Senior Director, Clinical Development (Asthma)

About Generate:Biomedicines

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.

*** 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 program. This individual will report to the VP, Global Respiratory Product Leader 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 care through innovative biologics.

Here's how you will contribute:

• Lead the Clinical Development Team (CDT) to deliver Phase 3 asthma studies
• Provide medical leadership and oversight for late-stage clinical trials in asthma
• Develop and refine clinical strategies and Target Product Profiles (TPPs) specific to asthma
• 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)
• Manage oversight committees for late-stage asthma studies (e.g., DSMB, Endpoint Adjudication Committee)
• 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 small biotech settings
• Familiarity with global regulatory requirements (e.g., FDA, EMA)
• Prior involvement in successful BLA or MAA submissions

Location: Somerville, MA / Andover, MA; remote (U.S.) optional with travel to HQ based on business needs.

Why Join Us?

This is an exciting opportunity to