[Hiring] Associate Director, Brand Counsel @Definium Therapeutics

Role Description

The Associate Director, Brand Counsel serves as a strategic legal partner to Commercial, Medical Affairs, Regulatory Affairs, Market Access, Corporate Affairs, and Compliance. This attorney will help shape the legal and regulatory framework supporting the development, and potential launch and commercialization of Definium assets. This role requires expertise in pharmaceutical advertising and promotion, strong business judgment, and the ability to navigate novel legal and policy considerations.

Responsibilities

• Support Commercial and Brand Legal Strategy
  • Act as the legal advisor to brand, marketing, market access, and commercialization teams
  • Partner with cross-functional stakeholders to support launch planning and commercialization strategy
  • Strategically advise teams on legal risks and offer practical solutions related to brand positioning, customer engagement, and commercialization initiatives
  • Support development of a best-in-class commercialization model for innovative psychiatric therapies
• Materials Review
  • Serve as a core member of the Promotional Review Committee (PRC) and Medical Review Committee (MRC)
  • Review and approve promotional materials directed to healthcare professionals, patients, and caregivers
  • Advise on market-shaping activities, disease education communications, provider engagement strategies, and launch materials
  • Counsel teams regarding FDA, the Office of Prescription Drug Promotion (OPDP), Federal Trade Commission (FTC), and federal and state law requirements applicable to pharmaceutical promotion
  • Support legal review of sales training materials, websites and digital assets, print media, speaker program materials, advisory board materials, Medical Affairs materials
  • Help establish promotional review standards, policies, and governance processes for a pre-commercial organization transitioning to launch
• Regulatory & Healthcare Compliance Counseling
  • Advise stakeholders regarding:
    • FDA requirements for promotion and scientific exchange
    • Healthcare fraud and abuse laws
    • Payment transparency and reporting obligations
    • Privacy and data protection requirements, including Controlling the Assault of Non-Solicited Pornography and Marketing Act (CAN-SPAM)
    • Price transparency reporting obligations
    • PhRMA Code compliance
  • Strategically partner with Compliance and Regulatory Affairs on risk assessments and mitigation strategies
  • Monitor emerging legal and regulatory developments affecting psychiatric therapies and novel treatment modalities

Qualifications

• Juris Doctor (J.D.) from an accredited law school.
• Active membership in at least one U.S. state bar.
• Minimum of 5 years of legal experience, including significant pharmaceutical or biotechnology industry experience.
• Demonstrated expertise in FDA-regulated advertising and promotion.
• Experience working within MLR review processes.
• Strong understanding of:
  • FDA and OPDP requirements
  • Healthcare fraud and abuse laws
  • Pharmaceutical compliance frameworks
  • Regulatory review and launch preparation

Requirements

• Experience supporting launch or pre-launch pharmaceutical products.
• Experience in psychiatry, neuroscience, central nervous system (CNS), rare disease, or specialty pharmaceutical products.
• Familiarity with REMS programs, controlled substances.
• Experience supporting Marketing, Market Access, and Medical Affairs.
• Prior experience helping build legal frameworks and governance processes in a growing commercial organization.

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!

Company Description

Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale. Our lead product candidate, lysergide tartrate, represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Guided by the recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address the underlying causes of psychiatric and neurological disorders.