Sr Director, Data Management and Clinical Programming

Denali Therapeutics•South San Francisco, CA

1d•$245,000 - $318,000

About The Position

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. The Senior Director of Data Management & Clinical Programming provides strategic and operational leadership within an outsourced model, overseeing data management and clinical programming across Phase I–IV and non-interventional/exploratory studies. This role is accountable for the timely delivery of high-quality, compliant clinical data to support study execution and regulatory submissions. This leader develops high-performing teams, ensures vendor excellence, and drives data standards and innovation to enhance quality, efficiency, and scalability.

Requirements

BA/BS in relevant field
12+ years of relevant industry experience with 10+ years management experience
Requires effective organizational and communication skills
Technologically savvy – quickly picks-up on new information, standards, regulations, tools, methods or software as it relates to position and profession
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, SAAS)
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 understanding of DM lifecycle associated with 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
Exhibits composure and strong conflict management skills
Prior experience managing vendors and CROs

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