Job Description

This director-level position oversees medical monitoring and clinical development activities for an ongoing Phase 3 program at a biopharmaceutical company. The role involves trial execution, safety data review, regulatory documentation, and collaboration with internal teams and external partners. Candidates should bring clinical expertise, strong communication skills, and experience managing complex development programs.

Responsibilities

• Serve as medical monitor for assigned clinical trials, reviewing safety and medical data with CRO partners
• Participate in planning, execution, and evaluation of ongoing clinical trials
• Prepare materials for clinical committees including data monitoring and adjudication committees
• Author and review regulatory submissions and ethics committee documents
• Develop relationships with clinical opinion leaders, investigators, and external consultants

Requirements

• Medical degree (MD, DO) or equivalent clinical qualification
• Experience in clinical development, medical monitoring, or related clinical operations
• Knowledge of regulatory requirements for clinical trials and submissions
• Strong written and verbal communication skills
• Ability to collaborate across internal teams and external partners
• Attention to detail in clinical data review and documentation

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