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

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).

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

Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.

Full-time employees are eligible for bonus, equity and comprehensive benefits including flexible paid time off (PTO), medical, dental, vision and life/disability insurance. We also offer Voluntary benefits like life insurance, pre-paid legal and supplemental insurance. In additi