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
The Associate Director, Clinical Operations will manage clinical trials in coordination with a clinical operations team. This individual will be involved in the daily operations of Kyverna’s clinical programs through vendors. This person may lead a team of clinical operations professionals and will be expected to provide vision, leadership, and mentoring to their assigned team. He or she must have an expert and comprehensive understanding of ICH/GCP requirements, principles, concepts, industry practices, and standards. Under the direction of a senior clinical operations person, this individual is responsible for clinical trial management through CROs, oversight and successful execution of Kyverna’s clinical trials according to regulatory guidelines. He or she must facilitate effective internal and external relationships. This person is also responsible for the achievement of project goals and objectives on time and on budget. The position will have some travel requirements. The candidate will be expected to contribute to Investigator Meetings, site relationships and vendor management which may include face-to-face interaction
Responsibilities
- Manage complex Phase 1, 2, 3, and 4 clinical trials as part of a small operational team
- Demonstrate oversight of vendors and work in a quality framework that supports early and late development work
- Responsible for vendor management activities including attendance and input at team meetings and tracking and follow up on action items.
- Lead study start up process and cross functional planning in support of study start up
- Provide review and input on clinical documents (protocols, informed consent documents, monitoring plans, clinical trials report, investigator brochures, etc.)
- Conduct feasibility and site selection
- Coordinate closely with Clinical Development, Biostatistics, Data Management, Drug Safety, Legal, Finance, Project Management and Regulatory to ensure operational excellence.
- Prepare clinical research budgets and timelines
- Analyze and develop action plans to address issues with investigational sites, CRAs, and CROs
Requirements
- Strong knowledge in the areas of drug development, operations, and strategic planning, specifically management of clinical trial operations
- Demonstrated experience in study start up and vendor oversight
- Experience with rare disease clinical trials a plus
- Demonstrated knowledge of international clinical pharmaceutical standards, ICH/GCP guidelines, and regulatory compliance
- International experience is highly preferred
- Must have experience managing CROs, central laboratories, and other clinical study vendors
- Must have a working knowledge of data management, data review and analysis, and drug safety and Pharmacovigilance
- Ability to work on and solve complex problems
- Ability to prioritize and handle multiple tasks simultaneously
- Excellent communication/interaction skills and experience in a dynamic, small organization
The salary range for candidates residing in California for this position is $185,000 USD to $210,000 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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Last updated on Oct 11, 2024