Director, Clinical Data Management

OpenKrill; United States; Híbrido; USD 196.000 - 240.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health coverage

401(k) match

Tuition reimbursement

Commuter benefits

Disability and life insurance

Annual bonus opportunities

Equity grants

Descripción de la vacante

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

Location options include on-site in Waltham, MA or remote with periodic hub-based onsite visits. The role requires deep expertise in CDASH, eTMF, EDC, and global CRO oversight to ensure data integrity

Formación

• 10+ years in clinical data management in pharma/biotech (8+ with advanced degree)
• Proven leadership across late-stage programs with data integrity and inspection readiness
• Expert knowledge of CDASH, DB lock, external data reconciliation, and regulatory guidelines

Responsabilidades

• Lead vendor oversight across global programs ensuring alignment with CROs
• Provide program-level leadership for CV management activities and monitor progress
• Represent Data Management on study teams and ensure cross-functional alignment
• Monitor vendor performance and drive correction actions
• Identify risks and implement mitigation or corrective action plans
• Maintain TMF documentation in inspection-ready state
• Support inspection readiness and audit prep efforts

Conocimientos

Clinical data management

Strategic leadership

Vendor management

GCP/ICH compliance

CDASH standards

eTMF oversight

EDC proficiency

Cross-functional collaboration

Educación

Bachelor's degree in Life Sciences

Herramientas

EDC systems

eTMF systems

Data warehousing

Descripción del empleo

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 Director partners closely with key study stakeholders to define and implement a clear, comprehensive data strategy for assigned programs and studies. This position reports directly to the Head of Clinical Data Management.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week) OR Remote (home-based, onsite at a hub 1 week every other month).

Responsibilities:

• Lead vendor oversight activities across global development programs, ensuring alignment between Kailera and CROs on all data management deliverables.
• Provide program-level leadership and oversight of clinical data management activities; monitor and report on program and study progress.
• Represent the Data Management function on the study team, fostering cross-functional collaboration and clear expectations.
• Monitor vendor performance and quality metrics, escalated issues to management, and drive resolution strategies.
• Proactively identify risks and develop and implement mitigation or corrective action plans.
• Ensure Data Management Trial Master File (TMF) documentation is filed accurately and maintained in an inspection-ready state.
• Support study-level inspection readiness and audit preparation efforts.

Required Qualifications:

• 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 Qualifications:

• Experience in cardiometabolic disease areas.
• Experience with large clinical trial data sets.
• Track record leading Data Management activities through successful global health authority filings (NDA, BLA, or MAA) and health authority interactions.

Education:

• Bachelor’s degree in Life Sciences, or a related field.

Salary Range$196,000-$240,000 USD

For Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

E-Verify:

Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.

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