Medical Director/Sr. Medical Director, Clinical Development

Role Summary

Medical Director/Sr. Medical Director, Clinical Development responsible for guiding the strategy and execution of the ACT-EARLY clinical development program for ATTR prevention, leading trials, and contributing to regulatory submissions, publications, and cross-functional medical monitoring. Serves as a liaison between the company and clinical investigators, establishing relationships with field leaders and driving patient-focused development in a fast-paced, small-company environment.

Responsibilities

• Serve as the primary medical monitor for the ACT-EARLY Study
• Own the medical input and clinical development sections of regulatory documents such as Briefing Documents, NDAs/MAAs, and supplemental registration filings, the annual DSUR, and inquiries from health authorities and ethics committees
• Partner with Patient Safety on pharmacovigilance activities
• Collaborate with ClinOps, Regulatory, and Medical Affairs to build relationships with investigators worldwide
• Ensure cross-functional alignment with Development Operations, Regulatory Affairs, Quality and Compliance, Program Management, Medical Affairs, Commercial, CMC/Drug Supply, DMPK, Legal, Finance, HR, and Administration
• Monitor study progress, ensure proper conduct, lead data review and analyses with Data Management and Biostatistics & Programming teams
• Monitor Study Quality metrics with Clinical Operations and Data Management
• Participate in study team and vendor oversight meetings
• Support Clinical Operations in study execution (e.g., patient recruitment)
• Present study updates, interim results, and final data to internal and external stakeholders
• Ensure compliance with clinical R&D policies and SOPs
• Maintain a patient-focused approach and expertise in developing novel therapeutics
• Lead through influence in a fast-paced, small company environment
• Prioritize tasks, manage time effectively, and meet deadlines with high performance standards
• Demonstrate leadership and collaboration across functions and external vendors
• Possess strong written/oral communication and presentation skills
• Analyze data and develop reports/presentations, contributing to publications and presentations
• Apply critical, strategic, and analytical thinking; continue developing ATTR knowledge

Qualifications

• 3+ years of Clinical Development experience preferred in biopharma-sponsored clinical research or drug development
• MD degree or equivalent; specialty/subspecialty training (e.g., cardiology) preferred
• Remote work capability; comfortable working from home; EST zone preferred
• Facility with technology
• Excellent written and oral communication skills
• Travel ‚Äì 15%

Skills

• Medical monitoring and regulatory documentation
• Cross-functional collaboration and stakeholder management
• Data analysis and scientific reporting
• Strategic thinking and decision-making
• Effective communication and presentation

Education

• MD or equivalent; cardiology or related subspecialty preferred

Additional Requirements

• Remote work readiness with ability to travel as needed