Senior Director, Clinical Development (COPD)

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 Role: 

Generate:Biomedicines is seeking a strategic and experienced Senior Director to lead clinical development and medical monitoring for our late-stage COPD program. Reporting to the VP, Respiratory Products Leader, this role will serve as the medical lead for global COPD trials. The successful candidate will ensure data integrity, safety oversight, and scientific excellence while shaping the strategy to advance novel biologics in COPD care.

Here's how you will contribute:

• Lead the Clinical Development Team (CDT) to deliver Phase 3 COPD studies
• Provide medical leadership and oversight for late-stage clinical trials in 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)
•  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)
• Guide the development and optimization of COPD-specific clinical strategies and Target Product Profiles (TPPs)
• Lead protocol development, study design, and clinical data review
• Ensure safety monitoring and collaboration with cross-functional partners (PV, Regulatory, Clinical Operations, Biostats,)
• Act as the primary medical contact for sites, investigators, and CROs
• Analyze clinical data and contribute to clinical study reports, publications, and regulatory submissions
• Represent Generate at scientific and regulatory meetings
• Interface with key opinion leaders, advisory boards, and regulatory agencies to support program advancement

Leadership Responsibilities:

• Set high expectations for technical excellence and collaborative success
• Build and sustain a diverse, high-performing team environment
• Align functional strategies with broader company objectives
• Communicate transparently, effectively, and with empathy
• Demonstrate adaptability and promote smart risk-taking

The Ideal Candidate will have:

• MD (required); board certification in Pulmonology or Allergy & Immunology preferred
• 8+ years of clinical development experience in biopharma
• Significant expertise in COPD clinical trial design and respiratory therapeutics
• Experience with global late-stage studies and regulatory engagement
• Strong leadership, analytical, and interpersonal communication skills
• Proven ability to manage cross-functional teams and external partnerships

Education: MD required; advanced clinical or scientific training (e.g., fellowship, MPH) is a plus

Nice to Have (Optional)

• Experience in both biotech and large pharma environments
• Familiarity with global regulatory processes (FDA, EMA)
• Experience with successful late-stage submissions (e.g., BLA, MAA)

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

Who Will Love This Job:

This is a rare opportunity to lead the development of innovative COPD therapies at a company pushing the boundaries of what’s possible through generative biology. You'll be part of a collaborative, passionate team focused on science, patients, and impact.

 

Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, rel