Sr Director, Data Management and Clinical Programming

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.

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.
 

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.