Sr. Clinical Trial Manager
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 Senior Clinical Trial Manager (Sr CTM) will lead the operational delivery of one or more cell therapy clinical trials from study design through close-out. Sr. CTM will be accountable for timelines, budget, quality, vendor & CRO oversight, and cross-functional coordination for the assigned studies. Given the complexity of cell therapies (manufacturing, specialized logistics, regulatory, unique site burden), this role requires deep knowledge of clinical operations plus specific experience in cellular therapies or advanced biologics.
Title: Sr. CTM
Location: Remote
Reports to: Sr. Director, Clinical Operations
Responsibilities
- Lead and manage the day-to-day operational execution of assigned cell therapy trials: study startup, site activation, enrollment, monitoring, close-out.
- Develop and manage study timelines, budgets, forecasts, and related operational metrics.
- Partner with external vendors / CROs / service providers (monitoring, labs, imaging, manufacturing/supply chain for cell product) to ensure high quality and timely deliverables.
- Serve as the primary cross-functional operational contact for study teams (clinical operations, data management, biostatistics, regulatory, safety/pharmacovigilance, manufacturing, supply chain, medical affairs, quality).
- Ensure compliance with regulatory and quality standards (FDA, EMA, ICH-GCP, relevant local regulations) and internal SOPs.
- Participate in protocol development and amendments, informed consent form (ICF) review, CRF/data tool development, TMF (Trial Master File) setup & maintenance, monitoring plan, data review plan, drug/cell-product accountability and reconciliation.
- Oversee site feasibility, selection, contracting, start‐up (site initiation visits, training, enrollment & retention strategies) and close‐out activities.
- Monitor study progress, identify risks/issues (enrollment delays, monitor/vendor performance, budget overruns, data quality issues) and implement mitigation strategies.
- Foster effective communication across study teams, escalate issues to senior leadership as needed.
- Ensure preparation for audits/inspections, maintain high standards of documentation readiness.
- Contribute to lessons-learned and process improvement initiatives, particularly around cell-therapy-specific operational challenges (e.g., chain of identity/chain of custody, logistics of product, unique site training).
- Review invoices and track study budget according to the forecast, working closely with finance and clinical business operations.
- Develop study documents and tools including study, informed consent forms, project plans, budgets, study templates, and other materials as needed.
Qualifications
- B.S. degree with minimum 7 years of experience in clinical operations including managing clinical trials in biotech, pharmaceutical.
- Strong clinical study conduct experience from start-up through close-out.
- Strong leadership, effective decision making, and problem-solving skills required.
- Established Cell Therapy /CAR T study experience required.
- Working knowledge of relevant GCPs and FDA/EMA regulations.
- Knowledgeable of current ICH GCP guidelines and applicable regulations.
- Ability to work effectively with minimal supervision and multi-task activities to effectively manage deliverables across all trials.
- Experience in small/mid biotechnology environment (startup mindset)
- Excellent written and verbal communication skills
The salary range for this position is from $165,000 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