What are the responsibilities and job description for the Associate Director of IT Governance position at Madrigal Pharmaceuticals Corporation?
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 Governance
Reporting to the Executive Director of IT R&D and Quality, the Associate Director of IT Governance will play a pivotal role in ensuring sustainable compliance in Madrigal's approach to managing, implementing and optimizing the overall digital technology programs across the organization. Your responsibilities will span across multiple regulatory domains in the digital space including but not limited to GxP, GDPR, PII, and SOX. You will collaborate cross-functionally within the Madrigal IT Organization as well as business functions such as Legal, HR, Finance, R&D, CMC, and Quality to ensure the seamless compliant operation of our IT systems and services. This position requires a seasoned life sciences professional that ideally has a strong GxP Quality and technology background, modern and adaptable views on computer system validation, and demonstrated passion for emerging technology.
Position Responsibilities:
1. IT Governance
- Maintain the Technology Compliance Framework aligned with global regulations, organizational risks, and evolving guidance and industry standards.
- Lead implementation and maintenance of IT Policy & SOPs in support of general controls and GxP processes including validation lifecycle in collaboration with Quality.
- Collaborate with Infrastructure and CISO to enable security governance and risk management controls in mixed regulated use environment
- Implement innovative learning approaches to user community for IT compliance procedures and practices.
- Act as a liaison to for external partners to support their understanding of Madrigal technology compliance requirements
- Audit Management focal point for internal/external audits of the IT organization
- Develop and monitor key performance indicators (KPIs) to evaluate framework effectiveness and identify improvement opportunities
2. IT Lifecycle Management
- Internal consultant for validation planning for business facing applications, infrastructure, data platforms, and AI/ML with IT peers and Business Partners supporting GxP and other regulated areas
- Maintain process for System Regulatory Assessments and associated IT Inventory
- Partner with Procurement and Legal/Compliance to ensure proactive controls for software/technology onboarding and vendor management
- Collaborate with Madrigal Quality for technology related investigations, non-conformance and CAPA.
- Lead the selection, implementation, and maintenance of IT Tools for SDLC/VLC processes ( e.g. Requirement & Test Management solutions such as Veeva Validation, Kneat, Helix ALM, etc,)
- Bachelor's degree in computer science, information technology, engineering, or scientific related field
- 8-10 years of life sciences experience in leading projects from conception to completion, with a proven track record of delivering on time and within budget.
- Excellent Collaboration & Communication skills, with the ability to effectively interact with stakeholders at all levels of the organization.
- In-depth knowledge of GxP regulations related to Computer System Validation/Computer Systems Assurance, and current global technology related regulations and guidance.
- Hands on experience in technology and/or quality roles using modern, Risk Based Computer Validation approaches for typical technology stack (ERP, QMS, Doc Mgmt, Learning Management, Infrastructure, Clinical Trial, PV, etc)
- Experience in developing validation approaches for infrastructure and cloud based Platforms.
- Non-Health ministry regulatory requirements background including GDPR, PII, and SOX s is preferred
- Prior experience in validation of platforms enabling emerging technology including A&/ML is preferred
- Experience in using and/or implementing System Development Lifecycle and testing tools is preferred (Example: Veeva Validatoin, KNEAT, HP ALM, QTest, JIRA for GxP use, etc.)
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 Governance 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.
