Vice President, Associate General Counsel
Invivyd
9 hours ago
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 development and commercialization of product(s) and product candidate(s).
- Advise on FDA and global regulatory matters and compliance across the product lifecycle, including product development, regulatory submissions, advertising/promotion, and drug safety.
- Provide legal counsel on healthcare laws (e.g., 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).
- Advise and support Clinical/Clinical Operations/Regulatory Affairs/Pharmacovigilance on clinical trial programs and drug development (including legal review/creation of informed consent forms, clinicaltrial.gov postings, and FDA correspondence/submissions).
- Advise, counsel, and train Marketing on compliant marketing strategies, promotional and non-promotional activities, and digital/social media initiatives; serve as Legal representative for review committees for advertising/promotional strategies and materials.
- Advise, counsel, and train Market Access on payer strategies, pre-approval information exchange materials, distribution models, patient support programs, HEOR studies, and communications.
- Advise, counsel, and train Medical Affairs on proactive/reactive scientific exchange, research planning/support, publications, presentations, and engagements; serve as Legal representative for review committees for select scientific exchange.
- Review Corporate Affairs (communications) materials, including social media posts.
- Support creation, review, updating, and training of corporate and healthcare compliance policies, SOPs, rules of engagement, and related laws/regulations/guidance/codes; coordinate legal/compliance support with Legal & Compliance colleagues.
- Provide and coordinate legal support for cross-functional teams; represent Legal on cross-functional initiatives and collaborate on internal initiatives.
- Research legal issues and provide a wide range of legal advice to internal clients.
- Manage outside counsel resourcing and budget for complex or nuanced areas.
- Lead or support internal investigations; lead or support external investigations or litigation (independently, collaboratively, and/or with outside counsel).
- Potential to manage one or more legal teams (e.g., Contracts) and/or direct reports.
Required Skills/Qualifications:
- J.D. from an ABA-accredited law school; licensed attorney in at least one U.S. state in good standing; ability to obtain CT in-house counsel registration.
- Minimum 10 years of relevant experience with a pharmaceutical/biopharma company (may be combined with law firm experience).
- Demonstrated expertise in relevant federal and state laws/regulations/guidance and industry codes impacting pharmaceutical manufacturers, including drug labeling, advertising and promotion, scientific exchange, market access communications, government reimbursement, and product liability.
- Demonstrated experience supporting regulatory and commercialization teams (Medical, Legal, Regulatory review committees; development/implementation of promotional activities; market access communications; drug labeling; scientific exchange). Product launch experience strongly preferred. Buy-and-bill experience a plus.
- Experience supporting regulatory affairs and drug safety in pharmaceutical development and ongoing obligations.
- Knowledge of enforcement landscape, including relevant industry litigation, settlements, and corporate integrity agreement obligations.
- Demonstrated senior leadership and personnel management skills; litigation experience is a plus.
- Onsite: New Haven, CT office minimum 3 days/week (onsite presence is an essential job function).
- Travel periodically as directed (off-site meetings, ride-alongs/program monitoring, conferences/congresses); travel is an essential job function.
Benefits/Pay:
- Base pay range: $309,000–$383,000. Eligible for annual short-term incentive (bonus/sales incentive) and annual long-term incentive (equity).
Application Instructions:
- Learn more about total rewards at https://www.invivyd.com/careers/.
- Provide strategic, operational, and tactical legal counsel and business advice for development and commercialization of product(s) and product candidate(s).
- Advise on FDA and global regulatory matters and compliance across the product lifecycle, including product development, regulatory submissions, advertising/promotion, and drug safety.
- Provide legal counsel on healthcare laws (e.g., 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).
- Advise and support Clinical/Clinical Operations/Regulatory Affairs/Pharmacovigilance on clinical trial programs and drug development (including legal review/creation of informed consent forms, clinicaltrial.gov postings, and FDA correspondence/submissions).
- Advise, counsel, and train Marketing on compliant marketing strategies, promotional and non-promotional activities, and digital/social media initiatives; serve as Legal representative for review committees for advertising/promotional strategies and materials.
- Advise, counsel, and train Market Access on payer strategies, pre-approval information exchange materials, distribution models, patient support programs, HEOR studies, and communications.
- Advise, counsel, and train Medical Affairs on proactive/reactive scientific exchange, research planning/support, publications, presentations, and engagements; serve as Legal representative for review committees for select scientific exchange.
- Review Corporate Affairs (communications) materials, including social media posts.
- Support creation, review, updating, and training of corporate and healthcare compliance policies, SOPs, rules of engagement, and related laws/regulations/guidance/codes; coordinate legal/compliance support with Legal & Compliance colleagues.
- Provide and coordinate legal support for cross-functional teams; represent Legal on cross-functional initiatives and collaborate on internal initiatives.
- Research legal issues and provide a wide range of legal advice to internal clients.
- Manage outside counsel resourcing and budget for complex or nuanced areas.
- Lead or support internal investigations; lead or support external investigations or litigation (independently, collaboratively, and/or with outside counsel).
- Potential to manage one or more legal teams (e.g., Contracts) and/or direct reports.
Required Skills/Qualifications:
- J.D. from an ABA-accredited law school; licensed attorney in at least one U.S. state in good standing; ability to obtain CT in-house counsel registration.
- Minimum 10 years of relevant experience with a pharmaceutical/biopharma company (may be combined with law firm experience).
- Demonstrated expertise in relevant federal and state laws/regulations/guidance and industry codes impacting pharmaceutical manufacturers, including drug labeling, advertising and promotion, scientific exchange, market access communications, government reimbursement, and product liability.
- Demonstrated experience supporting regulatory and commercialization teams (Medical, Legal, Regulatory review committees; development/implementation of promotional activities; market access communications; drug labeling; scientific exchange). Product launch experience strongly preferred. Buy-and-bill experience a plus.
- Experience supporting regulatory affairs and drug safety in pharmaceutical development and ongoing obligations.
- Knowledge of enforcement landscape, including relevant industry litigation, settlements, and corporate integrity agreement obligations.
- Demonstrated senior leadership and personnel management skills; litigation experience is a plus.
- Onsite: New Haven, CT office minimum 3 days/week (onsite presence is an essential job function).
- Travel periodically as directed (off-site meetings, ride-alongs/program monitoring, conferences/congresses); travel is an essential job function.
Benefits/Pay:
- Base pay range: $309,000–$383,000. Eligible for annual short-term incentive (bonus/sales incentive) and annual long-term incentive (equity).
Application Instructions:
- Learn more about total rewards at https://www.invivyd.com/careers/.