Director, Clinical Data Management

The role

The Director, Data Management is accountable for the timely delivery and high-quality execution of Data Management deliverables across early- and late-phase clinical trials. This person will partner with key study stakeholders to define and implement a clear, comprehensive data strategy for assigned programs and studies.

What you will do

• Lead vendor oversight activities across global development programs
• Provide program-level leadership and oversight of clinical data management activities
• Monitor and report on program and study progress
• Represent the Data Management function on the study team
• Monitor vendor performance and quality metrics
• Escalate issues to management and drive resolution strategies
• Identify risks and implement mitigation or corrective action plans
• Ensure Data Management Trial Master File (TMF) documentation is filed accurately
• Support study-level inspection readiness and audit preparation efforts

Required qualifications

• 10+ years of clinical data management experience in the pharmaceutical or biotechnology industry (8+ years with an advanced degree)
• Proven track record providing strategic data management leadership across late-stage development programs
• Expert knowledge of clinical trial data management, including CDASH standards, database lock execution, external data reconciliation, inspection readiness, and adherence to regulatory guidelines (e.g.
• Deep expertise in global CRO oversight, vendor management, and strategic outsourcing models
• Demonstrated experience with eTMF systems and the documentation requirements related to Data Management
• Strong command of electronic data capture (EDC) systems and clinical data warehousing technologies
• Bachelor’s degree in Life Sciences, or a related field

Nice to have

• Experience in cardiometabolic disease areas
• Experience with large clinical trial data sets
• Track record leading Data Management activities through successful global health authority filings (NDA, BLA, or MAA) and health authority interactions

Benefits

• Comprehensive health coverage
• Flexible time off
• Paid holidays
• Year-end shutdown
• Monthly wellness stipend
• Generous 401(k) match
• Tuition reimbursement
• Commuter benefits
• Disability and life insurance
• Annual bonus opportunities
• Equity grants

Before you apply

• Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires

About the company

Kailera is working to advance novel therapies for obesity and related conditions. The company is rooted in an entrepreneurial spirit and a team-oriented culture.