Senior Medical Director, Clinical Development

Kyverna is seeking a highly experienced and strategic Senior Medical Director to join our clinical development team. The Sr. Medical Director will provide medical leadership and oversight for clinical programs. The Senior Medical Director will contribute to our goals of navigating what’s next in synthetic biology, immunology and cell engineering while living our core values: Bring Intellectual Rigor, Elevate Each Other, and Stay True To Why.  Title: Senior Medical Director, Clinical Development Location: Remote EligibleReports To:  SVP, Clinical Development & Medical Affairs

Responsibilities:

• Serve as the medical lead for CAR T-cell therapy clinical trials in multiple autoimmune disease indications, in partnership with internal and external cross-functional teams.
• Support, as the clinical representative, the transition of preclinical projects to clinical development.
• Medical monitoring of clinical trials.
• Partner with clinical operations, biometrics, regulatory, and commercial teams to ensure alignment on strategy and execution.
• Lead design, execution, and interpretation of clinical trials across assigned program
• Provide medical and scientific input into clinical development plans, study protocols, investigator brochures, and regulatory submissions.
• Medical review, analysis, and interpretation of safety, efficacy, and PK and biomarker data.
• Development of clinical trial documents including protocols, ICFs, clinical development plans, and publications.
• Lead the development of clinical sections of regulatory documents including the IB, safety updates, clinical study reports, and responses to Health Authorities.    
• Actively engage with external investigators and researchers to identify, evaluate, and support investigator sponsored studies and drive research collaborations.

Requirements:

• MD (or ex-US equivalent) or MD-PhD degree required. Advanced degree or research experience in immunology preferred.
• 7+ years of clinical research experience with 4+ years of industry experience in late phase clinical development involved in the design and execution of clinical trials. Experience in late clinical development preferred.
• Specialty training in neurology, rheumatology, nephrology and/or industry experience in clinical development of therapeutics in autoimmune diseases is highly preferred.
• Proven ability to interpret, discuss and present efficacy and safety data.
• Working knowledge of GCP/ICH, clinical trial design, clinical development processes, and regulatory requirements.
• Strong ability to communicate and establish effective working relationship with investigators, collaborators, scientific advisors, CROs, and corporate partners.

The salary range for this position in Northern California is from $310,000 to 370,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data.  This position is also eligible for bonus, benefits, and participation in Company’s stock option plan.