Senior Director, Clinical Data Management

Denali Therapeutics Inc; South San Francisco (CA); On-site; USD 212,000 - 276,000; Full time

Benefits offered by this job

401k

Healthcare coverage

ESPP

Broad range of other benefits

Job summary

Denali Therapeutics Inc. is a biotechnology company advancing a diverse portfolio of therapies with a focus on delivering breakthrough treatments to patients.

This role leads clinical data management across multiple therapeutic areas, driving data quality, standards, and regulatory readiness. TheHead of CDM will manage a team of managers and CDAs, implement new tools and processes, and collaborate with Clinical Programming, Data Science, Biostatistics, and Operations to meet study deliverables

Qualifications

• BA/BS or higher in math, science, or health-related field; typically requires 10+ years of CDM experience, including 5+ years of people-management.
• Strong experience with data standards, EDC systems, and managing vendors/CROs.
• Thorough knowledge of FDA regulations, ICH-GCP, SDTM, CDISC, database development, UAT, medical coding, and the drug development process.
• Prior experience supporting regulatory submissions and regulatory inspections is strongly preferred.

Responsibilities

• Provide leadership and oversight for clinical data management activities across multiple therapeutic areas and molecules.
• Lead CDM activities at the project or study level, as needed.
• Manage a team of Managers and Clinical Data Associates, ensuring effective support for complex data management needs.
• Direct and guide team through DM lifecycle for P1-P3 studies, including pivotal, blinded, and randomized trials.
• Lead annual goal setting and growth planning for direct report(s) and ensure training compliance.
• Drive CDM organizational strategy and lead implementation of change initiatives to improve processes, systems and productivity.
• Collaborate with Clinical Programming, Data Science, Clinical Operations, Biostatistics and other departments to meet project deliverables.
• Lead initiatives to improve data management processes and implement advanced tools to increase efficiency and reduce errors.
• Ensure compliance with FDA, EMA, and other global standards and support regulatory audits and inspections.
• Anticipate internal resources, manage external costs, and ensure long-term resource allocation for data management functions.
• Oversee vendor performance and the implementation of new systems and tools (EDC) to enhance productivity.
• Ensure study documentation and data deliveries meet SOPs and GCPs.

Skills

CDM leadership

Vendor management

Regulatory knowledge

Team leadership

Education

BA/BS or higher in math, science, or health-related field

Tools

EDC systems

CDISC data standards

Job description

Denali Therapeutics Inc. is a biotechnology company advancing a diverse portfolio of therapies with a focus on delivering breakthrough treatments to patients.

This role leads clinical data management across multiple therapeutic areas, driving data quality, standards, and regulatory readiness. TheHead of CDM will manage a team of managers and CDAs, implement new tools and processes, and collaborate with Clinical Programming, Data Science, Biostatistics, and Operations to meet study deliverables