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’s Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.
All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate’s qualifications, skills, education, experience, business needs and market demands. The base salary range for this position is $157,000 - $191,000 per year.
All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization. Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws. We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact [email protected]. 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. Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site. Please be aware that we have received 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. 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 or on behalf of Madrigal, we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to [email protected].
Top Skills
What We Do
Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a clinical-stage biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), a liver disease with high unmet medical need. Madrigal’s lead candidate, resmetirom, is a once daily, oral, thyroid hormone receptor (THR)-β selective agonist that is designed to target key underlying causes of NASH in the liver. Resmetirom is currently being evaluated in two Phase 3 clinical studies, MAESTRO-NASH and MAESTRO-NAFLD-1, designed to demonstrate multiple benefits in patients with NASH. For more information, visit www.madrigalpharma.com
