Foster City

POSITION SUMMARY

 We are seeking a visionary and strategic IT leader to oversee and scale global business applications in support of a rapidly growing, multinational commercial rare disease company. This role is responsible for developing and executing an enterprise-wide IT roadmap, leading cross-functional strategy initiatives, and ensuring all systems meet GxP and SOX compliance standards. The ideal candidate will have deep expertise in pharmaceutical industry applications, proficiency in ERP platforms like NetSuite, SAP, or Oracle, and a proven ability to drive innovation, including AI integration. This position requires exceptional communication skills, experience managing diverse teams and vendors, and the ability to operate effectively in a high-growth, fast-paced environment. The role will serve as a key partner to executive leadership, driving technology strategies that support business expansion, enhance patient services, and ensure regulatory readiness.

JOB FUNCTIONS/RESPONSIBILITIES

• Create, seek buy-in and implement an enterprise-wide business applications roadmap that supports the rapidly expanding business.
• Create and lead a cross-functional IT strategy steering committee
• Build and expand team to meet the need of the rapidly expanding business
• Scale IT operations to ex-US countries and provide technical support remotely
• Point of contact for Information Technology during regulatory audits
• Provide leadership in system delivery/implementation, ensuring GxP and SOX compliance are monitored on all key systems.
• Collaborate with executive leadership team to understand current and future needs.
• Assess innovative technologies and vendors through pilots and site visits.
• Incorporate AI into the work of functional groups and maintain appropriate SOPs to govern its use.
• Participate in portfolio and budget planning.
• Develop the strategy for system level risk assessments, IT change controls, periodic reviews, and user account reviews for systems in portfolio.
• Oversee business application elements of SOX compliance including coordination with internal/external auditors on quarterly and annual reviews.
• Participate in innovative technology vendor discussions to ensure adherence to corporate standards.
• Manage team of IT resources and predict resource requirements across the year, which includes engineer, support staff, analysts, and senior executives.
• Strategize with Commercial Team on how to build a cohesive data strategy and patient support services.
• Invest in personal development of self and team members to ensure the department stays on cutting edge of IT trends and leverage opportunities to improve the functioning of Mirum.
• Ensure all IT systems are SOX compliant.

 QUALIFICATIONS

• Proven leader with experience setting and executing IT strategy for a fast-growth multinational commercial rare disease company.
• Intimately familiar with pharmaceutical industry applications and processes.
• Proficient in mid-tier ERP application NetSuite, SAP, or Oracle.
• Must communicate exceptionally well, both in writing and verbally, including communicating with dispersed/remote teams.
• Able to execute well and within tight timelines and within reasonable budgets.
• Provides technology expertise and guidance for team members.
• Understanding of current technology and processes, such as AI and Cybersecurity.
• Builds relationships and partnerships with key internal and external stakeholders
• Must be able to understand and mediate needs of multiple stakeholders, who may have competing priorities.
• Proven ability working in a high growth environment and leading multi-level / cross functional teams including coordinating vendors and third-party resources, as necessary.
• Consistently demonstrates core values of confidentiality, transparency, and trust.
• Ability to manage a team of internal stakeholder and external vendors.

Education/Experience:

• MS degree from an accredited, four-year college or university preferably in information systems; advanced degree preferred.
• 10+ years of relevant work experience in biotech/pharmaceuticals with increasing levels of responsibility, with at least 8 years working on business transformation and/or IT implementation/management.

Knowledge, Skills, and Abilities:

• Direct knowledge of procedures/ best practices related to FDA Regulations, SOX, EU GMP Annex 11, 21 CFR Part 11, CSV, GAMP 5, GxP, HIPAA.
• Knowledge of regulatory validation requirements including FDA, EMA, and all other Worldwide Regulatory requirements (ICH Q9 and Q10) particularly as it applies to regulated software development.
• Must be familiar with Order-to-Cash, Supply Chain processes operating in a global environment as it relates to ERP systems.
• Familiar with System Development Lifecycle (SDLC) in a regulated environment.
• Ability to articulate technical problems and business value to a wide business audience.
• Experience with a centralized data warehouse and can articulate the infrastructure and analytics deliverables

Location:

• The position is in-house located at our corporate headquarters in Foster City, CA
• Some travel to other Mirum locations, including Switzerland is required

The salary range for this position is $290,000 to $305,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided. 

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