Sr. Clinical Study Lead
Emeryville, CA /
Clinical /
Full Time
/ On-site
Kyverna is a cell therapy company engineering and developing a new class of curative living medicines for inflammatory and autoimmune diseases. Kyverna is navigating what’s next in the synthetic biology, immunology and cell engineering to create a new class of T-cell therapies programmed to target and selectively modulate the underlying causes of autoimmunity. Join the front lines of a cell therapy revolution where scientists, industry veterans and healthcare visionaries are creating a new class of living medicines for autoimmune disease.
Kyverna is recruiting a highly motivated Clinical Study Lead with Cell Therapy (CAR T) clinical study experience to help advance its mission to free patients from the siege of autoimmune disease. The Clinical Study Lead will be a key member of the Clinical Operations team, leading the successful execution of Kyverna’s clinical trials. 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:
- Responsible for managing all aspects of clinical trial conduct including study start-up, enrollment, study conduct and close-out
- Responsible for effective vendor oversight
- The candidate must be knowledgeable of current ICH GCP guidelines and applicable regulations
- May manage geographical region(s) of assigned clinical studies
- Defines and incorporates CAR T study logistics and study plans to accomplish study objectives
- Independently manage all components of a clinical trial, leading a cross-functional study team. The assigned clinical trial may be of high complexity or high risk.
- Ensure clinical trial activities and deliverables are completed on-time, within budget, and in a highly dynamic and complex environment in accordance with appropriate quality standards including GCP/ICH requirements and Kyverna SOPs.
- Participate in the identification, evaluation, selection, and oversight of clinical trial sites in collaboration with the Clinical Research Organization (CRO)
- Partner efficiently, effectively, and professionally with participating study sites to ensure smooth study conduct.
- Implement strategic operational activities to ensure efficient study enrollment and high-quality monitoring activities at participating clinical sites.
- Review invoices and track study budget according to the forecast, working closely with finance and clinical business operations.
- Manage external vendors with oversight of activities.
- Oversee implementation and maintenance of Trial Master File for inspection readiness.
- Develop study documents and tools including study, informed consent forms, project plans, budgets, study logs, templates, and other materials as needed.
- Collaborate with clinical team and vendors to develop study-specific documents, and maintenance of internal files
Requirements:
- Strong clinical study conduct experience from start-up through close-out, with global trial and CRO management experience highly preferred.
- Strong leadership, effective decision making, and problem-solving skills required.
- Established knowledge of clinical operations.
- Established Cell Therapy /CAR T study experience required.
- Working knowledge of relevant GCPs and FDA/EMA regulations.
- Ability to work effectively with minimal supervision and multi-task activities to effectively manage deliverables across all trials.
- Travel up to 25 % - ability to travel domestically and internationally
- Excellent written and verbal communication skills
- B.S. degree with minimum 6-8 years of experience managing clinical trials in biotech, pharmaceutical, and/or CRO environment.
The salary range for this position is $145,000 USD to $185,000 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 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
