Senior Clinical Trial Manager (Fully Remote)

Kailera Therapeutics; United States; Remote; USD 140,000 - 230,000; Full time

Benefits offered by this job

Health coverage

Flexible time off

Paid holidays

Year-end shutdown

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Annual bonus opportunities

Equity grants

Job summary

Kailera Therapeutics is seeking an experienced clinical operations leader to manage planning, execution, and oversight of complex multinational clinical trials across all development phases. This role acts as operational lead to ensure milestones are met on time, within budget, and in compliance with GCP/ICH regulatory standards.

You will collaborate cross-functionally, manage external CROs and vendors with minimal oversight, and drive solutions to challenges.

Qualifications

• 8+ years of clinical trial experience with direct management of CROs and vendors.
• Deep understanding of GCP, ICH guidelines, and regulatory frameworks relevant to global clinical trial management.
• Strong problem-solving, organizational, and analytical skills with the ability to anticipate challenges and implement solutions.

Responsibilities

• Manage planning, execution, and oversight of clinical trials across all phases of development.
• Act as operational lead ensuring milestones are met on time, within budget, and in compliance with regulatory and quality standards.
• Collaborate cross-functionally and manage external partners with minimal oversight.

Skills

Clinical trial management

CRO/vendor management

Regulatory knowledge (GCP/ICH)

Analytical thinking

Cross-functional collaboration

Job description

• Manage planning, execution, and oversight of clinical trials across all phases of development.
• Act as operational lead ensuring milestones are met on time, within budget, and in compliance with regulatory and quality standards.
• Collaborate cross-functionally and manage external partners with minimal oversight.

Required Qualifications:

• 8+ years of clinical trial experience with direct management of CROs and vendors.
• Deep understanding of GCP, ICH guidelines, and regulatory frameworks relevant to global clinical trial management.
• Strong problem-solving, organizational, and analytical skills with the ability to anticipate challenges and implement solutions.

What We Offer:

• Comprehensive health coverage, flexible time off, paid holidays, and year-end shutdown.
• Monthly wellness stipend, generous 401(k) match, tuition reimbursement, and commuter benefits.
• Annual bonus opportunities and equity grants.

Kailera Therapeutics

Kailera Therapeutics is a biotech company focused on developing novel therapies for obesity and related conditions. The company fosters an entrepreneurial, team-oriented culture that values collaboration, integrity, and excellence.