Senior Director, Clinical Development

Job Summary

Responsibilities

• Medical Monitoring
• Provides medical input on study and country feasibility, including site feasibility assessments
• Contributes to eCRF design, UAT, and CRF Completion Guidelines as needed
• Conducts ongoing clinical data review and assesses protocol deviations
• Addresses medical queries from sites/IRBs, including eligibility, safety, dose modifications, and adverse event management
• Serves as study medical expert and oversees CRO Medical Monitor activities, including data review and medical guidance (e.g., AE coding)
• Clinical Development Expertise & Strategy
• Leads development and execution of the Clinical Development Plan (CDP), ensuring alignment with protocols and Target Product Profile (TPP)
• Provides medical/scientific leadership for study design, protocol development, and key study-level documents (e.g., CSR, IB, regulatory responses)
• Interprets and presents clinical data to internal and external stakeholders; supports regulatory and safety reporting (e.g., DSUR, PSUR)