Executive Director, Medical Monitor

Summary

Join Generate:Biomedicines as an Executive Director to lead medical monitoring and clinical development for late-stage respiratory programs. You will provide medical leadership for clinical trials, ensuring safety and data integrity. Responsibilities include developing clinical strategies, overseeing protocol development, and leading cross-functional interactions. The ideal candidate is an MD with extensive experience in respiratory medicine and a proven track record in pivotal trials. You will interpret clinical trial data, contribute to reports and publications, and guide interactions with external stakeholders. This role offers the opportunity to shape the future of respiratory medicine in a collaborative and mission-driven environment.

Requirements

• MD (required), board certification in Pulmonology or Internal Medicine preferred
• 10+ years of clinical development experience in the biopharma industry
• Deep expertise in respiratory diseases (asthma, COPD) and late-stage clinical trials
• Demonstrated success in leading pivotal global studies and regulatory interactions
• Strong analytical, communication, and cross-functional leadership skills
• Proven ability to influence internal and external stakeholders, including investigators and health authorities
• MD required; additional scientific training (e.g., fellowship, MPH) a plus

Responsibilities

• Provide medical leadership and monitoring for late-stage clinical trials in respiratory diseases (asthma, COPD)
• Drive development and refinement of Target Product Profiles (TPPs) and clinical development strategies
• Oversee protocol development, study design, medical review of data, and safety monitoring
• Lead cross-functional interactions with Clinical Operations, Regulatory Affairs, Biostatistics, and Pharmacovigilance
• Serve as the primary medical contact for clinical sites, investigators, and regulatory bodies
• Interpret clinical trial data and contribute to study reports, publications, and regulatory filings
• Guide interactions with external stakeholders including KOLs, advisory boards, and CROs
• Represent Generate externally at scientific, medical, and regulatory meetings
• Hold teams to high standards for technical and collaborative performance
• Build and develop a diverse, high-performing, and inclusive team culture
• Promote enterprise thinking and cross-functional alignment with strategic goals
• Communicate with clarity, courage, and empathy across all levels of the organization
• Foster resilience, adaptability, and informed risk-taking in pursuit of innovation

Preferred Qualifications

• Previous work in both large pharma and biotech settings
• Knowledge of global regulatory requirements (e.g., FDA, EMA)
• Recent successful BLA submission preferred

Benefits

• Annual bonus
• Equity compensation
• Competitive benefits package