Kailera Therapeutics, Inc. Logo

Kailera Therapeutics, Inc.

Senior Director, Clinical Data Management

Posted 21 Days Ago
Be an Early Applicant
Remote or Hybrid
Hiring Remotely in US
241K-295K Annually
Senior level
Remote or Hybrid
Hiring Remotely in US
241K-295K Annually
Senior level
Lead global clinical data management strategy across all clinical development phases. Oversee data quality, eCRF builds, edit checks, integrations, reconciliations, data cleaning, database locks, submission readiness, regulatory compliance, CRO oversight, and inspection readiness. Build and develop a high-performing data management organization, establish governance and quality metrics, manage resources, and represent Data Management in cross-functional initiatives.
The summary above was generated by AI

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.

 #LI-Hybrid

Similar Jobs

One Month Ago
Remote
USA
230K-280K Annually
Senior level
230K-280K Annually
Senior level
Healthtech • Biotech
Lead global clinical data management strategy and operations across Phase I-IV trials. Oversee CRF design, database builds, edit checks, data quality, governance, vendor/CRO relationships, regulatory inspection readiness, modernization (automation/AI), budgeting, and talent development to deliver regulatory-compliant clinical datasets.
Top Skills: Ai-Enabled Data ReviewCdisc StandardsCdms PlatformsClinical Data PlatformsCrf DesignDatabase BuildEdc SystemsEdit ChecksSdtm
54 Minutes Ago
Remote
USA
Junior
Junior
Insurance • Financial Services
Supports sales teams and broker partners through prospecting, quoting, proposals, enrollments, renewals, RFPs, licensing, and producer appointments. Maintains pipeline and process tracking, coordinates with internal teams and third-party administrators, responds to product inquiries, supports broker training, and manages Salesforce records. The remote role may require occasional travel of less than 10% for open enrollment meetings.
Top Skills: ExcelMicrosoft Office SuiteOutlookPowerPointSalesforceTableauWord
An Hour Ago
Remote or Hybrid
United States
88K-110K Annually
Mid level
88K-110K Annually
Mid level
Digital Media • Gaming • Information Technology • Software • Sports • Esports • Big Data Analytics
Develops revenue opportunities for the Lottery business by building financial cases, defining success metrics, coordinating cross-functional plans, and evaluating performance. Serves as a key partner contact, aligns stakeholders, manages launch-readiness dependencies, and communicates data-driven recommendations. Requires strong quantitative modeling, testing, data integrity, and business planning skills.
Top Skills: Ai-Assisted AnalysisBusiness Intelligence ToolsPresentation SoftwareSpreadsheet Software

What you need to know about the Charlotte Tech Scene

Ranked among the hottest tech cities in 2024 by CompTIA, Charlotte is quickly cementing its place as a major U.S. tech hub. Home to more than 90,000 tech workers, the city’s ecosystem is primed for continued growth, fueled by billions in annual funding from heavyweights like Microsoft and RevTech Labs, which has created thousands of fintech jobs and made the city a go-to for tech pros looking for their next big opportunity.

Key Facts About Charlotte Tech

  • Number of Tech Workers: 90,859; 6.5% of overall workforce (2024 CompTIA survey)
  • Major Tech Employers: Lowe’s, Bank of America, TIAA, Microsoft, Honeywell
  • Key Industries: Fintech, artificial intelligence, cybersecurity, cloud computing, e-commerce
  • Funding Landscape: $3.1 billion in venture capital funding in 2024 (CED)
  • Notable Investors: Microsoft, Google, Falfurrias Management Partners, RevTech Labs Foundation
  • Research Centers and Universities: University of North Carolina at Charlotte, Northeastern University, North Carolina Research Campus

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account