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Senior Director, Clinical Science

Role overview

Qualifications

  • Advanced degree (Ph.D., Pharm.D., M.D., or equivalent) in a scientific or life sciences discipline
  • 10+ years of progressive experience in drug development
  • Demonstrated success in developing and executing clinical strategies at a program level
  • Deep understanding of global regulatory frameworks and clinical development pathways

Responsibilities

  • Serve as the senior clinical scientist for CAR T-cell therapy clinical trials
  • Partner with clinical operations, biometrics, regulatory, and commercial teams
  • Lead design, execution, and interpretation of clinical trials
  • Ensure compliance with GCP, corporate policies, and applicable local regulations

Key facts

  • Remote from: United States
  • Full time
  • Senior (5-10 years)
  • Clinical Research Coordinator
  • 260 - 290K yearly
  • English

Hard skills

Other skills

  • Technical Acumen
  • Communication
  • Management

About the company

Kyverna Therapeutics logo

Kyverna Therapeutics

Biotechnology

Kyverna is a clinical-stage biopharmaceutical company focused on liberating autoimmune patients through the curative potential of cell therapy. Kyverna’s lead autologous CD19-targeting CAR T-cell therapy candidate, miv-cel (mivocabtagene autoleucel, KYV-101), has demonstrated the potential to fundamentally change the treatment paradigm across multiple B-cell-driven autoimmune diseases. Kyverna is advancing its potentially first-in-class neuroimmunology franchise with its recently completed registrational trial in stiff person syndrome and an ongoing registrational trial for generalized myasthenia gravis. The Company is also harnessing other KYSA trials and investigator-initiated trials, including in multiple sclerosis and rheumatoid arthritis, to inform the next priority indications. Additionally, its next generation pipeline includes CAR T-cell therapies deploying novel innovations to improve patient access and experience.

Company details

IndustryBiotechnology
Company size51-200

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Job description

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible.

Title: Senior Director, Clinical Science

Location: Remote or Hybrid

Reports To: SVP, Clinical Development & Medical Affairs


Responsibilities
  • Serve as the senior clinical scientist for CAR T-cell therapy clinical trials in autoimmune disease indications, in partnership with internal and external cross-functional teams
  • Partner with clinical operations, biometrics, regulatory, and commercial teams to ensure alignment on strategy and execution
  • Lead design, execution, and interpretation of clinical trials across assigned program
  • Provide scientific input into clinical development plans, study protocols, investigator brochures, and regulatory submissions.
  • Participate in the development of clinical trial documents including protocols, ICFs, clinical development plans, and publications.
  • Lead the development of clinical sections of regulatory documents including the IB, safety updates, clinical study reports, and responses to Health Authorities in collaboration with the study physician.    
  • Represent Clinical Development for the assigned program with cross-functional leaders
  • Represent Clinical Development for the assigned program with key opinion leaders and strategic partners to inform clinical and scientific strategy
  • Represent Clinical Development for the study team in high-impact external settings (advisory boards, regulatory meetings, major congresses), as appropriate
  • Contribute to external scientific narrative and positioning through publications, presentations, and collaborations.
  • Ensure compliance with GCP, corporate policies, and applicable local regulations.
  • Lead, mentor, and develop high-performing clinical scientists and other staff
  • Foster a culture of innovation, accountability, and scientific rigor.
  • Contribute to Clinical Development organizational design and capability building to support future pipeline growth and complexity.

  • Qualifications
  • Advanced degree (Ph.D., Pharm.D., M.D., or equivalent) in a scientific or life sciences discipline required
  • 10+ years of progressive experience in drug development, including significant experience across multiple programs, including late-stage global clinical trials
  • Demonstrated success in developing and executing clinical strategies at a program level
  • Experience in late-stage clinical trials required
  • Experience in cell and gene therapy, immunology, autoimmune disease, or related fields strongly preferred
  • Deep understanding of global regulatory frameworks and clinical development pathways required
  • Strong operational acumen with excellence and efficiency
  • Exceptional communication and management skills
  • Ability to operate independently and effectively in a fast-paced, highly dynamic environment
  • Ability to travel up to 15% of the time
  • The national salary range for this position is $260K to $290K USD annually. This salary range is an estimate of what we reasonably expect to pay for this position, and the actual salary may vary based on factors including experience, education, geographic location, internal equity, and market data. This position is also eligible for annual bonus, equity, benefits, and participation in the Company’s stock plan. 

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    MR

    Marcus Rivera

    Chief Revenue Officer

    m.rivera@company.com
    linkedin.com/in/marcusrivera
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