Senior Director, Commercialization and Development Counsel

Position 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 decision makers 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, is a strategic problem solver, and 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
• Supporting 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.
• Reviewing materials for Corporate Affairs (communications) team, including social media posts
• Providing legal advice and business counsel to the Regulatory and Drug Safety teams
• Supporting 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…