Clinical Development Director

Overview

Provide scientific leadership and direction in clinical development programs. Accountable for the development and finalization of study protocols. Liaise with various leads to evaluate key aspects of the study. Provide scientific oversight of clinical studies. Collaborate to ensure regulatory reporting requirements are met. Work closely with study physicians to monitor safety and benefit/risk.

Responsibilities

• Provide scientific leadership and direction in clinical development programs
• Accountable for the development and finalization of study protocols
• Liaise with various leads to evaluate key aspects of the study
• Provide scientific oversight of clinical studies
• Collaborate to ensure regulatory reporting requirements are met
• Work closely with study physicians to monitor safety and benefit/risk

Qualifications

• B.S. OR Masters OR Ph.D. OR Pharm.D.
• 5 plus years of recent drug development experience in a pharmaceutical industry or CRO environment
• Prior drug development experience in HIV / infectious diseases
• Experience in working with or writing study protocols, informed consent forms and clinical study reports
• Experience with reviewing and interpreting clinical and scientific data
• Experience contributing to end-to-end clinical development strategy
• Experience translating complex study-level issues into broader program-level recommendations
• 5 plus years leading cross-functional teams
• Experience managing multiple programs concurrently

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