Associate Director, US Clinical Trial Liaison

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: 

We are seeking an experienced Associate Director, US Clinical Trial Liaison (CTL) to serve as a vital bridge between Generate:Biomedicines and U.S. clinical research sites. This individual contributor (with limited team leadership responsibilities) will work closely with investigators and site staff to ensure smooth, compliant, and high-performing execution of our clinical trials.

The CTL will drive site engagement, training, and enrollment strategy across assigned U.S. sites, while collaborating closely with Clinical Operations and CRO partners. This role includes mentoring junior CTLs and helping shape best practices within the U.S. region.

*This role will require up to <60% travel*

Here's how you will contribute:

• Serve as the primary sponsor contact for U.S. clinical trial sites, ensuring consistent communication and support throughout study execution.
• Train site personnel on protocols, study objectives, and the scientific rationale for investigational products.
• Collaborate with sites to develop and refine patient recruitment strategies to meet enrollment targets.
• Identify and resolve operational and compliance challenges in partnership with Clinical Operations and CROs.
• Conduct regular monitoring visits (remote and in-person) to build and sustain productive site relationships.
• Capture and relay insights from sites to inform operational decisions and protocol optimization.
• Contribute to feasibility assessments and site selection activities based on local treatment practices.
• Mentor junior CTLs on core responsibilities, compliance expectations, and communication best practices.
• Support the implementation of consistent standards across U.S. trial sites

The Ideal Candidate will have:

• Bachelor’s degree in a scientific or health-related field required.
• 8 years of clinical trial experience in the pharmaceutical or biotech industry, with deep knowledge of clinical operations and trial conduct.
• Proven ability to collaborate with investigators, site staff, and clinical operations teams to drive enrollment and ensure study integrity.
• Working knowledge of GCP, ICH guidelines, and U.S. regulatory requirements.
• Ability to travel up to 60% for site engagement, meetings, and events.
• Strong communication, problem-solving, and relationship-building skills.
• Comfortable using clinical trial systems (e.g., IRT, EDC, eTMF).

Nice to Have (Optional)

• Experience in respiratory, immunology, or oncology trials.
• 2+ years of prior CRA experience.
• Familiarity with AI-based tools or platforms in clinical development

Who Will Love This Job:

At Generate, you’ll be part of a team that’s reshaping the future of drug development through Generative Biology™. You’ll work with driven colleagues, help bring novel therapeutics to patients faster, and grow in a company that values curiosity, collaboration, and scientific excellence.

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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