Associate Director, Clinical Programming & Clinical Data Management (CDM)

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.

Denali Therapeutics is seeking an Associate Director, Clinical Programming & Clinical Data Management within Clinical Data Management. This position will provide strategic leadership and oversight of data management and programming deliverables across Denali’s clinical portfolio. This role will partner closely with Biostatistics, Data Science, and Clinical Operations to ensure high-quality, submission-ready data that supports regulatory filings and accelerates drug development.

The Associate Director will lead a team of CROs, FSPs, and internal staff, driving adoption of standards, governance, and innovation while ensuring compliance with regulatory expectations. This role is critical to ensuring the seamless integration of CDM and Clinical Programming activities. This individual will also independently perform/oversee tasks related to programming outputs and report setup, as well as processing and cleaning clinical trial data, following all applicable standard and study-specific procedures.

Key Accountabilities/Core Job Responsibilities

• Develop and execute strategy for CDM and Clinical Programming functions in alignment with corporate goals.
• Represent CDM/Programming at cross-functional leadership forums and governance committees.
• Drive implementation of standards (CDISC/CDASH/SDTM/ADaM) and compliance with ICH, GCP, FDA/EMA, and 21 CFR Part 11 requirements.
• Contribute to departmental policies, SOPs, and infrastructure projects, champion process improvements and innovation.
  
  

Clinical Data Management Oversight

• Serve as CDM lead for assigned programs or therapeutic areas.
• Oversee vendor execution of database design, testing, cleaning, reconciliation, and lock activities.
• Review and approve key CDM deliverables (CRF design, DMPs, edit checks, reconciliation plans, coding, data transfer agreements).
• Ensure high-quality, inspection-ready data to support study milestones and regulatory submissions.
  
  

Clinical Programming Oversight

• Provide oversight for programming deliverables including edit checks, data review listings, reconciliation reports, and analysis-ready datasets.
• Ensure consistent use of programming standards and validation procedures across studies.
• Partner with Biostatistics to align programming deliverables with analysis needs.
• Evaluate and implement tools and technologies to improve programming efficiency and quality.
  
  

Vendor & Resource Management

• Manage CROs, FSPs, and other external partners; ensure performance against timelines, budgets, and quality standards.
• Allocate internal and external resources effectively across multiple studies and priorities.
• Provide mentorship, training, and guidance to staff and functional partners.
  
  

Qualifications/Skills

• BA/BS or higher in life sciences, computer science, or a health-related field.
• 7+ years of combined experience in Clinical Data Management and Clinical Programming, including at least 5 years in a lead or oversight role.
• Proven expertise managing outsourced vendor/FSP models in a global environment.
• Deep knowledge of EDC systems (e.g., Medidata RAVE, Veeva CDMS/RTSM) and programming languages (e.g., SAS, R, Python).
• Strong understanding of CDISC standards (CDASH, SDTM, ADaM) and regulatory requirements (ICH/GCP, FDA/EMA, GDPR, 21 CFR Part 11).
• Experience in CNS/Neurodegenerative trials highly preferred.
• Strong leadership, interpersonal, and communication skills with proven ability to manage multiple priorities in a fast-paced environment.
  
  

Salary Range: $184,000.00 to $218,000.00 . 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.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.