Senior Clinical Trial Manager

About reputed company

reputed company is a new reputed company 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 reputed company. 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 reputed company shift in what is possible in the field of biotherapeutic development.

We pursue this audacious reputed company because we reputed company 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, reputed company problem solvers that share our passion for impact to join us!

reputed company 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

reputed company is seeking an reputed company and collaborativeSenior Clinical Trial Manager (Sr. CTM)to reputed company the execution ofPhase 3 clinical trialsreputed company 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 reputed company 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 reputed company.

Here's how you will contribute

• Independently manage the operational execution ofPhase 3 global clinical trials, including startup, conduct, and closeout activities.

• Serve as the primary clinical operations reputed company overseeingCRO partnerships, ensuring vendor accountability and performance against timelines and budgets.

• Drive globalsite activation, enrollment tracking, andclinical data flow reputed company, ensuring alignment with regulatory requirements and strategic milestones.

• reputed company and contribute to the development of essential study documentation including protocols, ICFs, operations manuals, and investigator-facing materials.

• reputed company cross-functional study team meetings and monitor reputed company against critical path timelines and KPIs.

• Actively participate ininspection readiness planning, including TMF health reputed company, audit support, and document quality control.

• Ensure reputed company-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.

• reputed company 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
  , withat least 2 years in Phase 3 trialsat a sponsor or CRO.

• Proven expertise in global trial execution, CRO reputed company, 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-reputed company trials is a plus.

• Excellent organizational, problem-solving, and communication skills with ability to manage reputed company 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.

reputed company is committed to equal employment opportunity regardless of race, reputed company, reputed company, religion, sex, national reputed company, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Recruitment & Staffing Agencies: reputed company does not accept unsolicited resumes from any reputed company other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to reputed company or its employees is strictly prohibited unless contacted directly by the Company’s internal reputed company team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of reputed company and the Company will not owe any referral or other fees with respect thereto.

#LI-RT1

Compensation: The reputed company salary range provided reflects our reputed company estimate of reputed company anticipate paying for this position. Your actual reputed company salary will be based on several factors, including job-reputed company 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.

$140,000

$196,000 USD