Head of Global Clinical Data Management

Kailera Therapeutics

Waltham (MA)

Hybrid

USD 241,000 - 295,000

Full time

10 days ago
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Benefits offered by this job

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

Job summary

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

As a strategic and operational leader, you will drive data quality, standardize processes, ensure inspection readiness, and manage CRO relationships to deliver high-quality, timely results.

Qualifications

  • 10+ years in clinical data management within pharma/biotech.
  • 5+ years in a people-management role.
  • Experience with large clinical trial datasets and regulatory filings (NDA, BLA, MAA).
  • Deep knowledge of ICH, GCP and CDASH standards.
  • Proven ability to build and retain high-performing Data Management teams.

Responsibilities

  • Plan and manage full-lifecycle clinical data quality and integrity across trials (eCRF builds, edit checks, external data integrations, reconciliations, data cleaning, database locks, submission readiness).
  • Build and scale a high-performing Data Management organization; drive performance, resource allocation and talent development.
  • Drive regulatory compliance and inspection readiness; support audits and SOP adherence.
  • Represent Data Management in cross-functional forums and enterprise initiatives.
  • Manage CRO relationships to ensure high-quality deliverables, governance and timelines.

Skills

Clinical data management
People management
Data integrity
Regulatory compliance
CRO oversight

Education

Master's degree in Life Sciences, Statistics, Data Science, or related field

Job description

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

As a strategic and operational leader, you will drive data quality, standardize processes, ensure inspection readiness, and manage CRO relationships to deliver high-quality, timely results.

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