Director, Commercial & Medical Legal Counsel

Definium Therapeutics

9d • $217,877 - $260,733

About The Position

Definium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health.
Founded in 2019, we are continuously expanding our presence and global footprint. We are constantly searching for high-impact individuals in various clinical, technical and business operations domains to strengthen our team of patient-centric, intelligent individuals.
The Commercial & Medical Counsel will act as a strategic partner to commercial and medical affairs teams, helping translate complex regulatory requirements into practical guidance that enables compliant commercialization. We are looking for a personable legal advisor with an understanding of the False Claims Act; Food, Drug & Cosmetic Act; Anti-Kickback Statute; and other healthcare laws and regulations. You will have high visibility throughout the organization, supporting core business activities and providing counsel to cross-functional teams. You will be empowered to develop strong and positive working relationships with colleagues at all levels. Experience in pharmaceutical / life sciences advising, ability to work in a fast-paced environment, and willingness to be a flexible, business-oriented team player are required. The role reports to the Associate General Counsel.

Requirements

• Juris Doctorate and admission to practice law in at least one state
• Minimum 5 years legal experience, including experience advising pharmaceutical or other life sciences clients is required. In-house pharmaceutical industry experience is preferred
• Understanding of applicable laws and regulations, particularly FDA promotional guidance, the Anti-Kickback Statute and False Claims Act, the PhRMA Code, and relevant HHS-OIG guidance
• Strong interpersonal skills and ability to present complex information accurately and concisely to influence others at all levels of management
• Ability to provide clear, actionable guidance in a fast-paced environment and handle multiple, conflicting priorities and time-sensitive situations
• High degree of professional ethics and integrity

Nice To Haves

• Experience with state price reporting, transparency reporting or privacy matters preferred

Responsibilities

• Provide day-to-day legal counsel to Sales, Marketing, Market Access, Medical Affairs, HEOR and Patient Advocacy teams, advising on a broad range of regulatory matters, including labeling discussions, advertising and promotion, drug safety, market research, scientific exchange, and interactions with healthcare professionals and patients
• Participate as a core member of promotional and medical MLR Review Committees, and advise on advertising, promotion, and scientific exchange
• Advise on interactions with healthcare professionals, payers, patients, and patient advocacy organizations, and help identify and mitigate compliance risks
• Review and/or draft contracts for compliance with relevant regulatory standards
• Ensure compliance with all relevant laws, regulations, policies, procedure and controls within relevant business areas supported
• Develop and deliver training for business partners on legal and compliance issues
• Communicate legal advice to business stakeholders in an authentic and understandable way

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree