Associate Director, IT R&D Operations

Syndax Pharmaceuticals is looking for an Associate Director, IT R&D 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 Associate Director, GxP R&D Operations, is responsible for overseeing and optimizing GxP systems within Research & Development (R&D) operations. This position ensures that critical systems supporting R&D departments such as Quality, Regulatory, Clinical, Supply Chain & Safety run efficiently, securely, and in full compliance with applicable regulatory requirements. The role includes driving continuous system improvements, strategic design and integration, risk management, and cross-functional collaboration to meet business objectives.

Key Responsibilities:  

• System Operations & Optimization: As the Associate Director, you will oversee the continuous operation, maintenance, user administration and performance of GxP systems with a focus on Veeva Vault and other non-Veeva applications. This responsibility includes ensuring high system reliability, compliance with regulatory standards, and the integrity of all data processed within these systems. You will take a proactive approach in monitoring system performance, anticipating issues, and addressing them before they affect operations. Additionally, you will troubleshoot system issues, collaborating with vendors and key stakeholders to resolve challenges swiftly and effectively. A key part of this role will be maintaining system configurations that align with business needs while adhering to industry-specific regulatory requirements.

• Solution Design & Integration: In this capacity, you will be responsible for identifying existing gaps in the system infrastructure and ensuring seamless integration of R&D and GxP systems to streamline operations. Providing technical leadership throughout the entire design process, you will continuously enhance these systems to maximize efficiency. Collaboration with cross-functional teams will be crucial as you work together to create solutions that drive operational excellence.

• Compliance, Security & Governance: A core aspect of your role will be to maintain the highest standards of data integrity, security, and regulatory compliance within all R&D systems. You will implement and enforce robust data governance practices, ensuring that all activities comply with GxP regulations. Developing and maintaining Standard Operating Procedures (SOPs) for system usage will be essential to guarantee adherence to regulatory standards. You will also be responsible for providing ongoing training and support to system users, ensuring that they stay informed of compliance requirements. Additionally, your role will involve preparing and maintaining comprehensive documentation to ensure audit and inspection readiness.

• Change & Risk Management: You will take charge of the Change Management Board, overseeing the evaluation, documentation, and approval of any changes made to GxP systems and processes. Your leadership will ensure that changes are communicated transparently to all stakeholders and are well-documented. You will foster a culture of effective change management, working to minimize disruptions and ensure smooth transitions during system upgrades and changes. As part of this responsibility, you will also be tasked with identifying and managing potential risks associated with system changes to safeguard ongoing operations.

• Cross-Functional Leadership & Collaboration: In this role, you will manage a high-performing cross functional team, nurturing a culture of innovation, continuous improvement, and professional development. You will provide guidance team members & vendors, ensuring that they are well-equipped to contribute to the success of key projects. 

Desired Experience/Education and Personal Attributes: 

• A Bachelor's or Master's degree in Information Technology, Computer Science, or a related field.
• At least 8 years of experience in managing GxP systems, with a minimum of 3 years in a leadership capacity.
• Deep knowledge of regulatory frameworks (GxP, 21 CFR Part 11, EU Annex 11) and their application to system operations.
• Proven success in system integrations and process optimization within R&D or clinical operations environments.
• Solid experience in data governance, system security, and maintaining compliance in highly regulated settings.
• Strong project management, organizational, and problem-solving abilities.
• Excellent communication and leadership skills with experience in working collaboratively across various functional teams.

Location: Syndax’s corporate office is in New York, NY.

Syndax offers a total compensation and rewards package that is among the most competitive in the industry. Base pay is just one element of our package and is determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity. Our overall package also includes an equity offering, annual target bonuses, and an outstanding benefits program. The anticipated annualized salary range for this role is $175,000 - $195,000.

About Syndax:
Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies. Highlights of the Company’s pipeline include a menin inhibitor for R/R acute leukemia and a monoclonal antibody that blocks the CSF-1 receptor for chronic graft-versus-host disease. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com/ or follow the Company on X and LinkedIn.

Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

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