Sr Director, Data Management and Clinical Programming
Denali Therapeutics
4 months ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Senior Director of Data Management & Clinical Programming
Key Accountabilities / Core Job Responsibilities
- Provide strategic leadership and development for Data Management (DM) and Clinical Programming (CP) teams across the full data lifecycle
- Oversee end-to-end DM and CP deliverables from study start-up through database lock and Clinical Study Report, ensuring quality, timeliness, and compliance
- Drive the evolution of DM and CP strategies, processes, standards, and capabilities to enhance efficiency and scalability
- Lead studies, projects, and functional initiatives to achieve quality, timeline, and budget objectives, including resource planning
- Provide oversight of CROs and vendors to ensure performance, quality, and adherence to SOPs, GCP, and regulatory requirements
- Advance data standards (e.g., CDISC/SDTM) and champion process and technology improvements
- Identify, assess, and proactively manage risks at both functional and study levels
- Communicate effectively with stakeholders and senior leadership to enable informed decision-making
- Build and maintain strong cross-functional partnerships to support seamless data delivery
- Align departmental priorities with corporate objectives and contribute to broader organizational goals
- Represent DM and CP in internal and external working groups and strategic initiatives
- Lead talent management activities, including hiring, performance management, development, and training compliance
Qualifications & Skills (Requirements)
- BA/BS in relevant field
- 12+ years of relevant industry experience with 10+ years management experience
- Effective organizational and communication skills
- Technologically savvy
- Thorough knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, UAT, medical coding, and the drug development process
- Strong experience and knowledge in the application of data standards and clinical programming (R, SAS)
- Excellent supervisory, problem solving, negotiation and organizational skills
- Knowledge and understanding of non-CRF data flow, transfer, and integration
- Thorough knowledge of the database development process and DM lifecycle for non-interventional/exploratory and Phase I-IV studies, including pivotal, blinded, and randomized trials
- Previous relevant EDC experience required
- Strong team building and resource allocation experience
- Composure and strong conflict management skills
- Prior experience managing vendors and CROs
Benefits / Compensation
- Salary range: $245,000.00 to $318,000.00
- Competitive total rewards package including 401(k), healthcare coverage, and ESPP (plus other benefits)
Application Instructions
- Learn more and apply: https://www.denalitherapeutics.com/careers
Key Accountabilities / Core Job Responsibilities
- Provide strategic leadership and development for Data Management (DM) and Clinical Programming (CP) teams across the full data lifecycle
- Oversee end-to-end DM and CP deliverables from study start-up through database lock and Clinical Study Report, ensuring quality, timeliness, and compliance
- Drive the evolution of DM and CP strategies, processes, standards, and capabilities to enhance efficiency and scalability
- Lead studies, projects, and functional initiatives to achieve quality, timeline, and budget objectives, including resource planning
- Provide oversight of CROs and vendors to ensure performance, quality, and adherence to SOPs, GCP, and regulatory requirements
- Advance data standards (e.g., CDISC/SDTM) and champion process and technology improvements
- Identify, assess, and proactively manage risks at both functional and study levels
- Communicate effectively with stakeholders and senior leadership to enable informed decision-making
- Build and maintain strong cross-functional partnerships to support seamless data delivery
- Align departmental priorities with corporate objectives and contribute to broader organizational goals
- Represent DM and CP in internal and external working groups and strategic initiatives
- Lead talent management activities, including hiring, performance management, development, and training compliance
Qualifications & Skills (Requirements)
- BA/BS in relevant field
- 12+ years of relevant industry experience with 10+ years management experience
- Effective organizational and communication skills
- Technologically savvy
- Thorough knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, UAT, medical coding, and the drug development process
- Strong experience and knowledge in the application of data standards and clinical programming (R, SAS)
- Excellent supervisory, problem solving, negotiation and organizational skills
- Knowledge and understanding of non-CRF data flow, transfer, and integration
- Thorough knowledge of the database development process and DM lifecycle for non-interventional/exploratory and Phase I-IV studies, including pivotal, blinded, and randomized trials
- Previous relevant EDC experience required
- Strong team building and resource allocation experience
- Composure and strong conflict management skills
- Prior experience managing vendors and CROs
Benefits / Compensation
- Salary range: $245,000.00 to $318,000.00
- Competitive total rewards package including 401(k), healthcare coverage, and ESPP (plus other benefits)
Application Instructions
- Learn more and apply: https://www.denalitherapeutics.com/careers