Senior Director, Clinical Data Management

Kailera Therapeutics, Inc.

$241K — $295K *
US-AnywhereRemote in United States
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • 10+ years of clinical data management experience in pharma or biotech
  • 5+ years in a leadership role managing teams
  • Experience with large clinical trial data sets
  • Track record of strategic data management in late-stage programs
  • Expertise in regulatory compliance and inspection readiness
  • Proven ability to mentor and develop high-performing teams
  • Deep understanding of global CRO management and outsourcing

Responsibilities

  • Plan and manage clinical data quality and integrity full-lifecycle
  • Build and scale a high-performing Data Management team
  • Ensure compliance with global regulatory standards and internal SOPs
  • Foster cross-functional partnerships and represent Data Management
  • Manage CRO relationships for quality and timely deliverables

Benefits

  • Comprehensive health coverage
  • Flexible time off and 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
Full Job Description
What You'll Do:

We are seeking an experienced Data Management leader to join us as the Senior Director, Data Management. Reporting to VP, head of Biometrics, this role will define and execute the global clinical data management strategy, scale the data infrastructure, and oversee end-to-end data integrity across all phases of clinical development. As a strategic and operational leader, this individual will drive data quality, standardize processes, and ensure inspection readiness.

Responsibilities:
  • Actively plan and manage full-lifecycle clinical data quality and integrity across all trials (including eCRF builds, edit checks, external data integrations, reconciliations, data cleaning, database locks, and submission readiness).
  • Build and scale a high-performing Data Management organization; drive departmental performance, resource allocation, and talent development to maintain a resilient, growth-oriented team.
  • Drive strict compliance with global regulatory standards and internal SOPs while supporting regulatory audits and maintaining inspection readiness.
  • Cultivate strong cross-functional partnerships and represent Data Management in key cross-functional forums and enterprise initiatives.
  • Manage CRO relationships to ensure timely, high-quality deliverables, establishing robust quality metrics and governance frameworks.

Required Qualifications:
  • 10+ years of clinical data management experience within the pharmaceutical or biotechnology industry, including 5+ years in a people-management role.
  • Experience with large clinical trial data sets
  • Proven track record of providing strategic data management leadership across late-stage development programs, ensuring data integrity, data quality, and inspection readiness.
  • Proven track record of leading Data Management activities through successful global health authority filings (NDA, BLA, or MAA) and health authority interactions. .
  • Expert knowledge of clinical trial data management, CDASH standards, database lock execution, external data reconciliation (eCOA, central labs, PK, etc.), inspection readiness, and strict adherence to regulatory guidelines (e.g., ICH, GCP) and internal SOPs.
  • Proven ability to build, mentor, and retain high-performing teams while driving a culture of continuous improvement, accountability, and operational excellence.
  • Deep expertise in global CRO oversight, vendor management, and strategic outsourcing models to ensure high-quality deliverables, timeline adherence, and cost control.


Preferred Qualifications:
  • Experience in cardiometabolic disease areas preferred

Education:
  • Advanced degree (Master) in Life Sciences, Statistics, Data Science, or a related quantitative field.


Salary Range

$241,000-$295,000 USD

For Full Time Roles: This range represents the company's good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants-because your well-being and future matter to us.

#LI-Hybrid

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