Senior Manager, IT, R&D Applications (Contractor)

Role Summary

Senior Manager, IT, R&D Applications (Contractor) leads IT support for core R&D business applications across Development and Research teams, including QA, Clinical Operations, Biometrics, Medical Affairs, and Regulatory functions. Responsible for the implementation, maintenance, and ongoing support of SaaS technologies used by these functions to enhance efficiency and drive business outcomes. Reports to the Director, R&D Business Partner. Based in South San Francisco, CA.

Responsibilities

• Act as an application technology partner to R&D business owners, ensuring technology solutions align with departmental objectives and business functionality.
• Translate business needs into clear technical requirements by maintaining regular engagement with business owners across the R&D department.
• Proactively identify opportunities where technology, data, or process improvements can drive efficiency, reduce risk, or enhance operational outcomes.
• Lead and gather business requirements, processes, and drive implementation of change requests.
• Oversee the design, configuration, implementation, and maintenance of relevant R&D applications.
• Drive continuous improvement initiatives to optimize application performance and enhance user experience.
• Collaborate with cross-functional teams to integrate applications with other enterprise systems.
• Lead the R&D application upgrades and implementations as the IT System owner.
• Manage and oversee user administration, workflow development, operational support, troubleshoot, and resolve R&D business application production issues.
• Ensure IT policies and procedures are communicated to all personnel and compliance is maintained.
• Establish/maintain relationships with internal business owners, technology teams and external technology vendors.
• Support Computer System Validation processes for GxP applications.

Qualifications

• Bachelor’s degree in Computer Information Systems, Business Administration or related discipline.
• 8+ years of industry experience in commercial Biotech, Pharma or Life Sciences Company.
• Knowledge of Drug Development process and sub-process within each department, with an emphasis on Biometrics, QA, and Clinical Operations.
• Experience developing relationships with and ensuring the appropriate participation of key stakeholders and internal customers.
• Extensive knowledge of Cloud Systems in a Life Sciences Environment.
• Experience with implementing, integrating, and managing R&D software solutions such as Veeva Vault (QualityDocs, LMS, Promomats, Medical CRM), SAS, DocuSign Part 11, PhelxGlobal eTMF.
• Strong working knowledge of System Development Life Cycle methodologies in project delivery.
• Extensive knowledge of Regulatory requirements and standards (FDA 21CFR Part 11).
• Exceptional vendor management skills.
• Superior organization, planning, and project management skills.
• Ability to work in a small, fast-paced IT team.
• Ability to distill technical concepts and present to a non-technical audience.
• Accuracy and responsibility, ability to work with minimal supervision.
• Excellent customer service skills and ability to demonstrate a passion to assist and add value to department and company.
• Excellent analytical, troubleshooting, and decision-making skills.
• Proven ability to perform effectively under conditions such as project changes, tight deadlines, limited resources.