Medical Director/Sr. Medical Director, Clinical Development
At a glance
Director-level role at Kyverna Therapeutics. Remote, United States · full-time · $330,000–$370,000 base.
remoteroles summary, based on the employer's posting.
What you'll do
- Lead CAR T-cell trials for autoimmune conditions, coordinating medical direction with internal teams and outside partners
- Monitor trial safety and progress, working with site investigators and external medical monitors
- Shape trial plans and protocols, then oversee study delivery and interpret the resulting data
- Review safety, efficacy, pharmacokinetic and biomarker findings to guide clinical development
- Prepare clinical and regulatory materials, including study reports, safety updates and health-authority responses
What you bring
- An MD, DO, MD-PhD or equivalent medical qualification is required
- At least five years in clinical research, including three or more in industry late-stage development and trial design
- You can assess and present safety and efficacy results, with strong command of GCP/ICH and clinical trial design
- You can build effective working relationships with investigators, scientific advisers, CROs and other partners
Who this fits
This remote or hybrid director-level role suits a physician with industry experience who has led later-stage clinical trials. Specialty training in neurology, rheumatology or nephrology, or experience with cell therapies or autoimmune treatments, is preferred.
From the employer
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 $330,000 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 plan.