Kyverna Therapeutics is a clinical-stage cell therapy company with the mission of engineering a new class of therapies for autoimmune diseases. The Kyverna therapeutic platform combines advanced T cell engineering and synthetic biology technologies to suppress and eliminate the 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.
Responsibilities:- Responsible for building and managing the Clinical Operations team.
- Provide strategic direction and lead the development and execution of the global clinical operations plan in support of Kyverna's clinical trial programs.
- Lead the end-to-end planning, execution, and close-out of clinical trials of one or more programs in collaboration with the Medical Lead, and internal/CRO's cross-functional teams from conception through final CSR.
- Act as a cross-functional liaison to ensure study plan aligns with business strategies, and is the internal point of contact for resolution of operational issues.
- Manage trial level budget, including forecast and annual cost targets.
- Oversee clinical trial feasibility, agreements, budgets, expenditures, payments, and resource management.
- Create and drive trial level timelines (including patient recruitment plan), and create and execute operational risk management and mitigation plans.
- Assess and select CRO's in collaboration with internal teams, ensure vendors meet quality standards, and contribute to the development of vendors' contracts.
- Establish and maintain good working relationships with CROs and clinical study site personnel to ensure GxP compliance, adherence to protocols, and provision of quality data in a timely manner.
- Oversee conduct of clinical trials at the study centers (e.g., IRB/EC submissions, site selection, start-up, SIV, monitoring, close-out).
- Contribute to the data review plan and ensure continuous data review and cleaning activities are meeting the quality standards in support of dose-escalation meetings and database lock (in collaboration with data management, clinical scientists and medical leads).
- Ensure Trial Master Files are properly maintained.
- Forecast and manage, along with manufacture, supply chain and CRO, the investigational drug supply.
- Contribute, along with relevant functions, to the design and timely implementation of clinical protocols and ICFs, and data collection, quality, and management systems.
- Provide operational and strategic input on training materials, program specific standards, clinical development plans, and clinical sections of regulatory documents (e.g., Investigator Brochure, clinical study reports, safety updates, briefing books, submission dossiers).
- Lead the writing of clinical Standard Operating Procedures and drives clinical operations excellence trough process improvement, lessons learn sharing, and training across clinical trials and programs.
- Ensure clinical trial information and results are reported within the relevant trial repositories and tracking systems (e.g., trial registries).
- Assure that clinical deliverables are completed on time, on budget, and with high quality, ethical and professional standards.
Requirements:- B.A. in life sciences/healthcare is required. Advanced degree is preferred.
- At least 8 years of pharmaceutical/biotech/CRO clinical research operations experience in Phase I-IV studies. Experience in Phase I dose-escalation and adaptive studies desired.
- Experience in clinical studies of immune cell therapy is required and in autoimmune diseases is desirable.
- Working knowledge of GCP/ICH, clinical trial design, regulatory, and clinical development processes.
- Self-starter, with strong ability to communicate and establish effective working relationship with CFTT, CROs, leadership teams, Investigators, and clinical development partners.
- Excellent influencing, negotiation, problem-solving, and project management skills.
- Travel 20% required.
$210,000 - $250,000 a year
The base salary range for Candidates residing in California for this position is $210,000 USD to $250,000 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