Definiumtherapeutics
Associate Director, Brand Counsel
Remote. Posted 23 days ago
The role
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 helps shape the legal and regulatory framework supporting the development, potential launch, and commercialization of Definium assets.
What you will do
- 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
- Advise teams on legal risks and practical solutions for brand positioning and customer engagement
- Serve as a core member of the Promotional Review Committee (PRC) and Medical Review Committee (MRC)
- Review and approve promotional materials for healthcare professionals, patients, and caregivers
- Advise on market-shaping activities, disease education, and provider engagement strategies
- Counsel teams regarding FDA, OPDP, FTC, and federal and state law requirements
- Support legal review of sales training, websites, digital assets, print media, and speaker programs
- Help establish promotional review standards, policies, and governance processes
- Advise stakeholders regarding FDA requirements, healthcare fraud and abuse laws, and privacy requirements
Required 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
- Strong understanding of healthcare fraud and abuse laws
- Strong understanding of pharmaceutical compliance frameworks
- Strong understanding of regulatory review and launch preparation
Nice to have
- 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
- Health insurance
- 401(k) with company match
- Flexible time off
- Additional wellness benefits and perks
About the company
Definium Therapeutics is a late-stage clinical biopharmaceutical company focused on developing treatments for psychiatric and neurological disorders. The company is headquartered in New York and trades on Nasdaq under the symbol DFTX.