Director, IT R&D Technology Platforms and Operations

Syndax Pharmaceuticals • New York, NY

2h • Remote

About The Position

Syndax Pharmaceuticals is looking for a Director, IT R&D Technology Platforms and Operations
At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies.
The Role:
The Director, IT R&D Technology Platforms and Operations is responsible for overseeing and optimizing operational R&D technology platforms, spanning both regulated and non-regulated systems across all of R&D. This position ensures that critical production GxP systems supporting all R&D departments and functions, not limited to groups such as Research, Quality, Clinical, Supply Chain and Safety, run efficiently, securely, and in compliance with applicable regulatory requirements where in scope. The role focuses on steady state system operations, continuous optimization, service governance, risk management, and cross functional collaboration to meet business objectives and maintain audit and inspection readiness where applicable. This role owns inspection readiness for in scope platforms, ensuring continuous audit and inspection preparedness through effective governance, documentation, and operational controls. This role reports to Executive Director in IT.

Requirements

• A Bachelor’s or Master’s degree in Information Technology, Computer Science, or a related field.
• At least 10 years of experience supporting and operating production enterprise systems, with experience in regulated environments and a minimum of 5 years in a leadership capacity.
• Demonstrated experience owning or directly supporting audit and inspection readiness, including participation in at least one regulatory inspection and respond to inspection observations.
• Strong understanding of applicable regulatory frameworks and expectations (for example 21 CFR Part 11, EU Annex 11) and how they apply to production system operations and compliance controls.
• Proven success in system integrations, operational optimization, and service governance within R&D or clinical operations environments.
• Solid experience in data governance, system security, and maintaining compliance controls in highly regulated settings, including secure file transfer and exchange patterns.
• Strong change and release management capabilities with a focus on production system stability and risk-based decision making.
• Experience partnering with business stakeholders on analytics and executive reporting support, with an understanding of data governance and data quality practices.
• Strong vendor partnership, negotiation, and commercial management experience, including licensing and renewals and cross functional coordination with Procurement and Finance.
• Excellent communication and leadership skills with experience working collaboratively across R&D, Quality, Regulatory, Clinical, Supply Chain and Safety teams.

Responsibilities

• System Operations and Optimization: As the Director, you will oversee the continuous operation, platform lifecycle management, role-based access administration, and operational oversight, and performance of GxP production systems with a focus on Veeva Vault and other non-Veeva applications. This responsibility includes ensuring high system reliability, appropriate compliance controls, and the integrity of all data processed within these platforms. You will take a proactive approach in monitoring system performance, anticipating issues, and addressing them before they affect business operations. A key part of this role will be overseeing platform configuration and configuration governance, periodic reviews and operational practices that align with business needs while adhering to applicable regulatory expectations.
• Solution Design and Integration: In this capacity, you will identify gaps and operational pain points within the GxP production systems ecosystem and translate them into prioritized enhancements that improve performance, usability, and business efficiency. You will provide technical leadership for production focused design and integration decisions, ensuring changes support streamlined processes and secure, reliable data flow across R&D and connected functions. You will work closely with cross-functional partners to define requirements, evaluate options, and deliver improvements through a controlled and compliant change process.
• Compliance, Security and Governance: A core aspect of your role will be to maintain strong standards of data integrity, security, and regulatory compliance within all in-scope production systems across R&D. You will implement and enforce robust governance practices, ensuring that operational activities align with applicable requirements such as 21 CFR Part 11 and EU Annex 11 where relevant. Developing and maintaining Standard Operating Procedures (SOPs), work instructions, and training materials for platform operations, validated state maintenance where applicable, data integrity controls, and regulated GxP procedures will be essential to support compliance expectations. You will also be responsible for ensuring ongoing training and support to system users, and for preparing and maintaining documentation required for audit and inspection readiness, including evidence for access controls, audit trails, periodic reviews, and validation documentation where applicable. You will partner with Quality to maintain continuous inspection readiness and lead responses to system related audit and inspection observations.
• Change and Risk Management: You will lead the Change Management Board, overseeing the evaluation, documentation, and approval of changes to GxP production systems, including releases, configuration updates, patches, integrations, and vendor delivered updates. Your leadership will ensure that changes are risk assessed, tested, validated where required, documented, and communicated transparently to all stakeholders. You will foster a culture of effective change management to minimize disruption and ensure smooth transitions during operational upgrades and releases. As part of this responsibility, you will identify and manage risks associated with operating and changing production systems to safeguard business continuity and compliant operations.
• Cross Functional Leadership and Collaboration: In this role, you will work closely with cross functional teams and system stakeholders to ensure alignment on priorities, service performance, release readiness, and operational improvements across R&D technology platforms. You will serve as a senior IT partner to business and quality stakeholders, facilitating decision making, ensuring transparent communication, and enabling consistent operational execution across supported functions.
• Data Transfer Ownership and Secure File Exchange: Own the operational governance, reliability, and compliance controls for production data transfers across the R&D technology landscape. Lead oversight of secure file exchange mechanisms, including the Egnyte GxP SFTP capability, ensuring standardized intake and provisioning, role-based access, audit trail expectations, retention practices, and validated state maintenance where applicable. Partner with Quality and system owners to ensure data transfer requirements are documented, risk assessed, and monitored, and that issues or failures are triaged and resolved quickly to protect business continuity and data integrity.
• R&D Analytics Enablement and Leadership Reporting: Partner with R&D teams to enable reporting that supports R&D decision making. Ensure reliable, governed access to data from production systems to support dashboards, metrics, and executive reporting, with appropriate data quality, security, and compliance controls. Provide operational support for reporting and analytics initiatives, including troubleshooting data issues, enabling access, and supporting enhancements to existing reporting capabilities.
• Vendor Partnership and Management: Own strategic partnerships with key platform vendors and service providers supporting R&D technology platforms. Manage vendor performance, support models, and commercial lifecycle activities, including licensing and renewals, to ensure continuity of service, appropriate coverage, and alignment to business needs. Partner with Procurement and Finance to plan renewals, validate entitlements and usage, execute contracting activities, and maintain accurate vendor and license documentation. Maintain strong vendor relationships and escalation paths to protect operational stability and ensure delivery against service expectations.
• Periodic Reviews and Operational Assurance: Own and execute periodic reviews across all R&D technology platforms to ensure ongoing operational fitness, compliance posture where applicable, and alignment to business needs. This includes coordinating scheduled reviews of access, audit trails where in scope, system configurations, integrations, vendor support performance, and platform health metrics, and ensuring review outcomes are documented and any required actions are tracked to completion.

What This Job Offers

• Job Type: Full-time
• Career Level: Director