Senior Director, Commercialization and Development Counsel

Role 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

• 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

Qualifications

• 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 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
• 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
• 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
• Exceptional judgment, self-management, ethics and maturity; strong sense of accountability and ownership
• Strong interpersonal relations, teamwork, and ability to collaborate across functions
• Ability to think critically, articulate risk, and provide compliant, practical solutions
• Excellent verbal and written communication; strong leadership skills
• Experience with digital and social media policies, regulations, guidance and industry practice
• Demonstrated ability to be a valued business partner
• Ability to multi-task and deliver high-quality work in a fast-paced environment
• Collaborative, able to work independently in a hybrid environment; positive, growth mindset
• Interest and ability to learn the business and build client relationships to deliver results
• Team player willing to support the legal team and broader initiatives
• Strong problem-solving and decision-making skills with creative, implementable solutions
• Commitment to staying current with laws, regulations, guidance, policies and codes to mitigate risk
• Ability to periodically travel to attend company and/or department meetings

Education

• Juris Doctor (J.D.) from an ABA-accredited law school