- 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.
- 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
- 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.
- 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.
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Medical Director, Clinical Development - Emeryville, United States - Kyverna Therapeutics
Description
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases.The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases.
Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated
Kyverna is seeking a highly motivated Medical Director or Senior Medical Director with significant experience in clinical development to join our team developing novel and innovative engineered T cell-based therapies for autoimmune diseases.
The ideal candidate 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.
Responsibilities:
Requirements:
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, relevant experience, tenure, skills and abilities, geographic location, 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.Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.
Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status.
EOE/AA/Vets
