Director, IT Controls and ERP Lead

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 Director, IT Controls and ERP will play a central role in ensuring that Denali’s expanding and increasingly complex technology environment continues to support a strong, scalable internal control framework. This individual will guide the evolution of our existing IT control’s structure to meet the demands of a more integrated systems landscape, maturing processes, strengthening governance, and ensuring readiness for heightened SOX and regulatory expectations. Further, this role will lead Denali’s ERP platform strategy and operation. The lead will partner closely across the Enterprise primarily with IT, Finance, Quality and Manufacturing teams to align controls across SOX and GxP areas to ensure compliance requirements are met with an eye to building a sustainable, audit-ready environment in support of Denali’s mission.

Key Accountabilities/Core Job Responsibilities:

IT Controls:

• Own the IT portion of the SOX compliance program, partnering with the controller group in SOX planning and system and interface scoping, and oversee controls and testing related to all in-scope applications and interfaces; maintain and enhance all related documentation.

• Lead audit planning and facilitate efficient coordination with internal and external auditors and cross-functional teams; oversee ITGC and IT application control testing executed, ensuring quality, clarity, and timeliness of all evidence and supporting materials.

• Manage the remediation of all IT control deficiencies, including structured root cause analysis, documentation of severity and risk, and verification of successful, sustainable remediation; prevent recurrence through improved process or control design.

• Coordinate SOC report reviews for relevant service providers and ensure evaluations are timely, complete, and appropriately documented.

• Partner with Quality and Compliance groups to align controls across SOX and other regulatory and GxP frameworks, designing efficient, technology-enabled control structures that satisfy multiple compliance requirements without redundancy.

• Evaluate, mature, and enhance existing IT controls across SAP, Workday and all other in-scope systems, including access provisioning and monitoring, segregation of duties, change management, and interface monitoring; ensure controls remain effective and scalable as systems and integrations become more complex.

• Identify risks, inefficiencies, and opportunities for improvement across the IT controls framework; propose and implement practical, durable remediation strategies that balance compliance expectations with business realities.

• Prepare periodic updates for management, SOX leadership, and governance bodies regarding IT SOX status, key risks, progress, and remediation efforts; clearly translate technical topics for finance and business partners.

• Educate IT and system owners through training and guidance to improve understanding of SOX, ITGC/IAC responsibilities, documentation expectations, and how day-to-day IT activities support ICFR and broader regulatory requirements. 

ERP Leadership:

• Own day-to-day operations of Denali’s SAP S/4HANA landscape, ensuring stability, performance, and continuity across Finance, Supply Chain, Manufacturing, Quality, and Commercial functions.

• Serve as the primary steward of SAP change governance, driving impact assessments, coordinating cross-functional reviews, and enforcing disciplined release and transport management.

• Partner with business process owners and IT architects to triage issues, refine configurations, and guide enhancements that support a commercial-stage biotech.

• Lead SAP incident, problem, and request workflows; ensure timely resolution through internal teams and external managed service providers.

• Maintain compliance with SOX, GxP, and internal IT controls by embedding audit-ready documentation and traceability in all SAP changes.

• Continuous improvement leadership through tracking system health, optimizing integrations, and pushing for automation in monitoring, testing, and deployment activities.

Qualifications/Skills:

• Bachelors required; advanced preferred. 12+ years of industry experience and 10+ years of management experience

• 8-12 years of experience in IT audit or IT compliance

• Deep understanding of SOX, ITGCs and testing internal controls required.

• Demonstrated hands-on operational experience with SAP S/4 HANA or comparable ERP.

• Experience in the pharmaceutical and biotech industries preferred including in house manufacturing operations and supply chain.

• Experience designing or maturing controls in complex, integrated system environments (including cloud applications, APIs, and automated workflows).

• Ability to communicate effectively with highly technical IT stakeholders as well as translate complex technical concepts into clear, simple terms for leadership, Finance, and non-IT partners.

• Demonstrated ability and willingness to lead cross-functionally, influencing stakeholders across the organization to drive alignment and effective control execution.

• Strong critical thinking, structured problem solving, and ability to develop practical remediation approaches.

• Excellent written and verbal communication skills; strong documentation discipline and project management skills.

• Self-starter who can work in an autonomous fashion.

• Experience with Workday HRIS preferred.

• Big 4 IT audit experience strongly preferred. 

Salary Range: $208,000.00 to $271,000.00 .  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.