Clinical Development Medical Lead - Internal Medicine (California)

• Responsible for medical and scientific oversight of clinical trials in Internal Medicine
• Provides timely, study-related medical information and guidance
• Conducts and documents periodic safety data review and ongoing clinical/medical data review
• Represents the study team in internal protocol review governance submissions and interactions
• Develops site selection criteria and ensures protocol training is delivered to site-facing colleagues
• Ensures TMF compliance for clinical documents
• Develops clinical guidance and reviews safety data

Requirements

• Primary medical degree (e.g., MD, DO, MBBS, MBChB)
• 4+ years of experience in biopharmaceutical industry in clinical research and development
• Licensed by a licensing body to prescribe medicines for at least 2 years post intern/house officer/foundation period
• Cardiometabolic disease experience preferred
• Clinical research experience in study design, start-up, conduct, and close-out, including regulatory submissions and inspections
• Scientific productivity via publications, posters, abstracts, and/or presentations
• Extensive knowledge of clinical development, global and regional regulation, and ICH/GCP

ATS Optimization Keywords
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Hard Skills

• clinical trials
• safety data review
• clinical research
• study design
• regulatory submissions
• clinical guidance
• protocol training
• TMF compliance
• scientific productivity
• data review

Soft Skills

• medical oversight
• communication
• team representation
• organizational skills
• interpersonal skills

Certifications & Qualifications

• MD
• DO
• MBBS
• MBChB
• licensed prescriber