Senior IT Manager - Regulatory, Safety and PSC (Pharmaceutical Supply Chain)
Posted 2 months ago Expired
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Upload Your ResumeAbout This Role
Lead a portfolio of critical digital products for Exelixis, driving strategy, development, and operational excellence to support the launch of innovative medicines. This role focuses on user experience and value delivery within a product-centric model, leading agile teams to accelerate drug discovery, development, and commercialization.
Responsibilities
- Own two or more digital products, understanding and executing their vision and strategy within digital applications (e.g., Clinical Trials, R&D Informatics, Supply Chain).
- Collaborate with business owners and stakeholders to gather user needs and drive product requirements and user stories development for assigned digital products.
- Evaluate product initiatives by assessing business value, technical feasibility, and compliance considerations.
- Own the architecture and design of one or two products, ensuring alignment with enterprise design and security standards.
- Manage product development activities across one or more digital products throughout their lifecycle using Agile practices (Scrum, Kanban).
- Draft user stories and acceptance criteria for two or more digital products.
- Collaborate with engineering, architecture, and QA teams to deliver secure, scalable, and high-quality digital applications.
- Coordinate with vendors to support product delivery timelines and operational needs across two or more digital products.
- Maintain the stability, performance, and security of digital applications in collaboration with IT operations and infrastructure teams.
- Support compliance efforts by ensuring product features and processes meet regulatory and internal standards (e.g., GxP, HIPAA, GDPR).
Requirements
- Bachelor's degree in a related discipline and 9 years of related experience; or Master's degree in mathematics or statistics or engineering and 7 years of related experience; or PhD degree in a related discipline and 5 years of related experience; or equivalent combination of education and experience
- Minimum of 5 years of experience supporting Enterprise IT enabling business functions
- Minimum of 7+ years of progressive experience in IT, focused on digital applications or product management within the life science or pharmaceutical industry
- Proven experience in leading product development teams in an agile/product-centric operating model
- Strong understanding of the drug discovery, clinical development, quality and regulatory submissions lifecycle within a pharmaceutical or biotechnology company
- Demonstrated success in defining and delivering complex digital products that drive significant business value
- Experience with regulatory frameworks and compliance in a GxP environment
Qualifications
- Bachelor’s degree in related discipline or equivalent combination of education and experience
- 7+ years of progressive experience in IT, focused on digital applications or product management within the life science or pharmaceutical industry, with a minimum of 5 years supporting Enterprise IT.
Nice to Have
- Experience with specific technologies or platforms (e.g., Veeva, LabWare LIMS, Tracelink, AWS, Azure, LIMS, EDC, CTMS, CRM systems widely used in pharma)
Skills
* Required skills