Associate Director, Product and Medical Affairs Counsel

Job description

MindMed 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.

Reporting to the Chief Legal Officer, the Associate Director, Product and Medical Affairs Counsel will serve as the lead product counsel for MindMed’s Phase 3 product in development for treatment of Generalized Anxiety Disorder (GAD) and Major Depressive Disorder (MDD) and other pipeline products. This position will support multiple client groups, including teams within MindMed’s Regulatory, Marketing, Patient Services, Market Access, Medical Affairs, and Commercial and Corporate Affairs functions, providing advice on matters related to promotional and educational activities, engagements with healthcare providers and entities, patient advocacy groups, payers and policy decision makes, and other applications of healthcare and regulatory compliance in the biopharmaceutical industry.

The Product and Medical Affairs Counsel also will have a dotted line to the Company’s Associate General Counsels. The Product and Medical Affairs Counsel will assist with reviewing, drafting, negotiating and advising on a variety of contracts and documents.

The Product and Medical Affairs Counsel will provide legal support and advise business stakeholders in all levels of the organization, including senior management, as well as lead and/or play a significant role in special projects and on cross-functional teams dealing with complicated legal and compliance issues. Such issues include the interaction of regulatory requirements, good clinical practices, and drug development requirements, as well as serving as the legal representative in the Medical, Legal and Regulatory (MLR) review process and the Promotional Review process.

This role will also have significant interaction with Regulatory Affairs, Commercial, Corporate Affairs, IT and other functions throughout MindMed. This position requires a problem-solving mindset, a high degree of collaboration with internal clients and colleagues, and the ability to exercise mature and reliable judgment in the company’s fast-paced environment.

The is a remote position, that will require travel approximately once a quarter.

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

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

• Admitted to state bar, NY, MA, PA, NJ or NC State Bar preferred

• 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

• Knowledge and experience with managed markets, payer and PBM contracting, patient support programs and/or government pricing a plus

• 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

The starting base pay range for this position is $179,000.00 - $210,000.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.

Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:

• 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!