Description:
Kyverna is seeking a Commercial Corporate Counsel who will serve as a key legal partner to the commercial, medical affairs, and business development functions. This role will provide hands-on legal support across a wide scope, including commercial transactions, commercial site activation, compliance, and launch readiness, while navigating the complex regulatory and compliance landscape unique to a cell therapy company. The ideal candidate is pragmatic, collaborative, and comfortable operating in a lean biotech setting, with the ability to balance strategic thinking and detailed execution.Title: Director, Corporate Counsel - Commercial
Reports to: Executive Director, Associate General Counsel
Location: Remote
Responsibilities:
- Draft, review, and negotiate a broad range of commercial agreements, including:
- Commercial site agreements
- Vendor and supplier agreements
- Distribution, logistics, and manufacturing support agreements
- Consulting, advisory board, patient advocacy and speaker agreements
- Overflow support for clinical, research, and medical affairs-related contracts and confidentiality agreements
- Provide legal guidance to commercialization team including marketing, market access, commercial operations, patient advocacy and medical affairs teams on promotional activities, disease education, and engagement with healthcare professionals.
- Provide legal guidance on go-to-market strategies for a first-in-class or novel cell therapy.
- Support legal aspects of sales, distribution, and commercialization models.
- Advise on pricing, contracting, and reimbursement-related legal considerations in coordination with internal stakeholders.
- Review and advise on promotional materials and commercial communications in coordination with medical and regulatory teams.
- FDA/EMA (including promotional and labeling requirements) and FTC regulations
- Anti-Kickback Statute (AKS), False Claims Act (FCA), and other applicable anti-kickback, anti-corruption, and fraud and abuse laws
- Sunshine Act and other transparency and reporting obligations (e.g., EU disclosure rules)
- PhRMA Code and applicable state laws
- Provide guidance on data privacy and protection matters, including HIPAA and GDPR, particularly in relation to:
- Patient support programs
- Registries and real-world evidence initiatives
- Data-sharing and vendor agreements
Identify legal and business risks and propose practical, compliant solutions aligned with company objectives.
Collaborate closely with internal stakeholders to streamline contracting processes and improve operational efficiency.
Qualifications:
- Juris Doctor (JD) from an accredited law school
- Active license to practice law in at least one U.S. jurisdiction
- 10+ years of relevant legal experience, including in an in-house legal department in the biotech, pharmaceutical, or life sciences industry, with preference given to in-house experience at a cell therapy company, or law firm experience advising life sciences clients on commercial and transactional matters.
- Experience supporting commercialization or launch activities strongly preferred, including experience drafting and negotiating complex commercial contracts including site agreements.
- Familiarity with healthcare, pharmaceutical, biotech, or life sciences regulatory frameworks.
- Knowledge of FDA promotional rules and healthcare compliance requirements.
- Understanding of compliance risks in rare disease and specialty therapeutics.
- Ability to translate complex scientific and regulatory concepts into practical legal advice.
- Ability to balance legal risk with business needs in a high-growth environment.
- Strong business judgment and risk-based decision making, in particular, strong judgment in ambiguous or novel situations, particularly common in cell therapy development.
- Excellent written and verbal communication skills.
- Ability to manage multiple priorities in a fast-paced setting.
- Collaborative mindset with a proactive, solutions-oriented approach, with ability to operate independently with minimal oversight in a small company setting.
- High ethical standards and attention to detail.
