Senior Director, Medical Monitor (Respiratory Indications)

TL;DR

Senior Director, Medical Monitor (Respiratory Indications): Medical oversight for late-stage asthma and COPD programs, ensuring patient safety, protocol compliance, data integrity, and inspection readiness with an accent on Ph3 global trial execution and primary medical contact responsibilities. Focus on interpreting clinical trial data, managing study queries and protocol deviations, and contributing to core clinical and regulatory documents.

Location: Remote

Salary: $277,000–$400,000 USD per year

Company

Clinical-stage generative biology company advancing AI-driven protein design and clinical development of protein-based medicines.

What you will do

• Provide day-to-day medical oversight for late-stage asthma and/or COPD clinical trials, ensuring patient safety, protocol compliance, data integrity, and inspection readiness
• Act as primary medical contact for clinical sites, investigators, and CROs; conduct subject eligibility review and ongoing data reviews
• Manage study queries and identify, assess, and address protocol deviations
• Contribute as a key reviewer and contributing author for core clinical and regulatory documents (IB, ICF, RFI, study protocols, DSUR)
• Support study oversight committees such as DSMB and endpoint adjudication committees
• Interpret trial data and contribute to study reports, regulatory filings, and publications while collaborating with Clinical Operations, Regulatory, Biostatistics, and Pharmacovigilance

Requirements

• MD required
• 8+ years of clinical development experience in the biopharma industry
• Extensive expertise in asthma and respiratory clinical trial design, oversight, and execution
• Strong cross-functional leadership and communication skills
• Proven ability to collaborate with internal teams and external stakeholders
• Board certification in Pulmonology or Allergy & Immunology preferred

Nice to have

• Experience in both large pharma and biotech settings
• Familiarity with global regulatory frameworks (e.g., FDA, EMA)
• Prior involvement in successful BLA or MAA submissions
• Additional scientific training (e.g., fellowship, MPH)

Culture & Benefits

• Annual bonus, equity compensation, and a competitive benefits package
• High standards for technical and collaborative performance
• High-performing, diverse, and inclusive team culture
• Clear communication expectations and emphasis on resilience and informed risk-taking