Senior Director, Clinical Data Management

🔥 23 hours ago

🇺🇸 United States – Remote

💵 $241k - $295k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Kailera Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2024

🔥 Funding within the last year

💰 $600M Series B - Kailera Therapeutics on 2025-10

Kailera Therapeutics (Kailera) is developing a broad, advanced, and differentiated portfolio of clinical-stage injectable and oral therapies for the treatment of obesity. Kailera’s most advanced program, KAI-9531 (being developed in China as HRS9531), is an injectable GLP-1/GIP receptor dual agonist that demonstrated positive clinical trial results in obesity in China. The Company is also advancing a diversified pipeline leveraging several mechanisms and routes of delivery. Kailera’s mission is to develop next-generation weight management therapies that give people the power to transform their lives and elevate their overall health. The Company is based in Waltham, MA and San Diego, CA. For more information, visit www.kailera.com.

📋 Description

• Define and execute the global clinical data management strategy • Scale the data infrastructure • Oversee end-to-end data integrity across all phases of clinical development • 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 • Ensure compliance with global regulatory standards and internal SOPs • Support regulatory audits and maintain inspection readiness • Cultivate cross-functional partnerships and represent Data Management in cross-functional forums and enterprise initiatives • Manage CRO relationships and ensure timely, high-quality deliverables • Establish quality metrics and governance frameworks

🎯 Requirements

• 10+ years of clinical data management experience within the pharmaceutical or biotechnology industry • 5+ years in a people-management role • Experience with large clinical trial data sets • Proven strategic data management leadership across late-stage development programs • Proven experience 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, ICH, GCP, and internal SOPs • Ability to build, mentor, and retain high-performing teams • Expertise in global CRO oversight, vendor management, and strategic outsourcing models • Advanced degree (Master) in Life Sciences, Statistics, Data Science, or a related quantitative field • E-Verify employment eligibility confirmation for new hires

🏖️ Benefits

• Comprehensive health coverage • Flexible time off • Paid holidays • Year-end shutdown • Monthly wellness stipend • Generous 401(k) match • Tuition reimbursement • Commuter benefits • Disability insurance • Life insurance • Annual bonus opportunities • Equity grants