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Active4w ago

Director, Clinical Data Management

Kailera Therapeutics, Inc.·📍 Waltham, Massachusetts, United States

Employment

Full-Time

Work mode

On-site

Experience

DIRECTOR

Salary

$196K – $240K/yr

Role overview

Job description

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team. What You’ll Do: Kailera Therapeutics is seeking an experienced Data Management professional to join as Director, Data Management. This role is accountable for the timely delivery and high-quality execution of Data Management deliverables across early- and late-phase clinical trials. The Directo

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What they are looking for

Skills & requirements

Qualification

10+ years of clinical data management experience in the pharmaceutical or biotechnology industry (8+ years with an advanced degree). Proven track record providing strategic data management leadership across late-stage development programs, ensuring data integrity, data quality, and inspection readiness. Expert knowledge of clinical trial data management, including CDASH standards, database lock execution, external data reconciliation (e.g., eCOA, central labs, PK), inspection readiness, and adherence to regulatory guidelines (e.g., ICH, GCP) and internal SOPs. Deep expertise in global CRO oversight, vendor management, and strategic outsourcing models to ensure high-quality deliverables, timeline adherence, and cost control. Demonstrated experience with eTMF systems and the documentation requirements related to Data Management. Strong command of electronic data capture (EDC) systems and clinical data warehousing technologies, with experience across a range of clinical data management platforms. Preferred

Department · Biometrics

KT

Hiring company

Kailera Therapeutics, Inc.

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