Remote Sr. Medical Director

Summary

The job is for a Medical Director or Senior Medical Director at Kyverna Therapeutics, a patient-centered biopharmaceutical company developing cell therapies for autoimmune diseases. The role involves leading clinical trials, transitioning preclinical projects to clinical development, and contributing to the goals of the company.

Requirements

• MD (or ex-US equivalent) or MD-PhD degree required. Advanced degree or research experience in immunology preferred
• 5+ years of clinical research experience with 2+ years of industry experience in clinical development involved in the design and execution of clinical trials
• Experience in early clinical development and translational medicine preferred
• Specialty training in rheumatology and/or industry experience in clinical development of therapeutics in autoimmune diseases
• 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

Responsibilities

• Serve as the medical lead for CAR T-cell therapy clinical trials in multiple autoimmune disease indications
• Support the transition of preclinical projects to clinical development
• As the clinical trial study physician, be responsible for clinical deliverables and activities, including medical monitoring of clinical trials, medical review, analysis, and interpretation of safety, efficacy, and PK and biomarker data
• Develop 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

Benefits

$296,000 - $367,000 a year base salary (for California residents), eligible for bonus, benefits, and participation in Company’s stock option plan