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Senior Clinical Trial Manager at Generate:Biomedicines - ApplyBlast

Senior Clinical Trial Manager

Generate:Biomedicines

5 months ago

4.0 on Glassdoor

Hybrid

Full Time

Senior

2 applicants

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About this role

Generate Biomedicines seeks a Senior Clinical Trial Manager to lead the startup, execution, and closeout of late-stage clinical studies for its COPD program. Reporting to the Director of Clinical Operations, this role manages operational aspects including vendors, sites, and budgets while fostering collaboration across functional teams. The position involves overseeing compliance, mentoring junior staff, and ensuring the successful delivery of trial goals for asthma and COPD indications.

Responsibilities

Lead startup, execution, and closeout of late-stage clinical trials
Manage clinical study budgets, timelines, and third-party vendors
Oversee site selection, qualification, and investigator relationships
Ensure compliance with GCP and regulatory requirements globally
Mentor junior team members and develop standardized clinical processes

Skills

Qualifications

Bachelor's degree in Biomedical Science or related field8+ years of experience in clinical operations4+ years in late-stage trial operationsKnowledge of FDA, EMA, and MHRA regulations

About Generate:Biomedicines

generatebiomedicines.com

Headquarters

Somerville, Massachusetts, United States

Company Size

201-500 employees

View Profile

Generate:Biomedicines is a therapeutics company that combines machine learning, computational biology, and biological engineering to design and develop precision protein medicines and antibodies. Using generative AI and lab-driven engineering, the company builds targeted biologics and epitope-focused candidates, advancing a pipeline from discovery through clinical development. Its clinical-stage programs include GB-0895, a long‑acting anti‑TSLP antibody progressing to global Phase 3 studies, and the company has recently completed an initial public offering. Generate was incubated by Flagship Pioneering and emphasizes platform-driven discovery to accelerate novel biologic therapeutics.