Senior Director, Commercialization and Development Counsel

Lifelancer•New Haven, CT

1d•Hybrid

About The Position

There are more than 9 million immunocompromised people in the United States. Almost half a million of those represent a population that are moderately to severely immunocompromised and at highest risk for severe COVID-19, including stem cell and solid organ transplant patients as well as those with hematologic cancers. At Invivyd, Inc., we take those numbers very seriously and we come to work each day on a mission to deliver protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024 , Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates. In October 2025 , the FDA cleared the company's Investigational New Drug (IND) application and provided feedback to advance the company's REVOLUTION clinical program, Invivyd's development program for VYD2311, a vaccine alternative monoclonal antibody being investigated for the prevention of COVID-19. Be part of making a difference. Be part of Invivyd. Location: (Northeast preferred) Invivyd's headquarters is in New Haven, CT. This role will be hybrid with a mix of both onsite (New Haven, CT) and remote working. Position Summary The Senior Director, Commercialization and Development Counsel will report to the Chief Legal Officer and Corporate Secretary, and will be responsible for providing legal counsel and business advice to Commercial, Clinical, Medical and Pharmacovigilance leadership and the Marketing, Market Access, Regulatory Affairs, Medical Affairs and Drug Safety teams 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 biotech, biopharmaceutical or pharmaceutical company(ies) with drug development, 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, among other areas. The ideal candidate is someone who thrives in a fast-paced environment, is a strategic problem solver, and is proactive, flexible, detail-oriented, and hands-on.

Requirements

Juris Doctor (J.D.) from an ABA-accredited law school; be an attorney in good standing with license to practice in the state where you reside; and have the ability to obtain a MA in-house counsel registration
A minimum of 7 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
Significant experience representing Legal on Promotional Review Committee
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
US employment law 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
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
Highly collaborative; ability to work independently and as a teammate in a hybrid environment
Positive, growth mindset
Interest and ability to learn the business, 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 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
Ability to periodically travel (e.g., to attend company and/or department meetings)

Responsibilities

Advise 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
Provide 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
Provide legal advice and business counsel relating to clinical trial programs and drug development pathways
Provide legal advice, business counsel and training 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
Provide legal advice, business counsel and training to the Market Access team, including advice on developing and implementing payer strategies, complying with government pricing and state pricing laws, pre-approval information exchange materials, distribution models and materials, patient support programs, HEOR studies and communications
Provide legal advice, business counsel and training to the Medical Affairs team on proactive and reactive communications (e.g., 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
Support the creation and execution of successful government affairs strategies by working collaboratively with the head of government affairs on strategic communications and government related initiatives. Review materials for Corporate Affairs (communications) team, including social media posts
Provide legal advice and business counsel to the Regulatory and Drug Safety teams
Support the implementation and maintenance of a robust and effective corporate compliance program such as developing, reviewing, and training on policies, procedures or other compliance materials; monitoring field activities; fostering a strong internal compliance, ethics, and “speak-up” culture
Work closely with other Legal and Compliance department colleagues to provide consistent and efficient legal and compliance support to the Company
Support the creation, review, updating and training of corporate and healthcare compliance policies, SOPs, rules of engagement, and laws, regulations, guidance and codes
Provide and coordinating legal support as a member of cross-functional teams
Represent the Legal department on cross-functional initiatives and collaborating with other members of the Legal department on internal initiatives
Research issues and supporting the company in providing a wide range of legal advice to internal clients
Manage outside counsel resourcing and budget for complex or nuanced areas of law, regulation or policy