Senior Director, Medical Monitor (Respiratory indications)

The Role:

Generate:Biomedicines is seeking an experienced physician for medical oversight of our 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.

Here’s how you will contribute:

· 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

Leadership Responsibilities:

· Hold teams to high standards for technical and collaborative performance

· Foster a high-performing, diverse, and inclusive team culture

· Promote enterprise thinking and strategic alignment across functions

· Communicate with clarity, courage, and empathy

· Model resilience, adaptability, and informed risk-taking

The Ideal Candidate will have:

· MD (required); board certification in Pulmonology or Allergy & Immunology preferred

· 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

Education MD required; additional scientific training (e.g., fellowship, MPH) a plus

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

Who Will Love This Job:

This is an exciting opportunity to shape the future of asthma care by advancing novel biologics using the power of generative biology. At Generate:Biomedicines, you’ll join a mission-driven team committed to scientific excellence!

About Generate:Biomedicines

We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation, this approach aims to reduce the uncertainty, time, and cost associated with developing protein-based medicines.

Founded in 2018, we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model, we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation.

At Generate:Biomedicines, we coll…