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 recruiting a Senior Medical Director - Clinical Development – IIT in its Clinical-IIT organization to help advance its mission to free patients from the siege of autoimmune disease. 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 - Actively engage with external investigators and researchers to identify, evaluate, and support Investigator Initiated Trials and drive research collaborations
- Serve as the Kyverna medical lead for CAR T-cell therapy in Investigator Initiated Trials in multiple autoimmune disease indications, in partnership with internal and external cross-functional teams.
- In collaboration with existing medical director, work closely with sites treating single, named-patients to ensure completeness of safety and efficacy data reporting.
- Contribute to authoring of manuscripts reporting on clinical experience generated at sites
- In collaboration with internal clinical team and external investigators supports the delivery of clinical trial protocols.
- Work closely with MD, MSL(s) and IIT Clinical Operations representative(s) to support delivery of study-related budget and contracts
- Lead internal medical review, analysis, and interpretation of safety, efficacy, and PK and biomarker data
- Review, IIT clinical trial documents including protocols, ICFs, clinical development plans, and publications.
- Support investigators in medical monitoring
- Lead the internal review of clinical sections of IIT regulatory documents eg IB, safety updates, clinical study reports, and responses to health authorities, as needed.
- Other duties as assigned.
Requirements - MD (highly preferred, or ex-US equivalent) or MD-PhD degree required. Advanced degree or research experience in immunology preferred.
- 7+ years of clinical research experience with 4+ years of industry experience in clinical development involved in the design and execution of clinical trials.
- 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, professional societies and patient advocacy organizations.
$320,000 - $390,000 a year
The salary range for candidates residing in California for this position is $320,000 USD to $390,000 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 geographic location, 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 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
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