Clinical Trial Manager

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: 

• Support operational planning and execution of clinical trials from study start-up through close-out
• Manage CROs, central labs, and other clinical vendors to ensure delivery of key milestones
• Contribute to protocol development and review study-related documents including CRFs, ICFs, and study manuals
• Oversee site selection and initiation activities; maintain strong communication with investigators and site staff
• Participate in clinical study team meetings, support cross-functional coordination, and track study timelines
• Maintain Trial Master File (TMF) and ensure inspection readiness
• Track study metrics and assist in data cleaning and reconciliation activities
• Assist in review of monitoring reports and ensure follow-up on key findings
• Support budgeting, invoice reconciliation, and vendor contract management
• Coordinate investigator meetings and other study-related events

The Ideal Candidate will have:

• Bachelor’s degree in life sciences or related field; advanced degree a plus
• 3-5 years of experience in clinical trial operations, with at least 1 year independently managing aspects of a trial
• Working knowledge of GCP, ICH guidelines, and global regulatory requirements
• Demonstrated ability to manage vendors and collaborate across functions
• Strong written and verbal communication skills
• Proficiency in Microsoft Office and relevant clinical systems (e.g., EDC, eTMF)
• Organized, proactive, and detail-oriented, with a problem-solving mindset

Education

• Bachelor’s degree required; life sciences focus preferred

Nice to Have (Optional)

• Experience in respiratory, immunology, or oncology trials
• Prior exposure to IND-enabling studies or global trial execution
• Familiarity with AI-driven platforms or digital tools in clinical research

Why Join Us
At Generate, you’ll contribute to cutting-edge clinical programs powered by Generative Biology™. You’ll gain hands-on experience in a collaborative and dynamic team, while helping deliver novel therapeutics to patients faster.

Equal Opportunity Employer Statement
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 resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.

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Compensation: The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.