
Director, Corporate Counsel – Commercial
Kyverna Therapeutics
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $215,000 - $245,000 per year
Job Level
About the role
- 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
- Develop and maintain contract templates and playbooks to support efficient scaling.
- 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.
- Advise on healthcare compliance matters and regulations impacting commercial activities, including:
- - 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
- Partner with compliance to support training, policies, and internal review processes for commercial and medical materials.
- 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
- Assist with legal due diligence and integration activities related to partnerships or acquisitions.
- 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.
Requirements
- 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.
Benefits
- bonus
- benefits
- participation in Company’s stock option plan
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
contract negotiationcommercial agreementslegal guidancehealthcare complianceFDA regulationsanti-kickback lawsdata privacylegal due diligencecommercialization strategiescomplex commercial contracts
Soft Skills
strong business judgmentrisk-based decision makingexcellent communication skillsability to manage multiple prioritiescollaborative mindsetproactive approachattention to detailability to operate independentlyability to translate complex conceptshigh ethical standards
Certifications
Juris Doctor (JD)active license to practice law