Senior Director, Clinical Development Medical Lead (Asthma and COPD)

. *** The addition of a cover letter with a  high-level  overview of your direct  expertise  in leading  late-stage  clinical trials in asthma and/or COPD would be  greatly appreciated  ***   The Role:  Generate:Biomedicines   is   seeking  a strategic and experienced Senior Director to lead clinical development and medical monitoring for our late-stage asthma  a nd COPD  program s .  This individual will report to the  Vice President   of Clinical Development and serve as the medical lead for global asthma 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 through innovative biologics.   Here's how you will contribute: Medical  Lead for the Clinical Development Team (CDT) to deliver Phase 3 asthma  and COPD  studies   Provide medical leadership and oversight for late-stage clinical trials in asthma  and COPD   Develop and refine clinical strategies and Target Product Profiles (TPPs) specific to asthma  and COPD   Serve as key author of late-stage clinical protocols, aligned with regulatory requirements   Author clinical and scientific content for regulatory submissions (e.g., BLA, MAA)   Oversee study design, protocol development, data review, and safety monitoring   Perform medical monitoring for late-stage studies, ensuring patient safety, protocol compliance, and data integrity   Serve as a member of the Safety Management Team (SMT)   Collaborate cross-functionally with Clinical Operations, Regulatory, Biostatistics, and Pharmacovigilance   Serve as primary medical contact for clinical sites, investigators, and CROs   Interpret clinical trial data and contribute to study reports, regulatory filings, and publications   Represent Generate at internal and external scientific and medical meetings   Engage with external experts, advisory boards, and health authorities to support program goals   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   Experience leading late-stage trials and engaging with regulatory bodies   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 (Optional)   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 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