Senior IT Manager - Regulatory, Safety and PSC (Pharmaceutical Supply Chain)

Exelixis Alameda, CA $168,500 - $239,500
Full Time Senior Level 7+ years

Posted 3 weeks ago

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About 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

AWS * Azure * Agile * Scrum * Kanban * HIPAA * GDPR * CRM systems * LIMS * GxP * Veeva * CTMS * EDC * LabWare LIMS * Tracelink *

* Required skills

Benefits

Life Insurance
Dental coverage
Opportunity to purchase company stock
Up to 10 sick days throughout the calendar year
Disability Insurance
Vision coverage
401(k) plan with generous company contributions
15 accrued vacation days in first year
Flexible spending accounts
17 paid holidays
Group medical coverage
Long-term incentives
Company-wide winter shutdown in December

About Exelixis

Healthcare
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