Associate Director, Product and Medical Affairs Counsel

Summary

Join MindMed, a clinical-stage biopharmaceutical company, as the Associate Director, Product and Medical Affairs Counsel. Reporting to the Chief Legal Officer, you will serve as lead product counsel for MindMed’s Phase 3 product and other pipeline products, providing legal advice and support to multiple teams. You will review, draft, and negotiate contracts and documents, and provide legal support to all levels of the organization. This remote position requires approximately quarterly travel. The role involves significant interaction with various internal functions and external stakeholders. You will play a key role in ensuring compliance with healthcare laws and regulations, and contribute to the company's robust healthcare compliance program.

Requirements

• Strong sense of integrity, business transaction transparency and the ability to balance business interests with the need to exercise independent judgment
• Experience developing HCP interactions with medical affairs and other cross functional stakeholders
• Proven capacity to cultivate strong client relationships and successfully influence leadership in a dynamic, innovative business climate
• Juris Doctorate degree required, and 5+ years of professional work experience at a law firm or in-house legal department with a minimum of 3+ years as in-house counsel (pharma/biotech preferred) with experience in regulatory law and commercial-related matters
• A thorough understanding of regulatory and legal frameworks governing the sales and marketing of approved medicines, and development of investigational medicines; experience understanding complex regulatory guidelines between Medical Affairs and Commercial
• Experience conducting legal review of materials submitted for Promotional Review and MLR review
• Knowledge of laws, regulations, and industry guidance that affect the pharmaceutical industry including Food, Drug & Cosmetic Act, FDA guidance, privacy regulations (e.g., HIPAA, GDPR), fraud and abuse and anti-kickback statutes, OIG and PhRMA guidelines and state marketing compliance laws
• Ability to work independently and in a fast-paced environment and handle multiple complex and confidential tasks
• Ability to analyze and interpret technical procedures, government regulations and legal documents
• Excellent communication and interpersonal skills
• Exceptional attention to detail and deadlines

Responsibilities

• Provide advice, guidance and counsel to commercial, medical and corporate teams on sales and marketing, public relations strategies, programs, policies, practices and initiatives with respect to compliance with relevant U.S. healthcare laws, guidance documents or opinions, and industry codes (Food, Drug & Cosmetic Act, FDA guidance, Office of Prescription Drug Promotion (OPDP), fraud and abuse laws, anti-kickback statutes, federal and state transparency laws, OIG Advisory Opinions, PhRMA Code, etc.)
• Provide legal advice and conduct review of commercial team initiatives supporting commercial expansion upon completion of Phase 3 trials related to MindMed’s MM120 product in development for treatment of GAD and MDD with a primary focus on potential legal issues related to government pricing and price reporting, advertising and promotional regulations, FD&CA, and anti-kickback statute
• Serve as the legal representative in cross-functional Promotional and Scientific Review processes (including PRC, MLR, HCEI and PIE reviews) to provide legal feedback and direction on medical affairs, advertising, public relations, promotional and educational materials, and external communications submitted for review; including the development and/or support of the development of related relevant SOPs
• Advising regulatory, medical affairs, and other internal stakeholders on FDA regulatory submissions, label negotiations and privacy and data use
• Support medical and commercial development for assigned products, including regulatory, medical and marketing strategies, product safety, product liability analyses and risk-mitigation activities and label development
• Review, collaborate and/or provide legal guidance on financial and other interactions with healthcare professionals, patients, or others in a position to influence healthcare decisions (e.g., media, payers, advocacy groups, distributors, etc.) to ensure compliance with applicable laws and regulations
• Support execution of a robust healthcare compliance program, including creation and enforcement of company policies and procedures, risk assessments and ongoing monitoring
• Provide legal and compliance training to MindMed personnel and external consultants, including large group public speaking
• Proactively identify risks, opportunities, and mitigating actions, and collaborate across business functions
• Partner with the Legal and Compliance teams to implement an effective ethics and compliance program
• Stay informed of new laws, regulations, and industry trends affecting the company, and assist with development of policies and training as needed
• Engage and efficiently manage external counsel as appropriate

Preferred Qualifications

• Admitted to state bar, NY, MA, PA, NJ or NC State Bar preferred
• Knowledge and experience with managed markets, payer and PBM contracting, patient support programs and/or government pricing a plus

Benefits

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match and immediate vesting
• Flexible time off
• Generous parental leave and some fun fringe perks!