gov postings, FDA correspondence/submissions) in collaboration with Clinical, Clinical Ops, Regulatory Affairs, and Pharmacovigilance.
- Advise and train Marketing on compliant innovative marketing, including serving as Legal representative for advertising/promotional review and digital/social media initiatives; develop compliant stakeholder interaction strategies.
- Advise and train Market Access on payer strategies, pre-approval information exchange, distribution models, patient support programs, and HEOR studies/communications.
- Advise and train Medical Affairs on scientific exchange, research planning/publications, presentations, and engagements; serve as Legal representative for select scientific exchange review.
- Review Corporate Affairs communications materials (including social media posts).
- Support creation/review/updating/training of corporate and healthcare compliance policies, SOPs, rules of engagement, and related laws/codes; coordinate cross-functional legal support.
- Support cross-functional initiatives and internal investigations; manage outside counsel resourcing/budget; lead/support litigation and investigations as needed.
- Potentially manage legal teams and/or direct reports.
Qualifications / Required Skills:
- J.D. (ABA-accredited); licensed attorney in at least one U.S. state; ability to obtain CT in-house counsel registration.
- 10+ years relevant experience with pharma/biopharma (may include law firm experience), with extensive commercialization counsel.
- Expertise in federal/state laws, regulations, guidance, and industry codes impacting pharma manufacturers (labeling, advertising/promotion, scientific exchange, market access, reimbursement, product liability).
- Experience supporting regulatory and commercialization teams; product launch experience strongly preferred; buy-and-bill experience a plus.
- Experience with regulatory affairs and drug safety obligations.
- Knowledge of enforcement landscape (litigation, settlements, Corporate Integrity Agreements).
- Senior leadership and personnel management experience; litigation experience a plus.
- Onsite in New Haven, CT minimum 3 days/week; periodic travel as directed (essential function).
Pay/benefits:
- Base salary range: $309,000–$383,000; eligible for annual short-term incentive and annual long-term incentive (e.g., equity).