Exelixis · 5 hours ago
Associate Principal IT Product Lead - Quality and Regulatory Systems
Alameda, CA
Full-time
Onsite
Senior Level, Lead/Staff
$174K/yr - $246K/yr
6+ years expExelixis is a biotechnology company focused on launching innovative medicines for patients. The Associate Principal IT Product Lead will lead digital products critical to the company's success, driving strategy, development, and operational excellence of the digital application ecosystem while ensuring alignment with business objectives and user experience.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Support the development and execution of the vision, strategy, and roadmap for digital products within the Digital Applications job family, specifically Regulatory and Quality Applications
Partner with senior product leads and business stakeholders in Regulatory and Quality functions to gather insights, understand user needs, and translate them into clear product requirements and user stories
Contribute to market research, competitive analysis, and technology assessments to inform product planning and identify innovation opportunities
Assist in prioritizing product initiatives by evaluating business impact, technical feasibility, compliance needs, and resource constraints
Collaborate with architecture and engineering teams to ensure digital solutions are designed and built securely and in alignment with enterprise standards
Support the Principal Product Lead in mentoring Business Analysts and other digital application team members, encouraging a culture of ownership, innovation, and continuous improvement
Contribute to managing the product lifecycle from ideation through launch and post-launch optimization, applying Agile methodologies (e.g., Scrum, Kanban) to ensure efficient delivery
Assist in defining clear user stories, acceptance criteria, and product specifications that align with the product vision and business objectives
Collaborate with engineering, architecture, and quality assurance teams to help ensure timely delivery of scalable, secure, and high-quality digital applications
Coordinate with external vendors and service providers to support alignment on product roadmaps and delivery operations
Promote user-centric design by incorporating user research, usability testing, and feedback into product enhancements
Act as a key liaison between IT and business functions, helping to translate technical concepts into business language and vice versa
Build collaborative relationships with stakeholders to support alignment of product vision, priorities, and outcomes
Facilitate communication and coordination across product, business, and IT teams to support effective decision-making
Represent the product team in cross-functional discussions and contribute to strategic initiatives as needed
Support efforts to maintain the operational stability, performance, and security of digital applications in collaboration with IT operations and infrastructure teams
Assist in managing vendor relationships and third-party software solutions that support the digital application portfolio
Help ensure compliance with regulatory requirements (e.g., GxP, HIPAA, GDPR) and internal quality and security standards across product releases
Contribute to quality assurance processes to ensure product releases meet defined standards
Actively contribute to the Implementation and maintenance of robust data management & AI practices to protect sensitive information and ensure its accuracy and reliability
Track and report on key performance indicators (KPIs) to assess product success, adoption, and business impact, and support continuous improvement efforts
Qualification
Required
Bachelor's degree in related discipline and 11 years of related experience; or
Master's degree in mathematics or statistics or engineering, and 9 years of related experience
PhD degree in a related discipline and 5 years of related experience; or
Equivalent combination of education and experience
Minimum of 6 years of experience supporting Enterprise IT enabling business functions
Minimum of 8+ years of progressive experience in IT, with at least 6+ years in a leadership role focused on digital applications or product management within the life science or pharmaceutical industry
Proven experience leading product development teams in an agile/product-centric operating model is essential
Strong understanding of the drug discovery or clinical development, or commercialization lifecycle within a pharmaceutical or biotechnology company
Demonstrated success in defining and delivering complex digital products that drive significant business value
Experience with one of the mentioned specific technologies or platforms as relevant to the specific role, [e.g., SaaS platforms (Veeva Quality, Veeva RIM, Lorenz DocuBridge, ComplianceWire, Porzio, etc), cloud solutions (AWS, Azure), and/or functional capabilities specific to business function such as QMS , LMS, RIM (Submissions, Registrations and Publishing) systems widely used in pharma]
Experience with regulatory frameworks and compliance in a GxP environment
Exceptional leadership and team-building skills, with the ability to inspire and motivate diverse teams
Strong strategic thinking and problem-solving abilities, with a data-driven approach to decision-making
Excellent communication, presentation, and interpersonal skills, with the ability to influence and collaborate effectively at all levels of the organization
Deep understanding of product management methodologies (e.g., Agile, Scrum, Kanban) and product lifecycle management
Solid technical acumen with the ability to understand complex IT architectures and development processes
Strong background in platforms such as Veeva Quality, Veeva RIM, ComplianceWire and Cloud Computing
Ability to manage multiple priorities in a fast-paced, dynamic environment
Benefits
401k plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Sales-based incentive plan
Opportunity to purchase company stock
Receive long-term incentives
15 accrued vacation days in their first year
17 paid holidays including a company-wide winter shutdown in December
Up to 10 sick days throughout the calendar year
Company
Exelixis
Exelixis works is focused on discovering, developing and commercializing therapies for the treatment of cancer and other serious diseases.
1001-5000 employees
H1B Sponsorship
Exelixis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (39)
2024 (25)
2023 (25)
2022 (28)
2021 (29)
2020 (15)
Funding
Current Stage
Public CompanyTotal Funding
$514MKey Investors
Deerfield
2015-07-23Post Ipo Equity· $135M
2012-02-16Post Ipo Equity· $65M
2010-06-03Post Ipo Debt· $160M
Leadership Team
Michael Morrissey
President and CEO
Christopher Senner
Executive Vice President and CFO
Recent News
GlobeNewswire
2026-01-23
2026-01-18
2026-01-12
Company data provided by crunchbase