IT Executive Director, R&D and CMC
4 weeks ago
Key Responsibilities:
Strategic Leadership:
- Develop and execute IT strategies aligned with R&D, CMC, and Quality objectives, supporting the overall business strategy.
- Collaborate with cross-functional teams including R&D, Clinical Development, Manufacturing, Regulatory, and Quality to ensure IT initiatives enhance and optimize R&D, Clinical Development, CMC, and Quality processes and operations.
- 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.
- Coordinate and integrate with external CMO’s and labs with regard to operations, technology, and data integration and analytics
- Implement data analytics, reporting, and AI solutions to maximize information and supercharge productivity.
- Integrate various internal and external R&D and CMC data sources to speed decision-making and execution across research, clinical, manufacturing, and supply chain.
- Evaluate, select, and manage relationships with IT vendors and service providers specializing in Clinical Development, CMC, and Quality IT solutions.
- Negotiate contracts, service level agreements, and ensure vendor performance aligns with organizational objectives.
- Work closely with the Quality team to ensure IT systems supporting Quality functions comply with regulatory standards and guidelines.
- Stay abreast of evolving regulatory guidelines and industry standards, ensuring IT systems meet compliance requirements.
- Oversee both insourced and outsourced IT systems supporting R&D, CMC, and Quality functions, ensuring systems are compliant with regulatory requirements and industry best practices.
- Implement and enforce data security measures to safeguard sensitive information related to clinical development, regulatory affairs, CMC, and Quality functions.
- Build and lead high-performing IT teams supporting R&D, CMC, and Quality functions, fostering a collaborative and innovative work culture.
- Provide guidance, mentorship, and professional development opportunities to team members.
- Bachelor's degree in Information Technology, Computer Science, or a related field; advanced degree preferred.
- 15+ years of progressive leadership experience in IT with a focus on R&D, Clinical Development, CMC, and Quality in the pharmaceutical industry.
- Proven track record of successful implementation and management of IT systems supporting R&D, Clinical Development, CMC, and Quality processes.
- Strong understanding of regulatory requirements related to IT systems in a pharmaceutical environment.
- Excellent communication and stakeholder management skills.
- Strong project management skills with a focus on delivering results.
- In-depth knowledge of IT systems relevant to R&D, Clinical Development, CMC, and Quality including Veeva, CRO’s, submissions, Supply Chain, and computer systems validation
- Strategic thinking and leadership abilities.
- Excellent communication and interpersonal skills.
- Strong program management skills.
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.
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