Job description
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 millionin 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 an experienced and collaborative Senior Clinical Trial Manager (Sr. CTM) to lead the execution of Phase 3 clinical trials within our Clinical Development team. This role will report to the Sr. Director of Late Stage Clinical Operations and be responsible for managing global, late-stage studies intended to support regulatory submissions and eventual product approval.
The Sr. CTM will work cross-functionally across Clinical Development, Regulatory Affairs, Clinical Supply, and Data Management, while serving as a key point of contact for CROs, vendors, and clinical sites. This is a critical role for ensuring operational excellence, compliance, and delivery in high-stakes studies where quality and precision are paramount.
Here’s how you will contribute:
- Independently manage the operational execution of Phase 3 global clinical trials, including startup, conduct, and closeout activities.
- Serve as the primary clinical operations lead overseeing CRO partnerships, ensuring vendor accountability and performance against timelines and budgets.
- Drive global site activation, enrollment tracking, and clinical data flow oversight, ensuring alignment with regulatory requirements and strategic milestones.
- Oversee and contribute to the development of essential study documentation including protocols, ICFs, operations manuals, and investigator-facing materials.
- Lead cross-functional study team meetings and monitor progress against critical path timelines and KPIs.
- Actively participate in inspection readiness planning, including TMF health oversight, audit support, and document quality control.
- Ensure real-time issue escalation, risk mitigation, and resolution of site, CRO, or operational challenges.
- Collaborate with regulatory and quality teams to ensure trial execution aligns with global GCP, FDA, EMA, and ICH standards.
- Lead vendor and budget management for assigned studies, including contract execution and ongoing financial tracking.
- Mentor junior clinical team members and contribute to SOP development and process optimization for late-stage trial conduct.
The Ideal Candidate will have:
- Bachelor’s degree required; advanced scientific degree preferred.
- 4+ years of clinical trial management experience, with at least 2 years in Phase 3 trials at a sponsor or CRO.
- Proven expertise in global trial execution, CRO oversight, and clinical vendor management is required.
- Experience in various therapeutic areas (including oncology, immunology, and respiratory, if possible)
- Strong knowledge of GCP, ICH guidelines, and FDA/EMA regulatory expectations for pivotal studies.
- Experience supporting regulatory submission activities or NDA/BLA-aligned trials is a plus.
- Excellent organizational, problem-solving, and communication skills with ability to manage complex workflows and stakeholder expectations.
- Comfortable with limited travel (up to 30%) to support global study needs, site visits, or vendor engagement.
- Ability to travel up to 30% of the time, both domestic and international.
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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