Senior Manager, IT Business Anayst: R&D and Quality

Job Summary:

Drive the delivery of technology solutions and digital transformation initiatives within R&D and Quality. In this hands-on, execution-focused role, you will work closely with our R&D and Quality business partners to understand existing and emerging processes, gather and refine requirements, and help translate business needs into best-in-class technology solutions that support both current operations and future roadmap innovation. This IT lead will play a key role in ensuring systems are maintained in a compliant validated state, and deliver business value in regulated environments.

Position Specific Responsibilities:

• Lead the selection, implementation, and ongoing operations of IT systems supporting Madrigal’s R&D landscape. 
• Build relationships with R&D business areas which may include Clinical Operations, Regulatory, PV, Biostats & Data Science, Clinical Pharmacology, Medication Writing and Submissions, etc
• Ensure seamless integration and optimization of R&D technologies to support efficient and compliant execution from research to clinical trial operations to regulatory submissions.
• Implement data analytics, reporting, and AI solutions to maximize information and supercharge productivity in coordination with other specialized IT functions.
• Lead initial system validation and scalable change control approaches with internal and external  technology partners, Business owners, and Quality to ensure GxP systems remain in a compliant state
• Ensure all systems and changes follow global GxP regulatory, privacy, and compliance standards
• Manage vendor relationships across platform providers and implementation partners. Supervise contractors as necessary

Specialized Knowledge & Skills:

• Demonstrated experience in multiple R&D technology areas that may include: eTMF, Clinical Trail Management Solutions & EDC ; Scientific Data & Image Management Repositories; RIM and eCTD Publishing, PV Databases & Signal Detection, Statistical Computing, Modeling, and Simulation Environments; QMS solutions
• Excellent collaboration and  communication skills, with the ability to effectively interact with stakeholders at all levels of the organization

Educational Requirements:

Identify the educational qualifications that an employee must possess to perform the job duties and responsibilities satisfactorily.

• Bachelor’s degree in Information Technology, Engineering, Life Sciences, or related field

Experience:

Identify the minimum number of full-time experiences required in terms of years and the type of work experience an employee needs to qualify for the job.

• 7-10 + years of experience in Technology roles within the pharmaceutical industry
• IT Delivery roles supporting R&D related applications, data management solutions and integrations with CROs/CMOs
• Demonstrated knowledge of supporting technology in a GxP environment and leading system teams thru Computer System Validation (CSV) lifecycle is required
• Experience with Cloud /Software-as-a-service solutions within the pharmaceutical industry is preferred
• Experience implementing emerging technology including A&/ML is preferred