Vice President, Associate General Counsel, Infectious Disease Franchise

Invivyd•New Haven, CT

49d•$309,000 - $383,000•Hybrid

About The Position

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. 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.

Requirements

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
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

Nice To Haves

Law firm experience advising pharmaceutical/biopharmaceutical companies
Buy and bill experience a plus
Litigation experience a plus

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