Clinical Operations Development Lead
New
Based in United StatesFull-TimeSenior
Salary212,000 - 291,500 USD per year
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Job Details
- Experience
- 10+ years
- Required Skills
- Project ManagementRisk Management
Requirements
- Bachelor’s or advanced degree in life sciences, medicine, pharmacy, biomedical sciences, or related field
- 10+ years of experience in clinical development and/or clinical operations within the pharma or biotech industry
- Expertise in clinical trial design, execution, and management across multiple phases
- Experience with outsourced models and CRO oversight
- Demonstrated experience in developing and executing clinical development strategies
- Strong understanding of ICH-GCP guidelines and global regulatory requirements
- Proven ability to manage complex clinical programs, budgets, timelines, and risks
- Strong leadership, stakeholder management, and cross-functional collaboration skills
- Excellent communication and influence skills
- Strong organizational and analytical skills
Responsibilities
- Co-lead Clinical Development Teams (CDTs) with Medical Development Leads
- Define, develop, and maintain clinical development strategies
- Oversee end-to-end clinical trial planning and execution
- Drive creation and maintenance of the Clinical Development Plan
- Lead cross-functional coordination across clinical operations, medical, regulatory, and biostatistics
- Identify, assess, and mitigate program risks
- Oversee vendor and CRO selection and management
- Ensure inspection readiness and compliance with ICH-GCP
- Provide oversight of clinical trial design and protocol development
- Contribute to governance meetings and executive reporting
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