Senior Director, Clinical Data Management – Onsite Leader

Kailera Therapeutics; Boston (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

Annual bonus opportunities

Job summary

Kailera Therapeutics is seeking an experienced Director, Data Management to ensure timely delivery and high-quality data management deliverables across early- and late-phase clinical trials. This role partners with study stakeholders to define a comprehensive data strategy and reports to the Head of Clinical Data Management.

Location is Waltham, MA with on-site presence 3-4 days per week. The candidate brings 10+ years in clinical data management, expertise in CDASH, eTMF, EDC, and global CRO

Qualifications

• 10+ years of clinical data management experience in pharma/biotech, with 8+ years if advanced degree.
• Proven track record leading data management across late-stage programs, ensuring data integrity and inspection readiness.
• Deep knowledge of CDASH, database lock, external data reconciliation (eCOA, PK), and regulatory guidelines (ICH, GCP).
• Experience with global CRO oversight, vendor management, and outsourcing models to ensure quality, timelines, and cost control.

Responsibilities

• Lead vendor oversight across global development programs and align with CROs on DM deliverables.
• Provide program-level leadership and monitor progress of data management activities.
• Represent the DM function on study teams and foster cross-functional collaboration.
• Monitor vendor performance, escalate issues, and drive resolution strategies.
• Identify risks and implement mitigation or corrective action plans to maintain data quality.

Skills

Data management leadership

Vendor oversight

CDASH standards

EDC systems

Inspection readiness

Global CRO oversight

eTMF systems

Data reconciliation

Clinical data warehousing

Regulatory knowledge (ICH/GCP)

Education

Bachelor’s degree in Life Sciences

Tools

eTMF systems

EDC systems

CDASH standards

Clinical data warehousing

Job description

Kailera Therapeutics is seeking an experienced Director, Data Management to ensure timely delivery and high-quality data management deliverables across early- and late-phase clinical trials. This role partners with study stakeholders to define a comprehensive data strategy and reports to the Head of Clinical Data Management.

Location is Waltham, MA with on-site presence 3-4 days per week. The candidate brings 10+ years in clinical data management, expertise in CDASH, eTMF, EDC, and global CRO