Senior Director, Clinical Scientist

🕒 May 18

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Kyverna Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $85M Series B on 2022-01

Biotechnology • Pharmaceuticals • Science

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The company is pioneering CAR T-cell therapies, leveraging the transformational power of T cells to potentially provide sustained, treatment-free remission for autoimmune conditions. Kyverna's lead CAR T-cell therapy candidate, KYV-101, is advancing through clinical trials targeting various autoimmune diseases, including multiple sclerosis, myasthenia gravis, systemic sclerosis, and lupus nephritis. Their pipeline features innovative chimeric antigen receptor (CAR) T-cell therapies in both autologous and allogeneic formats aimed at B cell-driven autoimmune diseases.

📋 Description

• Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. • Lead the scientific and operational execution of clinical programs focused on Multiple Sclerosis. • Develop, lead, and maintain study protocols, informed consent forms, clinical study reports, and other key study documents. • Mentor and potentially manage Clinical Research Scientists. • Partner with Clinical Operations, Biometrics, Regulatory, Medical Affairs, and Commercial teams to ensure alignment on clinical strategy and execution. • Write and review scientific content of key clinical and regulatory documents. • Review and interpret safety, efficacy, MRI/imaging, biomarker, laboratory, relapse, and disability progression data throughout study conduct. • Collaborate with CROs and vendors to ensure high-quality study execution, enrollment performance, operational excellence, and inspection readiness. • Support the monitoring of patient safety during study conduct and appropriate tracking, escalation, and follow-up of adverse events and protocol deviations. • Represent Clinical Development in high-impact external settings including advisory boards, regulatory meetings, investigator meetings, and scientific congresses.

🎯 Requirements

• Advanced scientific or clinical degree required (PhD, PharmD, MD or equivalent). • 10+ years of progressive experience in clinical research, clinical development, and global late-stage clinical trial management within biotechnology or pharmaceutical industries. • Significant experience supporting or leading Multiple Sclerosis clinical development programs required. • Experience in cell therapy, gene therapy, immunology, autoimmune disease, or related therapeutic areas strongly preferred. • Deep understanding of neuroimmunology, autoimmune disease biology, MS clinical endpoints, biomarkers, imaging, and treatment landscape. • Demonstrated success 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 methodology. • Strong operational acumen with the ability to independently lead complex projects in fast-paced, highly matrixed organizations. • Experience interpreting complex clinical datasets, including safety, efficacy, biomarker, laboratory, and imaging data. • Experience with investigator-initiated and/or collaborative research trials preferred. • Prior management experience strongly preferred. • Excellent verbal, written, presentation, and interpersonal communication skills. • Proven ability to support strong relationships with internal stakeholders, external investigators, KOLs, regulators, and scientific collaborators. • Experience working in fast-paced and evolving biotech environments preferred. • Willingness and flexibility to travel up to 15% for congresses, investigator meetings, advisory boards, and clinical site visits as needed.

🏖️ Benefits

• annual bonus • equity • benefits • participation in the Company’s stock plan