Director, Clinical Data Management & Strategy

Denali-Therapeutics; South San Francisco (CA); Vor Ort; USD 212.000 - 276.000; Vollzeit

Benefits dieser Stelle

401k

Healthcare coverage

ESPP

Zusammenfassung

Denali Therapeutics Inc. seeks a senior leader to oversee clinical data management across multiple therapeutic areas, ensuring regulatory compliance and high-quality data deliverables.

You will manage a team of managers and clinical data associates, collaborating with Clinical Programming, Data Science, Biostatistics and Clinical Operations to drive innovative tools and processes enabling successful trials from P1 to P3.

Qualifikationen

• 10+ years of CDM experience in biotech/pharma.
• 5+ years of people management experience.
• Strong knowledge of FDA regulations, ICH-GCP, SDTM/CDISC.
• Experience with data standards, EDC systems, and managing CROs/vendors.
• Experience supporting regulatory submissions and inspections.

Aufgaben

• Provide leadership for CDM activities across multiple therapeutic areas and molecules.
• Lead CDM activities at project or study level (P1-P3), including pivotal, blinded, and randomized trials.
• Direct and guide team through DM lifecycle; annual goals and growth planning.
• Drive CDM strategy and implement data standards and tools to improve efficiency.
• Oversee vendor performance and EDC system implementations; ensure quality and compliance.

Kenntnisse

CDM leadership

People management

Regulatory knowledge

Data standards

EDC systems

Vendor management

FDA/ICH-GCP

SDTM/CDISC

Regulatory submissions

Ausbildung

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

Tools

EDC platforms

Jobbeschreibung

Denali Therapeutics Inc. seeks a senior leader to oversee clinical data management across multiple therapeutic areas, ensuring regulatory compliance and high-quality data deliverables.

You will manage a team of managers and clinical data associates, collaborating with Clinical Programming, Data Science, Biostatistics and Clinical Operations to drive innovative tools and processes enabling successful trials from P1 to P3.