Senior Director, Clinical Data Management

Kailera Therapeutics, Inc.; Waltham (MA); On-site; USD 241,000 - 295,000; Full time

Benefits offered by this job

Health coverage

Flexible time off

Paid holidays

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Disability insurance

Life insurance

Annual bonus

Equity grants

Job summary

Kailera Therapeutics, Inc. is seeking a Senior Director of Clinical Data Management to define and execute the global data strategy, scale infrastructure, and oversee data integrity across all phases of clinical development.

Reporting to the VP of Biometrics, this role leads a high-performing team, ensures regulatory alignment (ICH/GCP) and audit readiness, and strengthens CRO partnerships to deliver timely, high-quality data for submission.

Qualifications

• 10+ years in clinical data management with 5+ in people management.
• Experience with large clinical trial data sets.
• Proven strategic data management leadership across late-stage development programs.
• Proven track record leading data management through NDA/BLA/MAA filings.
• Deep expertise in CDASH, database lock, external data reconciliation, inspection readiness, and regulatory guidelines.
• Ability to build and mentor high-performing teams.
• Global CRO oversight and vendor management experience.

Responsibilities

• Plan and manage full-lifecycle clinical data quality and integrity across all trials (eCRF, edit checks, reconciliations, data cleaning, submission readiness).
• Build and scale a high-performing Data Management organization; drive performance and growth.
• Drive compliance with regulatory standards and SOPs; support audits and inspection readiness.
• Foster cross-functional partnerships and represent Data Management in key forums and initiatives.
• Manage CRO relationships to ensure timely, high-quality deliverables and governance.

Skills

Data management leadership

People management

Clinical data management

Regulatory compliance

Vendor management

Cross-functional collaboration

Data quality

ICH/GCP knowledge

Education

Master's degree in Life Sciences/Statistics/Data Science

Tools

eCRF systems

CDISC/CDASH

Job description

Senior Director, Clinical Data Management

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:

We are seeking an experienced Data Management leader to join us as the Senior Director, Data Management. Reporting to VP, head of Biometrics, this role will define and execute the global clinical data management strategy, scale the data infrastructure, and oversee end-to-end data integrity across all phases of clinical development. As a strategic and operational leader, this individual will drive data quality, standardize processes, and ensure inspection readiness.

Responsibilities:

• Actively 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 to maintain a resilient, growth-oriented team.
• Drive strict compliance with global regulatory standards and internal SOPs while supporting regulatory audits and maintaining inspection readiness.
• Cultivate strong cross-functional partnerships and represent Data Management in key cross-functional forums and enterprise initiatives.
• Manage CRO relationships to ensure timely, high-quality deliverables, establishing robust quality metrics and governance frameworks.

Required Qualifications:

• 10+ years of clinical data management experience within the pharmaceutical or biotechnology industry, including 5+ years in a people-management role.
• Experience with large clinical trial data sets
• Proven track record of providing strategic data management leadership across late-stage development programs, ensuring data integrity, data quality, and inspection readiness.
• Proven track record of 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, and strict adherence to regulatory guidelines (e.g., ICH, GCP) and internal SOPs.
• Proven ability to build, mentor, and retain high-performing teams while driving a culture of continuous improvement, accountability, and operational excellence.
• Deep expertise in global CRO oversight, vendor management, and strategic outsourcing models to ensure high-quality deliverables, timeline adherence, and cost control.

Preferred Qualifications:

• Experience in cardiometabolic disease areas preferred

Education:

• Advanced degree (Master) in Life Sciences, Statistics, Data Science, or a related quantitative field.

Salary Range

$241,000 - $295,000 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.

This role requires you to be on-site in Waltham, Massachusetts 3-4 days per week.