Description:
How You'll Make a DifferenceAs our Brand Counsel, you'll be the primary legal advisor supporting commercial and medical affairs activities for one or more A Clinical-Stage Biopharmaceutical Company products, including anitocabtagene autoleucel (anito-cel), our lead CAR T-cell therapy candidate for the treatment of patients with relapsed refractory multiple myeloma.
In this role you will provide guidance on legal risks and compliance related to branded prescription drug products, focusing on relevant laws such as the Anti-Kickback Statute, False Claims Act, Food, Drug and Cosmetic Act, FDA advertising and promotional regulations, OIG Guidance, and other applicable legal frameworks. Your work on our brand will help us get our therapy to patients in need.
The “Fine Print” – What You'll Do
- Serve as lead counsel to commercial and medical affairs organizations, advising on a broad range of initiatives, including product launches, pricing and reimbursement, patient advocacy and support programs, field team activities, and engagements with healthcare providers and entities.
- Develop a comprehensive understanding of our business model, relevant disease states, markets, customers, and competitors to align legal support with our objectives.
- Review promotional and medical materials.
- Support contracting activities for commercial and medical affairs teams.
- Provide strategic guidance on interactions with healthcare professionals, institutions, and patients.
- Juris Doctor from an accredited U.S. law school.
- 5+ years' relevant experience, including in-house legal experience in the biotech and/or pharmaceutical industry.
- Licensed and a member in good standing with at least one state bar; registered (or willing to register) with the State Bar of California.
- Direct experience supporting new product launches, including market access strategies and insights and evidence generation.
- Experience in promotional and non-promotional reviews, legal risk management and contract review, drafting and negotiation.
- Ability to be both strategic and tactical depending on business needs
- Exceptional problem-solving skills, business judgment, and ability to think strategically and provide practical, tailored advice.
- Exemplary leadership, collaboration, communication, and interpersonal skills.