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Invivyd · 4 hours ago

Senior Director, Commercialization and Development Counsel

New Haven, CT (Northeast preferred)

Full-time

Hybrid

Director/Executive

7+ years exp

Invivyd, Inc. is dedicated to protecting immunocompromised individuals from serious viral infectious diseases. The Senior Director, Commercialization and Development Counsel will provide legal counsel and business advice to leadership across various teams, focusing on drug development, commercialization, and compliance with relevant laws and regulations.

BiotechnologyPharmaceuticalTherapeutics

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

Qualification

Juris Doctor (J.D.)Pharmaceutical law expertiseRegulatory complianceDrug development experiencePromotional Review CommitteeMedical Affairs supportMarket access strategiesDigital media regulationsCommunicationProblem-solving skillsTeam playerSelf-motivation

Required

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)