Location: (Northeast preferred) Invivyd's headquarters is in New Haven, CT. This role will be a hybrid role with onsite presence approximately 5-10 days a month 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 decisionmakers 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 substantial experience at biopharmaceutical/pharmaceutical company(ies) in the relevant areas identified above and below, with extensive experience as commercialization counsel, and law firm experience (preferred), with a preference for law firm experience advising pharmaceutical/biopharmaceutical companies, and .
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.
Responsibilities include, but are not limited to, the following:- 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
Required Skills:- 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
- A minimum of 10 years of relevant experience with a pharmaceutical/biopharma company (can be combined with relevant experience at a law firm) providing relevant life sciences advice, counsel and support to pharma/biopharma companies
- Demonstrated expertise in relevant federal and state laws, regulations, rules and guidance as well as industry codes and principles impacting pharmaceutical manufacturers, including but not limited to applicable law concerning drug labeling, advertising and promotion, scientific exchange, market access communications, government reimbursement and product liability
- 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. 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 and experience
- Litigation experience a plus
Additional Requirements:- Possess and demonstrate exceptional judgment, self-management, impeccable ethics and a high degree of personal and professional maturity
- Strong sense of accountability and ownership
- History of self-motivation, sound judgment and excellent interpersonal relations including being a team player and building collaborative, effective relationships within the Legal and Compliance Department and with other functions
- Demonstrated experience in thinking critically and connecting the dots across broad areas to identify and analyze complex, novel, and challenging issues, well-articulating the risk and potential consequences for transparent decision making, and timely providing compliant, practical, creative and implementable solutions
- Excellent communication skills (both verbal and written); strong leadership skills
- Experience with digital and social media policies, regulations, guidance and industry practice
- Experience drafting, reviewing and/or interpreting and advising upon written compliance
- Demonstrated ability to be a valued business partner
- Exceptional multi-tasker with strong work ethic to deliver timely, high-quality work product
- Thrive in a fast-paced, rapidly evolving environment and view obstacles as opportunities
- Proactive in identifying issues, opportunities and solutions for short and long-term success and growth for the business and legal team
- Highly collaborative; ability to work independently and as a teammate in a remote environment
- Positive, growth mindset
- Interest and ability to learn the business and the science, and build relationships with clients to effectively prioritize and deliver exceptional results
- Team player willing to support the legal team and business on broader initiatives and pitch-in where needed
- Strong interpersonal, written and verbal communications skills
- Strong problem-solving and decision-making skills with demonstrated ability to think creatively and devise solutions to challenging problems
- Have a high-quality and continuous improvement orientation, ensuring we are staying current with relevant laws, regulations, guidance, policies and codes in how we identify and mitigate risk and provide solutions to the business
- This role is based at Invivyd's office in New Haven, CT (minimum 3 days a week onsite). Onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture
- Ability to periodically travel (e.g., to attend company off-site meetings; field ride-alongs/program monitoring; attend meetings on behalf of Invivyd, such as conferences/congresses), as directed. Travel is an essential job function
Pay Range$309,000 - $383,000The pay range represents the expected full-time base salary for this role at the time of posting. Actual base pay will be determined based on a variety of factors, including relevant experience, skills, and education. In addition to base pay, this role is eligible for both an annual short-term incentive (e.g., bonus or sales incentive) and an annual long-term incentive (e.g., equity), reflecting our commitment to rewarding strong performance and long-term impact. Learn more about our total rewards by visiting https://www.invivyd.com/careers/.
