Senior Clinical Trial Lead — Hybrid (Onsite/Remote)

Kailera Therapeutics, Inc.; United States; Hybrid; USD 143,000 - 175,000; Full time

Benefits offered by this job

Health coverage

Flexible time off

Paid holidays

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Equity grants

Job summary

Kailera Therapeutics, Inc. in Waltham, MA (onsite 3-4 days/week) or remote with periodic hub visits is seeking a Senior Clinical Trial Manager to lead planning, execution and oversight of trials across development phases.

You will manage CROs, vendors, study plans, data review, and TMF while mentoring team members and driving process improvements in GCP/ICH compliance. Travel required.

Qualifications

• Bachelor's degree in life sciences or a related field.
• 8+ years of clinical trial experience with CRO/vendor management.
• Strong knowledge of GCP, ICH guidelines, and global regulatory frameworks.
• Excellent written and verbal communication skills and stakeholder management.
• Willingness to travel as needed.

Responsibilities

• Serve as the primary operational lead for assigned clinical trials, accountable for end-to-end trial execution, including oversight of CROs and vendors from study start-up through close-out.
• Lead cross-functional trial teams to ensure alignment on timelines, deliverables, risk mitigation, and study objectives.
• Independently manage key trial activities, such as protocol development, site selection, study conduct, monitoring, data review, and database lock.
• Oversee and review key clinical trial documents ensuring quality and regulatory compliance.
• Monitor CRO performance and resolve issues to meet timelines and budgets.
• Lead development and review of study plans and vendor SOPs with proper documentation and risk mitigation.
• Ensure timely data query resolution and corrective actions; maintain Trial Master Files and inspection readiness.
• Mentor or manage junior team members and contribute to process improvements and knowledge sharing.
• Collaborate with QA, Regulatory, and cross-functional stakeholders to ensure compliance with GCP, ICH, and global regulatory guidelines.

Skills

Clinical trial management

Cross-functional leadership

GCP/ICH knowledge

Vendor negotiations

Communication

Education

Bachelor’s degree in life sciences

Tools

MS Project

Smartsheet

Job description

Kailera Therapeutics, Inc. in Waltham, MA (onsite 3-4 days/week) or remote with periodic hub visits is seeking a Senior Clinical Trial Manager to lead planning, execution and oversight of trials across development phases.

You will manage CROs, vendors, study plans, data review, and TMF while mentoring team members and driving process improvements in GCP/ICH compliance. Travel required.