Head of Clinical Data Management & Strategy

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

Job summary

Denali Therapeutics is seeking a Senior Director of Clinical Data Management to lead CDM activities across multiple therapeutic areas and manage a team of managers and CDAs. You will drive data standards, vendor management, and use of EDC systems while ensuring FDA/EMA regulatory compliance and high-quality data delivery for pivotal trials.

The role requires 10+ years in CDM with 5+ years of people management, strong problem-solving, and collaboration with cross-functional teams to optimize

Qualifications

• BA/BS or higher in math, science, or health-related field with 10+ years of CDM experience.
• Minimum 5+ years of people-management experience.
• Strong experience with data standards, EDC systems, and managing vendors/CROs.
• Thorough knowledge of FDA regulations, ICH-GCP, SDTM, CDISC, and the drug development process.
• Experience supporting regulatory submissions and audits is preferred.

Responsibilities

• Lead CDM activities across multiple therapeutic areas and molecules.
• Manage a team of Managers and Clinical Data Associates.
• Drive CDM strategy and implementation of new data standards and tools.
• Ensure compliance with FDA/EMA regulatory standards and audits.
• Oversee vendor performance and EDC system implementations.

Skills

CDM leadership

Vendor management

Regulatory knowledge

Data standards

EDC systems

Team leadership

Education

BA/BS in science/health

Tools

EDC systems

Job description

Denali Therapeutics is seeking a Senior Director of Clinical Data Management to lead CDM activities across multiple therapeutic areas and manage a team of managers and CDAs. You will drive data standards, vendor management, and use of EDC systems while ensuring FDA/EMA regulatory compliance and high-quality data delivery for pivotal trials.

The role requires 10+ years in CDM with 5+ years of people management, strong problem-solving, and collaboration with cross-functional teams to optimize