Senior Director, Clinical Data Management & Strategy

Kailera Therapeutics, Inc.; Waltham (MA); On-site; USD 241,000 - 295,000; Full time

Benefits offered by this job

Health coverage

Flexible time off

Paid holidays

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Disability insurance

Life insurance

Annual bonus

Equity grants

Job summary

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

Reporting to the VP of Biometrics, this role leads a high-performing team, ensures regulatory alignment (ICH/GCP) and audit readiness, and strengthens CRO partnerships to deliver timely, high-quality data for submission.

Qualifications

• 10+ years in clinical data management with 5+ in people management.
• Experience with large clinical trial data sets.
• Proven strategic data management leadership across late-stage development programs.
• Proven track record leading data management through NDA/BLA/MAA filings.
• Deep expertise in CDASH, database lock, external data reconciliation, inspection readiness, and regulatory guidelines.
• Ability to build and mentor high-performing teams.
• Global CRO oversight and vendor management experience.

Responsibilities

• Plan and manage full-lifecycle clinical data quality and integrity across all trials (eCRF, edit checks, reconciliations, data cleaning, submission readiness).
• Build and scale a high-performing Data Management organization; drive performance and growth.
• Drive compliance with regulatory standards and SOPs; support audits and 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 governance.

Skills

Data management leadership

People management

Clinical data management

Regulatory compliance

Vendor management

Cross-functional collaboration

Data quality

ICH/GCP knowledge

Education

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

Tools

eCRF systems

CDISC/CDASH

Job description

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

Reporting to the VP of Biometrics, this role leads a high-performing team, ensures regulatory alignment (ICH/GCP) and audit readiness, and strengthens CRO partnerships to deliver timely, high-quality data for submission.