Senior Director, Medical Monitor (Respiratory indications)

Generate Biomedicines

4d•$277,000 - $400,000

About The Position

Generate:Biomedicines is seeking an experienced physician for medical oversight of its late-stage Respiratory (asthma and COPD) programs. This individual will report to the Executive Director of Clinical Development and serve as the Senior Director Medical Monitor for Ph3 global trials, ensuring scientific rigor, patient safety, and executional excellence. The ideal candidate is an MD with deep respiratory expertise and a passion for transforming asthma and COPD care with innovative biologics.

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

Nice To Haves

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

Responsibilities

Provide day-to day medical oversight for late-stage clinical trials in asthma and/or COPD ensuring patient safety, protocol compliance, data integrity and inspection readiness
Serve as primary medical contact for clinical sites, investigators, and CROs
Perform subject eligibility review, ongoing data reviews, manage study queries, identify and assess protocol deviations
Serve as a member of the Clinical Development, Safety Management and Study Execution teams
Contributing author and key reviewer of core clinical and regulatory documents including IB, ICF, RFI, study protocols, DSUR
Support study oversight committees including DSMB, endpoint adjudication committee, etc.
Collaborate cross-functionally with Clinical Operations, Regulatory, Biostatistics, and Pharmacovigilance
Interpret clinical trial data and contribute to study reports, regulatory filings, and publications