What are the responsibilities and job description for the Associate Director, IT R&D position at Madrigal Pharmaceuticals?
It's fun to work in a company where people truly BELIEVE in what they're doing!
We're committed to bringing passion and customer focus to the business.
ABOUT MADRIGAL: Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis. ROLE OVERVIEW: Associate Director of IT R&D Reporting to the Executive Director of IT R&D and Quality, as the Associate Director of IT R&D, you will play a pivotal role in managing, implementing and optimizing the digital technology programs within the Research & Development, CMC, and Quality functions of our pharmaceutical organization. This position requires a seasoned technology professional with a strong understanding of R&D, Clinical Development, Regulatory Affairs, CMC, and/or Quality processes in the pharmaceutical industry. The ideal candidate will partner closely with functional leadership in these areas to drive technological innovation, sustainable compliance and operational excellence. POSITION RESPONSIBILITIES: 1. R&D and Clinical Development Systems: * Lead the selection, implementation, and maintenance of IT systems supporting Research, Clinical Development, Clinical Trial Management, Electronic Data Capture (EDC), Medical Writing, etc. * Ensure seamless integration and optimization of clinical trial technologies to support efficient and compliant trial execution. * Manage IT systems supporting Regulatory Affairs, ensuring compliance with regulatory requirements for submissions, document management, and regulatory intelligence. * Implement strategies to enhance regulatory processes through technology, contributing to successful regulatory submissions. 2. CMC and Quality Systems: * Lead the delivery and support of IT solutions into CMC and Quality processes, ensuring alignment with manufacturing, Quality, and supply chain across internal and external operations. * Identify opportunities to leverage technology to optimize CMC and Quality operations, driving efficiency and compliance when leveraging outsourcing partners. * Coordinate and integrate with external CMO's and labs technology, data integrations and analytics 3. Data Analytics/Reporting/AI-ML Enablement: * Implement data analytics, reporting, and AI solutions to maximize information and supercharge productivity. * Integrate various internal and external data sources to speed decision-making and execution across research, clinical, manufacturing, and quality. 4. Vendor Management: * Evaluate, select, and manage relationships with IT vendors and service providers specializing in Clinical Development, CMC, and Quality IT solutions. * Oversee both insourced and outsourced IT systems ensuring systems are compliant with regulatory requirements and industry best practices. * Negotiate contracts, service level agreements, and ensure vendor performance aligns with organizational objectives. 5. Quality and Compliance: * Work closely with the Quality Unit and IT Governance to ensure systems have applicable preventative and detective controls to safeguard sensitive information and comply with regulatory standards and guidelines (e.g. GxP, GDPR, and/or PII). * 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. QUALIFICATIONS AND SKILLS REQUIRED: * Bachelor's degree in computer science, information technology, engineering, or a technology or scientific related field. * 8 - 10 years of experience in IT delivery management and business partner roles in life science organizations * Strong technical program/project management skills with experience leading IT projects from conception thru go-live and ongoing operations, with a proven track record of delivering on time and within budget. * Demonstrated knowledge of supporting technology in a GxP environment and leading system teams thru Computer System Validation (CSV) lifecycle is required * Excellent collaboration and communication skills, with the ability to effectively interact with stakeholders at all levels of the organization * Experience with Cloud /Software-as-a-service solutions within the pharmaceutical industry is preferred * Experience implementing emerging technology including A&/ML is preferred Join Our Team: If you are a seasoned IT professional with a passion for technology and a desire to drive innovation, we encourage you to apply for the position of Associate Director of IT R&D at Madrigal. Join us in shaping the future of our IT infrastructure and making a meaningful impact on our organization's success. COMPENSATION: Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.
We're committed to bringing passion and customer focus to the business.
ABOUT MADRIGAL: Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis. ROLE OVERVIEW: Associate Director of IT R&D Reporting to the Executive Director of IT R&D and Quality, as the Associate Director of IT R&D, you will play a pivotal role in managing, implementing and optimizing the digital technology programs within the Research & Development, CMC, and Quality functions of our pharmaceutical organization. This position requires a seasoned technology professional with a strong understanding of R&D, Clinical Development, Regulatory Affairs, CMC, and/or Quality processes in the pharmaceutical industry. The ideal candidate will partner closely with functional leadership in these areas to drive technological innovation, sustainable compliance and operational excellence. POSITION RESPONSIBILITIES: 1. R&D and Clinical Development Systems: * Lead the selection, implementation, and maintenance of IT systems supporting Research, Clinical Development, Clinical Trial Management, Electronic Data Capture (EDC), Medical Writing, etc. * Ensure seamless integration and optimization of clinical trial technologies to support efficient and compliant trial execution. * Manage IT systems supporting Regulatory Affairs, ensuring compliance with regulatory requirements for submissions, document management, and regulatory intelligence. * Implement strategies to enhance regulatory processes through technology, contributing to successful regulatory submissions. 2. CMC and Quality Systems: * Lead the delivery and support of IT solutions into CMC and Quality processes, ensuring alignment with manufacturing, Quality, and supply chain across internal and external operations. * Identify opportunities to leverage technology to optimize CMC and Quality operations, driving efficiency and compliance when leveraging outsourcing partners. * Coordinate and integrate with external CMO's and labs technology, data integrations and analytics 3. Data Analytics/Reporting/AI-ML Enablement: * Implement data analytics, reporting, and AI solutions to maximize information and supercharge productivity. * Integrate various internal and external data sources to speed decision-making and execution across research, clinical, manufacturing, and quality. 4. Vendor Management: * Evaluate, select, and manage relationships with IT vendors and service providers specializing in Clinical Development, CMC, and Quality IT solutions. * Oversee both insourced and outsourced IT systems ensuring systems are compliant with regulatory requirements and industry best practices. * Negotiate contracts, service level agreements, and ensure vendor performance aligns with organizational objectives. 5. Quality and Compliance: * Work closely with the Quality Unit and IT Governance to ensure systems have applicable preventative and detective controls to safeguard sensitive information and comply with regulatory standards and guidelines (e.g. GxP, GDPR, and/or PII). * 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. QUALIFICATIONS AND SKILLS REQUIRED: * Bachelor's degree in computer science, information technology, engineering, or a technology or scientific related field. * 8 - 10 years of experience in IT delivery management and business partner roles in life science organizations * Strong technical program/project management skills with experience leading IT projects from conception thru go-live and ongoing operations, with a proven track record of delivering on time and within budget. * Demonstrated knowledge of supporting technology in a GxP environment and leading system teams thru Computer System Validation (CSV) lifecycle is required * Excellent collaboration and communication skills, with the ability to effectively interact with stakeholders at all levels of the organization * Experience with Cloud /Software-as-a-service solutions within the pharmaceutical industry is preferred * Experience implementing emerging technology including A&/ML is preferred Join Our Team: If you are a seasoned IT professional with a passion for technology and a desire to drive innovation, we encourage you to apply for the position of Associate Director of IT R&D at Madrigal. Join us in shaping the future of our IT infrastructure and making a meaningful impact on our organization's success. COMPENSATION: Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.
