Associate Director, Brand Counsel

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $175k - $220k / year

⏰ Full Time

🟠 Senior

💃 Brand Manager

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Logo of Definium Therapeutics

Definium Therapeutics

51 - 200 employees

Founded 2019

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Definium Therapeutics is a clinical-stage biotechnology company developing precision psychedelic-derived therapeutics for psychiatric and neurodevelopmental disorders. The company focuses on pharmaceutically optimized formulations of lysergide (LSD) and an R-enantiomer of MDMA to treat conditions such as major depressive disorder, generalized anxiety disorder, and core symptoms of autism spectrum disorder, advancing candidates through preclinical and clinical trials with a science-led, evidence-backed approach.

📋 Description

• Serve as a strategic legal partner to Commercial, Medical Affairs, Regulatory Affairs, Market Access, Corporate Affairs, and Compliance • Act as legal advisor to brand, marketing, market access, and commercialization teams • Partner with cross-functional stakeholders on launch planning and commercialization strategy • Advise on legal risks and practical solutions for brand positioning, customer engagement, and commercialization initiatives • Support development of a commercialization model for innovative psychiatric therapies • Serve on the Promotional Review Committee and Medical Review Committee • Review and approve promotional materials for healthcare professionals, patients, and caregivers • Advise on market-shaping activities, disease education communications, provider engagement strategies, and launch materials • Counsel teams on FDA, OPDP, FTC, and federal and state pharmaceutical promotion requirements • Review sales training materials, websites, digital assets, print media, speaker program materials, advisory board materials, and Medical Affairs materials • Help establish promotional review standards, policies, and governance processes • Advise on FDA promotion and scientific exchange requirements, healthcare fraud and abuse laws, payment transparency, privacy and data protection, CAN-SPAM, price transparency, and PhRMA Code compliance • 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

🎯 Requirements

• 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

🏖️ 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 • Fun fringe perks • Additional compensation may include bonus and equity

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