Medical Director/Sr. Medical Director, Clinical Development

Kyverna Therapeutics, Inc.; Northern (KY); Presencial; USD 33.000 - 370.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Bonus

Stock plan

Benefits

Descripción de la vacante

Kyverna Therapeutics is seeking a Medical Director/Sr. Medical Director for Clinical Development. The role is remote or hybrid, reporting to the SVP of Clinical Development & Medical Affairs.

You will lead physician oversight of CAR T-cell therapy trials in autoimmune indications and drive global regulatory and publication activities. The ideal candidate has an MD/DO/MD-PhD with 5+ years of clinical research in late-phase development and strong GCP/ICH knowledge.

Formación

• MD, DO, or MD-PhD required.
• 5+ years clinical research with 3+ years industry in late-phase trials.
• Specialty training in neurology, rheumatology, nephrology or related cell therapies preferred.
• Ability to interpret and present efficacy and safety data.
• Strong knowledge of GCP/ICH, trial design, regulatory requirements.
• Excellent communication with investigators, CROs, and partners.

Responsabilidades

• Serve as physician lead for CAR T-cell therapy trials in autoimmune diseases.
• Oversee medical monitoring of trials and engagement with sites and external monitors.
• Collaborate with clinical operations, biometrics, regulatory, and commercial teams.
• Lead design, execution, and interpretation of trials across the program.
• Provide medical input into CD plans, study protocols, and regulatory submissions.
• Review and interpret safety, efficacy, PK and biomarker data.
• Develop clinical trial documents (protocols, ICFs, CDPs, publications).
• Lead development of regulatory sections (IB, safety updates, CSRs, responses).
• Engage with external investigators to identify and support investigator-sponsored studies.

Conocimientos

GCP/ICH knowledge

Clinical trial design

Regulatory requirements

Stakeholder communication

Educación

MD/DO/MD-PhD

Late-stage clinical development

Descripción del empleo

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible.

Title: Medical Director/Sr. Medical Director, Clinical Development

Location:Remote or Hybrid

Reports To:SVP, Clinical Development & Medical Affairs

Responsibilities

• Serve as the physician lead for CAR T-cell therapy clinical trials in autoimmune disease indications, in partnership with internal and external cross-functional teams.
• Oversee medical monitoring of clinical trials, including engagement with site investigators and external medical monitors.
• 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.

Qualifications

• 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 phase clinical development involved in the design and execution of clinical trials. Experience in late-stage clinical development preferred.
• Specialty training in neurology, rheumatology, nephrology and/or industry experience in clinical development of cell therapies and/or therapies for autoimmune diseases is highly preferred.
• Proven ability to interpret, discuss and present efficacy and safety data.
• Strong 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 is from $33000 to 370000 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 plan.