Senior Director, Clinical Scientist

This is a fully remote position, open to applicants in United States.

📋 Description

• Kyverna Therapeutics is a clinical-stage biopharmaceutical company focused on patient-centered approaches, developing cell therapies for individuals affected by autoimmune diseases.

• Oversee the scientific and operational implementation of clinical programs targeting Multiple Sclerosis.

• Create, oversee, and maintain study protocols, informed consent documents, clinical study reports, and other essential study-related documentation.

• Provide mentorship and potentially manage Clinical Research Scientists.

• Collaborate with Clinical Operations, Biometrics, Regulatory, Medical Affairs, and Commercial teams to ensure cohesion in clinical strategy and implementation.

• Draft and review the scientific content of critical clinical and regulatory documents.

• Analyze and interpret safety, efficacy, MRI/imaging, biomarker, laboratory, relapse, and disability progression data during the study execution.

• Work alongside CROs and vendors to guarantee high-quality study implementation, enrollment effectiveness, operational excellence, and readiness for inspections.

• Assist in monitoring patient safety throughout the study, including proper tracking, escalation, and follow-up regarding adverse events and protocol deviations.

• Represent Clinical Development at significant external events such as advisory boards, regulatory meetings, investigator meetings, and scientific congresses.

⛳️ Requirements

• An advanced scientific or clinical degree is required (PhD, PharmD, MD, or equivalent).

• A minimum of 10 years of progressive experience in clinical research, clinical development, and management of global late-stage clinical trials within the biotechnology or pharmaceutical sectors.

• Substantial experience in supporting or leading clinical development programs for Multiple Sclerosis is mandatory.

• Experience in cell therapy, gene therapy, immunology, autoimmune diseases, or similar therapeutic fields is highly preferred.

• A thorough understanding of neuroimmunology, autoimmune disease biology, MS clinical endpoints, biomarkers, imaging, and the treatment landscape is essential.

• Proven success in developing and executing clinical strategies across multiple programs, including late-stage global clinical trials.

• Strong knowledge of GCP, ICH guidelines, global regulatory frameworks, regulatory requirements, and clinical trial methodologies.

• Excellent operational acumen with the capability to independently manage complex projects in fast-paced, highly matrixed environments.

• Experience in interpreting complex clinical datasets, including safety, efficacy, biomarker, laboratory, and imaging data.

• Experience with investigator-initiated and/or collaborative research trials is preferred.

• Prior management experience is strongly preferred.

• Exceptional verbal, written, presentation, and interpersonal communication skills.

• Proven ability to foster strong relationships with internal stakeholders, external investigators, KOLs, regulators, and scientific collaborators.

• Experience in dynamic and fast-paced biotech settings is preferred.

• Willingness and flexibility to travel up to 15% for congresses, investigator meetings, advisory boards, and clinical site visits when necessary.

🏝️ Benefits

• Annual bonus

• Equity

• Comprehensive benefits

• Participation in the Company’s stock plan