Vice President, Associate General Counsel
Invivyd
4 days 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 product development and commercialization.
- Advise on FDA and global regulatory matters across the product lifecycle (development, submissions, advertising/promotion, drug safety).
- Counsel on healthcare laws (e.g., Anti-Kickback Statute, FDCA, False Claims Act, PhRMA Code, FTC, HIPAA, CAN-SPAM, Sunshine Act, state physician gift laws, price transparency, and product liability).
- Advise and support Clinical, Clinical Operations, Regulatory Affairs, and Pharmacovigilance for trial programs and drug development (e.g., informed consent forms, clinicaltrial.gov postings, FDA correspondence/submissions).
- Provide marketing and market access legal support/training; review promotional/digital/social media strategies and support compliant interactions with HCPs and stakeholders.
- Provide medical affairs legal support/training for scientific exchange, research planning, publications, presentations, and related engagements.
- Support corporate compliance policies/SOPs/rules of engagement; coordinate with Legal & Compliance; manage cross-functional initiatives.
- Research legal issues; manage outside counsel for complex matters.
- Lead/support internal and external investigations and litigation.
- Potentially manage one or more legal teams and/or direct reports.
Required/Preferred Skills:
- JD (ABA-accredited); licensed attorney in at least one U.S. state; ability to obtain CT in-house counsel registration.
- 10+ years pharma/biopharma legal experience (law firm experience acceptable); strong commercialization counsel.
- Expertise in relevant federal/state laws, regulatory guidance, and industry codes (labeling, promo, scientific exchange, market access, reimbursement, product liability).
- Experience supporting regulatory and commercialization teams; product launch strongly preferred; buy-and-bill a plus.
- Regulatory affairs and drug safety experience.
- Enforcement landscape knowledge; senior leadership/personnel management; litigation experience a plus.
- Onsite in New Haven, CT at least 3 days/week; periodic travel as directed.
Pay Range:
- $309,000–$383,000 base; eligible for annual short-term incentive and annual long-term incentive (equity).
- Provide strategic, operational, and tactical legal counsel and business advice for product development and commercialization.
- Advise on FDA and global regulatory matters across the product lifecycle (development, submissions, advertising/promotion, drug safety).
- Counsel on healthcare laws (e.g., Anti-Kickback Statute, FDCA, False Claims Act, PhRMA Code, FTC, HIPAA, CAN-SPAM, Sunshine Act, state physician gift laws, price transparency, and product liability).
- Advise and support Clinical, Clinical Operations, Regulatory Affairs, and Pharmacovigilance for trial programs and drug development (e.g., informed consent forms, clinicaltrial.gov postings, FDA correspondence/submissions).
- Provide marketing and market access legal support/training; review promotional/digital/social media strategies and support compliant interactions with HCPs and stakeholders.
- Provide medical affairs legal support/training for scientific exchange, research planning, publications, presentations, and related engagements.
- Support corporate compliance policies/SOPs/rules of engagement; coordinate with Legal & Compliance; manage cross-functional initiatives.
- Research legal issues; manage outside counsel for complex matters.
- Lead/support internal and external investigations and litigation.
- Potentially manage one or more legal teams and/or direct reports.
Required/Preferred Skills:
- JD (ABA-accredited); licensed attorney in at least one U.S. state; ability to obtain CT in-house counsel registration.
- 10+ years pharma/biopharma legal experience (law firm experience acceptable); strong commercialization counsel.
- Expertise in relevant federal/state laws, regulatory guidance, and industry codes (labeling, promo, scientific exchange, market access, reimbursement, product liability).
- Experience supporting regulatory and commercialization teams; product launch strongly preferred; buy-and-bill a plus.
- Regulatory affairs and drug safety experience.
- Enforcement landscape knowledge; senior leadership/personnel management; litigation experience a plus.
- Onsite in New Haven, CT at least 3 days/week; periodic travel as directed.
Pay Range:
- $309,000–$383,000 base; eligible for annual short-term incentive and annual long-term incentive (equity).