Director, Clinical Data Management — Hybrid, Global Lead

Kailera Therapeutics; Waltham (MA); Hybrid; USD 196,000 - 240,000; Full time

Benefits offered by this job

Health coverage

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Disability and life insurance

Annual bonus opportunities

Equity grants

Job summary

Kailera Therapeutics is seeking a Director of Data Management in Waltham, MA. You will drive data strategy across early- and late-stage trials and oversee vendor relationships to ensure data quality and regulatory readiness.

The role reports to the Head of Clinical Data Management and requires onsite collaboration 3–4 days per week. A strong background in CDASH, EDC, eTMF, and data warehousing is essential.

Qualifications

• 10+ years of clinical data management experience in pharma/biotech (8+ years with advanced degree).
• Strategic leadership across late-phase programs with data integrity and inspection readiness.
• Expert knowledge of regulatory guidelines (ICH/GCP) and SOPs.

Responsibilities

• Lead vendor oversight across global programs; align data management deliverables with CROs.
• Provide program-level leadership; monitor progress and report milestones.
• Represent Data Management on study teams; foster cross-functional collaboration.
• Monitor vendor performance; elevate issues and drive resolution strategies.
• Identify risks; develop mitigation or corrective action plans; ensure TMF readiness.
• Support study-level inspection readiness and audit preparation efforts.

Skills

CDASH standards

EDC systems

Vendors oversight

Data management leadership

GCP/ICH compliance

Global CRO oversight

eTMF systems

Data integrity

Education

Bachelor’s degree in Life Sciences

Tools

eTMF systems

EDC systems

Data warehousing technologies

Job description

Kailera Therapeutics is seeking a Director of Data Management in Waltham, MA. You will drive data strategy across early- and late-stage trials and oversee vendor relationships to ensure data quality and regulatory readiness.

The role reports to the Head of Clinical Data Management and requires onsite collaboration 3–4 days per week. A strong background in CDASH, EDC, eTMF, and data warehousing is essential.