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. 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: • 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, 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 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 Salary Range: $245,000.00 to $318,000.00 .  Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.