Senior Director, Clinical Data Management
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Senior Director leading clinical data management for Kailera’s obesity and related-condition therapies. Driving global data integrity, regulatory readiness, CRO oversight, and team growth.
Responsibilities:
- 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
Similar Jobs
Associate Director, Clinical Supply Chain
Associate Director managing clinical drug supply strategies, packaging, labeling, and shipments for Elevar Therapeutics’ global biotech trials. Ensuring timely, compliant supply across clinical sites.
Medical Director – Utilization Management
Medical Director optimizing utilization management and clinical quality for Alignment Health’s senior-focused healthcare services. Conducting remote medical-necessity reviews and overseeing UM clinical staff.
Director, Clinical Programs – IKC
DaVita value-based care director designing and scaling integrated clinical programs for kidney disease patients. Leading pilots, analytics, financial models, and cross-functional care innovation.
Medical Director, Autoimmune Disease
Medical Director leading autoimmune diagnostics clinical strategy at Adaptive Biotechnologies. Advancing evidence generation, product development, and commercialization with medical and cross-functional teams.
Oncology Field Medical Director, Thoracic
Pfizer field medical director advancing thoracic oncology care across New York. Delivering scientific education, clinical-trial support, and actionable insights to healthcare professionals.
Oncology Field Medical Director, Thoracic
Pfizer oncology medical director guiding thoracic cancer education and medical strategy across New England. Supporting clinical trial sites, healthcare professionals, patient advocacy, and evidence generation.
Director, Medical Payer Strategy – Eye Care, Neurotoxins
AbbVie director shaping payer access, HCDM, and RWE strategy for eye care and neurotoxin medicines. Guiding cross-functional medical, HEOR, commercial, and regulatory initiatives.
Senior Director, Clinical Outreach
Senior Director leading clinical outreach teams and healthcare partnerships for Newport Healthcare’s behavioral health treatment centers. Driving referrals, business development, compliance, and regional performance.
Medical Director
Medical Director overseeing AI-driven chronic condition management and hospital-at-home care. Guiding clinical quality, protocols, virtual care operations, and technology-enabled patient outcomes.
Fractional Chief Medical Officer
Fractional Chief Medical Officer advancing CopilotIQ+Biofourmis’ AI-driven in-home care platform. Leading clinical strategy, enterprise sales support, partnerships, and outcomes research.
Executive Medical Director, DME/IRF
Medical Director overseeing EviCore’s DME and IRF utilization management programs. Leading clinical guidelines, physician supervision, audits, appeals, and medical necessity reviews.
Medical Director – Physical Medicine & Rehabilitation
Medical Director conducting evidence-based medical necessity reviews for EviCore, part of Evernorth’s healthcare solutions business. Performing peer-to-peer consultations and recommending appropriate treatments remotely.
Medical Director – Radiation Oncology
Medical Director conducting evidence-based radiation oncology reviews for Evernorth healthcare solutions. Consulting referring physicians and recommending medically appropriate treatments remotely.
Senior Director, Medical Writing
Senior Director leading regulatory and clinical medical writing for Liquidia, a company developing pulmonary arterial hypertension therapies. Guiding global submissions, health authority interactions, and cross-functional document strategy.
Director, Medical Writing
Medical Writing Director developing clinical and regulatory documents for Summit Therapeutics’ oncology programs. Leading document reviews, timelines, and cross-functional regulatory submissions.
Senior Industry Practice Director – Healthcare Provider
Healthcare Provider industry director shaping UiPath’s automation strategy for health systems and hospitals. Building market POVs, repeatable sales plays, and executive customer engagement.
Medical Director – Senior Medical Director, Cardiology
Medical Director overseeing cardiology clinical trials and pharmacovigilance at Thermo Fisher Scientific. Reviewing safety data, regulatory reports, and medical decisions across global studies.
Lead Director, Medical Policy Optimization and Customization
CVS Health enterprise policy compliance leader optimizing medical policy governance and regulatory adherence. Driving quality, risk reduction, executive reporting, and cross-functional change.
Director, Clinical Insights
Clinical Insights Director managing oncology-focused provider programs, advisory boards, and pharmaceutical client deliverables. Leading clinical strategy, reporting, presentations, and stakeholder relationships for Cencora’s pharmaceutical solutions business.
Associate Director, Medical Strategy – Innovation Lead
Medical strategy leader shaping Hematology Medical Affairs for BeOne, a global oncology company developing affordable cancer treatments in Germany. Driving evidence generation, partnerships and launch readiness.