Global Head, Clinical Data Management

Kailera Therapeutics

United States

On-site

USD 241,000 - 295,000

Full time

2 days ago
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Benefits offered by this job

Health coverage
Flexible time off
Paid holidays
Wellness stipend
401(k) match
Tuition reimbursement
Commuter benefits
Life insurance
Disability insurance
Annual bonus opportunities
Equity grants

Job summary

Kailera Therapeutics in the United States is seeking a Senior Director, Data Management to define and execute the global data management strategy, scale data infrastructure, and oversee end-to-end data integrity across clinical development.

Reporting to the VP, head of Biometrics, you will build a high-performing Data Management organization, ensure inspection readiness, manage CRO relationships, and drive data quality, standardization and regulatory compliance across trials.

Qualifications

  • 10+ years in clinical data management in pharma/biotech.
  • 5+ years in people management.
  • Experience with large clinical trial datasets and health authority filings.
  • Deep expertise in CDASH, data integrity, data quality, and inspection readiness.

Responsibilities

  • Plan and manage full-lifecycle data quality and integrity across trials (eCRF builds, edit checks, data reconciliation, database locks, submission readiness).
  • Build and scale Data Management organization; drive performance, resource allocation, and talent development.
  • Drive regulatory compliance, support audits, and maintain inspection readiness.
  • Foster cross-functional partnerships and represent Data Management in key forums and initiatives.
  • Manage CRO relationships to ensure timely, high-quality deliverables and cost control.

Skills

Data management leadership
People management
Regulatory compliance
Vendor/CRO oversight
Cross-functional collaboration

Education

Master's degree in Life Sciences / Statistics / Data Science

Tools

CDASH
eCOA
Database locks
Regulatory submissions (NDA/BLA/MAA)

Job description

Kailera Therapeutics in the United States is seeking a Senior Director, Data Management to define and execute the global data management strategy, scale data infrastructure, and oversee end-to-end data integrity across clinical development.

Reporting to the VP, head of Biometrics, you will build a high-performing Data Management organization, ensure inspection readiness, manage CRO relationships, and drive data quality, standardization and regulatory compliance across trials.

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