Director, Clinical Data Management – Onsite Global Data Strategy

Kailera Therapeutics, Inc.; Waltham (MA); On-site; USD 196,000 - 240,000; Full time

Benefits offered by this job

Health coverage

401(k) match

Tuition reimbursement

Commuter benefits

Equity grants

Wellness stipend

Annual bonus opportunities

Paid holidays

Flexible time off

Year-end shutdown

Job summary

Kailera Therapeutics, Inc. is seeking an experienced Director, Data Management to lead data management deliverables across early- and late-stage clinical trials in a hub-based, onsite role in Waltham, MA.

Reporting to the Head of Clinical Data Management, you will oversee vendor management across global programs, drive data strategy, ensure inspection readiness, and collaborate with cross-functional teams to uphold data integrity and regulatory compliance.

Qualifications

• 10+ years of clinical data management experience in pharma/biotech.
• Strategic leadership across late-stage programs for data integrity and inspection readiness.
• Expert knowledge of CDASH, database lock, external data reconciliation (eCOA, PK).
• CRO oversight, vendor management, and outsourcing models.
• Experience with eTMF systems and related documentation requirements.
• Strong command of EDC systems and data warehousing technologies.

Responsibilities

• Lead vendor oversight activities across global development programs and CROs.
• Provide program-level leadership and monitor study progress.
• Represent Data Management on study teams and drive cross-functional collaboration.
• Monitor vendor performance, escalate issues, and drive resolution strategies.
• Identify risks and implement mitigation or corrective actions.
• Ensure TMF documentation is accurate and inspection-ready.
• Support study-level inspection readiness and audit preparation.

Skills

Data management leadership

CDASH standards

Vendor management

eTMF systems

EDC systems

Regulatory compliance (ICH/GCP)

Education

Bachelor’s degree in Life Sciences

Job description

Kailera Therapeutics, Inc. is seeking an experienced Director, Data Management to lead data management deliverables across early- and late-stage clinical trials in a hub-based, onsite role in Waltham, MA.

Reporting to the Head of Clinical Data Management, you will oversee vendor management across global programs, drive data strategy, ensure inspection readiness, and collaborate with cross-functional teams to uphold data integrity and regulatory compliance.