Senior Director, Commercialization and Development Counsel

Role Summary

The Senior Director, Commercialization and Development Counsel will provide legal counsel and business advice to Commercial, Clinical, Medical and Pharmacovigilance leadership and related teams on areas of law, policy, risk, and mitigation strategies, supporting drug development, commercialization and product launches. The role requires significant experience in law and/or biotech/pharma with exposure to drug development and commercialization.

Responsibilities

• Advise on FDA and global regulatory matters, compliance, product development, regulatory submissions, advertising and promotion, and drug safety across the product lifecycle
• Provide legal counsel on health care laws and related obligations (e.g., Anti-Kickback Statute, FDCA, False Claims Act, PhRMA Code, FTC, HIPAA, CAN-SPAM, physician gift laws, Sunshine Act, pricing transparency, product liability)
• Offer legal advice on clinical trials and drug development pathways
• Train and advise Marketing on compliant strategies for advertising, digital and social media, and interactions with healthcare providers
• Advise Market Access on payer strategies, government pricing compliance, pre-approval information exchange, distribution models, patient support programs, HEOR studies
• Support Medical Affairs on communications, publications, engagements, and scientific exchange; participate as Legal representative on select scientific exchange reviews
• Support government affairs strategies in collaboration with the head of government affairs
• Review Corporate Affairs materials, including social media posts
• Advise Regulatory and Drug Safety teams
• Develop and maintain corporate compliance programs; train on policies and procedures; monitor field activities; foster ethics and speak-up culture
• Collaborate with Legal and Compliance colleagues to provide consistent support
• Develop and train on corporate and healthcare compliance policies, SOPs, rules of engagement, and applicable laws
• Provide and coordinate legal support as part of cross-functional teams
• Represent the Legal department on cross-functional initiatives
• Research issues and provide a wide range of legal advice to internal clients
• Manage outside counsel resourcing and budgets for complex areas

Qualifications

• Juris Doctor (J.D.) from an ABA-accredited law school; licensed to practice in the state of residence; ability to obtain in-house counsel registration
• Minimum of 7 years of relevant life sciences experience in a pharmaceutical/biopharma company or related law firm experience
• Significant experience representing Legal on Promotional Review Committee
• Expertise in federal and state laws, regulations, guidelines, and industry codes affecting pharmaceutical manufacturers
• Experience supporting regulatory and commercialization teams; product launch experience strongly preferred; buy-and-bill experience a plus
• Experience supporting regulatory affairs and drug safety
• Knowledge of enforcement landscape, settlements, and corporate integrity obligations
• US employment law experience a plus
• Strong judgment, ethics, accountability, and professional maturity
• Excellent communication and leadership skills; collaborative and capable in a hybrid environment
• Experience with digital and social media policies and industry practice
• Proven ability to be a valued business partner and deliver timely, high-quality work
• Ability to thrive in a fast-paced, evolving environment; growth mindset; team player
• Strong problem-solving, critical thinking, and prioritization abilities
• Commitment to staying current with relevant laws, regulations, and codes; willingness to travel periodically

Skills

• Regulatory affairs and compliance
• Drug labeling, advertising, and promotion
• Scientific exchange and medical communications
• Market access and payer strategy
• Digital and social media governance
• Cross-functional collaboration
• Legal research and risk assessment
• Budget management for outside counsel