Senior Director, Commercialization and Development Counsel

ABOUT US

Invivyd, Inc. (Nasdaq: IVVD) is a commercial-stage company on a mission to rapidly and perpetually deliver antibody-based therapies that protect vulnerable people from the devastating consequences of circulating viral threats, beginning with SARS-CoV-2. The company’s proprietary INVYMAB™ platform approach combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering. INVYMAB is designed to facilitate the rapid, serial generation of new monoclonal antibodies (mAbs) to keep pace with evolving viral threats. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for its first mAb in a planned series of innovative antibody candidates.

THE HEART OF INVIVYD: OUR EMPLOYEES

Our team is motivated by a collective mission-driven sense of urgency that permeates Invivyd’s culture. We make decisions quickly, trust employees in their areas of expertise, and collaborate efficiently. As a result, Invivyd employees are both quick thinkers and motivated doers.

Invivyd is a company comprised of motivated biopharmaceutical experts who are driven to make an impact on public health. Each employee sees working at Invivyd as a once-in-a-lifetime career opportunity to bring differentiated products to the market—for COVID-19, influenza and beyond.  Our company operates as a hybrid company with employees working at our corporate headquarters in Waltham, Massachusetts and remotely. We have employees in over 25 states, with a critical mass in the greater Boston area and many employees in the northeast as well as California.  

Position Title: Senior Director, Commercialization and Development Counsel

Summary:   

The Senior Director, Commercialization and Development Counsel 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.

Reporting to the Chief Legal Officer, this position will be part of a dynamic Legal team.

The ideal candidate is someone who thrives in a fast-paced environment, who is a 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 candidates
• 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 and business counsel relating to clinical trial programs and drug development pathways
• Providing 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
• Providing 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
• Providing 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
• Reviewing materials for Corporate Affairs (communications) team, including social media posts
• Providing 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 and reviewing and training on policies, procedures or other compliance materials; monitoring field activities; foster a strong internal compliance, ethics, and “speak-up” culture
• 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

Requirements:

• Have a 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
• 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

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, 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
• Ability to periodically travel (e.g., to attend company and/or department meetings)

At Invidyd we strive to create a welcoming and inclusive environment.   Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics.

Invivyd is proud to be an equal opportunity employer.