Medical Director, Clinical Development (CAR T & Autoimmune) – Remote

Kyverna Therapeutics; United States; Ibrido; USD 330.000 - 370.000; Tempo pieno

Descrizione del lavoro

Kyverna Therapeutics is seeking a Medical Director/Sr. Medical Director, Clinical Development to lead CAR T-cell therapy programs in autoimmune diseases. The role reports to the SVP, Clinical Development & Medical Affairs and combines medical oversight with cross-functional leadership.

The candidate will guide trial design, safety monitoring, regulatory submissions, and collaboration with investigators and CROs, driving strategic execution and scientific excellence across late-stage programs.

Competenze

• MD, DO, (or ex-US equivalent) or MD-PhD degree required.
• 5+ years of clinical research experience with 3+ years of industry experience in late-stage clinical development; experience in designing and executing trials preferred.
• Specialty training in neurology, rheumatology, nephrology, or industry experience in cell therapies/autoimmune diseases preferred.
• Proven ability to interpret, discuss and present efficacy and safety data.
• Strong knowledge of GCP/ICH, trial design, regulatory requirements.
• Strong ability to communicate and establish effective relationships with investigators, CROs, and partners.

Mansioni

• Serve as physician lead for CAR T-cell therapy trials in autoimmune diseases, in partnership with cross-functional teams.
• Oversee medical monitoring of trials, including engagement with site investigators and external monitors.
• Partner with clinical operations, biometrics, regulatory, and commercial teams to align strategy and execution.
• Lead design, execution, and interpretation of trials across assigned program.
• Provide medical input into development plans, study protocols, investigator brochures, and regulatory submissions.
• Medical review and interpretation of safety, efficacy, PK and biomarker data.
• Develop clinical trial documents including protocols, ICFs, development plans, and publications.
• Lead development of regulatory sections (IB, safety updates, CSRs) and responses to Health Authorities.
• Engage with external investigators and researchers to identify and support investigator-sponsored studies.

Formazione

MD/DO/MD-PhD

Specialty training in neurology/rheumatology/nephrology

Descrizione del lavoro

Kyverna Therapeutics is seeking a Medical Director/Sr. Medical Director, Clinical Development to lead CAR T-cell therapy programs in autoimmune diseases. The role reports to the SVP, Clinical Development & Medical Affairs and combines medical oversight with cross-functional leadership.

The candidate will guide trial design, safety monitoring, regulatory submissions, and collaboration with investigators and CROs, driving strategic execution and scientific excellence across late-stage programs.