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

Generate Biomedicines•Somerville, MA

14d

About The Position

Generate:Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development. We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us! Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees. 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.

Requirements

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

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

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
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