Senior Medical Director, Clinical Development Lead

Kite Pharma, Inc.; El Segundo (CA); Presencial; USD 275.000 - 355.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Discretionary bonus

Stock options

Health insurance

Paid time off

Life insurance

Descripción de la vacante

Kite Pharma, Inc. seeks a Senior Medical Director to provide clinical oversight to one or more clinical trials and guide teams in designing and implementing high-quality studies within regulatory and budget constraints.

The role involves writing protocols and reports, leading investigator meetings, and translating research findings into development opportunities while ensuring compliance with regulatory guidelines. This position requires MD/DO and extensive drug development experience.

Formación

• MD/DO degree with 6+ years of clinical research or drug development experience.
• Experience in neurology or neuroimmunology is preferred.
• Board certification/specialization in neurology is desirable.

Responsabilidades

• Provide clinical oversight and medical monitoring to one or more clinical trials.
• Lead project teams to design and implement clinical studies.
• Write protocols, investigator brochures, clinical study reports and review clinical trial documents.
• Conduct investigator meetings and lead site initiation visits with clinical trial investigators.
• Implement drug development plans, develop contingency plans, and meet milestones and budgets.
• Translate findings from research/nonclinical studies into clinical development opportunities.
• Interact with investigators and thought leaders; collaborate with regulatory affairs to ensure compliance.
• Support regulatory filings (BLA, MAA) and respond to inquiries from authorities.

Conocimientos

Clinical oversight

Medical monitoring

Trial design

Regulatory knowledge

Cross-functional leadership

Communication

Educación

MD/DO degree

Descripción del empleo

Kite Pharma, Inc. seeks a Senior Medical Director to provide clinical oversight to one or more clinical trials and guide teams in designing and implementing high-quality studies within regulatory and budget constraints.

The role involves writing protocols and reports, leading investigator meetings, and translating research findings into development opportunities while ensuring compliance with regulatory guidelines. This position requires MD/DO and extensive drug development experience.