Senior Clinical Development Leader, Trials & Strategy

Gilead Sciences Inc.; Thousand Oaks (CA); On-site; USD 275,000 - 355,000; Full time

Job summary

Kite Pharma seeks a Senior Medical Director to provide clinical oversight across one or more trials, guiding teams to design and implement studies of high quality within timelines and budgets. This role interfaces with investigators, regulatory affairs, and cross-functional partners to translate research into development plans.

The position requires MD/DO and 6+ years in clinical research or drug development, with neurology specialization preferred.

Qualifications

• MD/DO with 6+ years of clinical research or drug development experience.
• Board certification/specialization in neurology is preferred.
• Experience designing, implementing and conducting clinical trials in neurological diseases is highly desired.

Responsibilities

• 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 site initiation visits with clinical trial investigators.
• Translate findings from research into clinical development opportunities.
• Interact with clinical investigators and thought leaders.
• Work with regulatory affairs and ensure compliance with external guidelines.
• Collaborate across clinical operations, biomarker specialists, CROs, and regulatory affairs.
• Provide input for regulatory filings (e.g., BLA, MAA) and respond to regulatory inquiries.

Skills

Clinical development strategy

Cross-functional leadership

Leadership

Regulatory affairs coordination

Communication with investigators

Education

MD/DO

Neurology board certification

Job description

Kite Pharma seeks a Senior Medical Director to provide clinical oversight across one or more trials, guiding teams to design and implement studies of high quality within timelines and budgets. This role interfaces with investigators, regulatory affairs, and cross-functional partners to translate research into development plans.

The position requires MD/DO and 6+ years in clinical research or drug development, with neurology specialization preferred.