远程工作雷达

高级总监,临床科学

Senior Director, Clinical Science

其他限定地区(需当地身份)
公司Kyverna
薪资$260,000 - $290,000/年
工作地点United States
地域资格限定地区(需当地身份)
时区要求日间重叠约 9 小时,基本正常作息
用工类型Full Time
发布时间今天
数据来源Himalayas
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注意地域限制:该职位明确限定在 United States 招聘。如果你是位于中国大陆的求职者,通常需要当地工作身份才能投递,或需与雇主确认是否接受独立合同(Contractor)形式合作。

Kyverna Therapeutics 是一家以患者为中心的临床阶段生物制药公司,致力于开发针对自身免疫疾病患者的细胞疗法。在我们核心价值观的指引下——坚持初心、协作加速、清晰领导、大胆创新、承担责任,我们致力于改变自身免疫疾病治疗的未来。加入我们,站在细胞疗法创新的最前沿,帮助重新定义可能。

职位名称:高级临床科学总监

工作地点:远程或混合办公

汇报对象:临床开发与医学事务副总裁

职责

  • 作为CAR T细胞疗法在自身免疫疾病适应症中的高级临床科学家,与内部和外部跨职能团队合作
  • 与临床运营、统计、监管和商业团队合作,确保策略和执行的一致性
  • 领导所负责项目的临床试验设计、执行和解读
  • 为临床开发计划、研究方案、研究者手册和监管提交提供科学意见
  • 参与临床试验文件的开发,包括方案、知情同意书、临床开发计划和出版物
  • 在研究医生的协作下,领导监管文件中临床部分的开发,包括研究者手册、安全更新、临床研究报告和对卫生当局的回复
  • 代表临床开发部门与跨职能领导就所负责项目进行沟通
  • 代表临床开发部门与关键意见领袖和战略合作伙伴沟通,以指导临床和科学策略
  • 在适当的场合,代表临床开发部门在高影响力的外部环境中(如顾问委员会、监管会议、大型会议)与研究团队进行交流
  • 通过出版物、演讲和合作,为外部科学叙事和定位做出贡献
  • 确保符合GCP、公司政策和适用的当地法规
  • 领导、指导和发展高效能的临床科学家和其他员工
  • 培养创新、问责和科学严谨的文化
  • 为支持未来管线增长和复杂性的临床开发组织架构和能力建设做出贡献

任职要求

  • 需要获得科学或生命科学领域的高级学位(博士、药学博士、医学博士或同等学历)
  • 10年以上相关经验
查看英文原文

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.
Originally posted on Himalayas

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