Senior Director, Medical Monitor – Respiratory Indications

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee daily medical operations for late-stage asthma and/or COPD clinical trials, ensuring patient safety, adherence to protocols, data accuracy, and readiness for inspections.

• Act as the primary medical liaison for clinical sites, investigators, and CROs.

• Conduct subject eligibility assessments and continuous data evaluations.

• Oversee study inquiries and identify as well as evaluate protocol deviations.

• Participate in Clinical Development, Safety Management, and Study Execution teams.

• Assist in the creation and review of essential clinical and regulatory documents, such as the Investigator's Brochure (IB), Informed Consent Form (ICF), Requests for Information (RFI), study protocols, and Development Safety Update Reports (DSUR).

• Support study oversight committees, including the Data Safety Monitoring Board (DSMB) and endpoint adjudication committees.

• Work collaboratively with Clinical Operations, Regulatory Affairs, Biostatistics, and Pharmacovigilance teams.

• Analyze clinical trial data and contribute to study reports, regulatory submissions, and publications.

• Uphold high standards for technical excellence and teamwork performance.

• Cultivate a high-performing, diverse, and inclusive team environment.

• Encourage enterprise thinking and strategic alignment across various functions.

• Communicate with clarity, courage, and empathy.

• Exemplify resilience, adaptability, and informed risk-taking.

⛳️ Requirements

• MD (required).

• Minimum of 8 years of clinical development experience within the biopharma sector.

• In-depth knowledge of asthma and respiratory clinical trial design, management, and execution.

• Exceptional cross-functional leadership and communication abilities.

• Demonstrated capacity to collaborate effectively with both internal teams and external partners.

• Board certification in Pulmonology or Allergy & Immunology is preferred.

• Experience in both large pharmaceutical companies and biotech environments.

• Knowledge of global regulatory standards (e.g., FDA, EMA).

• Previous experience in successful Biologics License Application (BLA) or Marketing Authorization Application (MAA) submissions.

• Additional scientific qualifications (e.g., fellowship, Master of Public Health) are advantageous.

🏝️ Benefits

• Annual bonus.

• Equity compensation.

• Competitive benefits package.