Associate Director of IT R&D
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.
- 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
- 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.
- 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.
- 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.
- 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
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.
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.
Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.
Please be aware that we are currently receiving numerous reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Interviews with Madrigal are conducted via the Zoom platform.
Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for Madrigal we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.