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 readinessServe as primary medical contact for clinical sites, investigators, and CROs Perform subject eligibility review, ongoing data reviews, manage study queries, identify and assess protocol deviationsServe as a member of the Clinical Development, Safety Management and Study Execution teamsContributing author and key reviewer of core clinical and regulatory documents including IB, ICF, RFI, study protocols, DSURSupport study oversight committees including DSMB, endpoint adjudication committee, etc.Collaborate cross-functionally with Clinical Operations, Regulatory, Biostatistics, and PharmacovigilanceInterpret clinical trial data and contribute to study reports, regulatory filings, and publications Leadership Responsibilities Hold teams to high standards for technical and collaborative performanceFoster a high-performing, diverse, and inclusive team culturePromote enterprise thinking and strategic alignment across functionsCommunicate with clarity, courage, and empathyModel resilience, adaptability, and informed risk-taking The Ideal Candidate Will Have MD (required); board certification in Pulmonology or Allergy & Immunology preferred8+ years of clinical development experience in the biopharma industryExtensive expertise in asthma and respiratory clinical trial design, oversight, and executionStrong cross-functional leadership and communication skillsProven 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 settingsFamiliarity 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 collaborate across disciplines in new ways to invent and innovate. We bring diverse perspectives to a shared goal of delivering better medicines to patients in need, faster, guided by our values and leadership behaviors. Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. Recruitment & Staffing Agencies*: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.*