Senior Director, IT Business Partner
Akebia Therapeutics
1 month ago
Remote friendly (Cambridge, MA)
United States
IT
Job Summary
- IT leader partnering with Research and Development Quality, CMC, and Supply Chain to plan, implement, integrate, and support mission-critical applications and business processes in a GxP regulated environment.
- Liaison with stakeholders across R&D, CMC, Quality, Supply Chain, and laboratory operations.
- Collaborate regularly with stakeholders to align IT with functions’ strategy/goals, identify capabilities, and plan technology investments.
- Ensure stakeholder input on IT process/service changes and requirements for new/changed IT services and underlying infrastructure, including interoperability, architectural/security standards, and responsiveness.
Essential Functions & Responsibilities
- Develop and evolve a rolling 24-month application strategy/roadmap tied to milestones and budget.
- Plan, implement, integrate, administer, and support applications for Regulatory, Safety/Pharmacovigilance, CMC, Quality, and Medical Affairs.
- Lead demand intake, evaluation, and implementation governance; scope and sequence initiatives within the enterprise roadmap.
- Manage multiple concurrent/interconnected timelines and prioritize deliverables with stakeholder communication.
- Define process and data architecture to eliminate silos and embed GxP by design.
- Drive vendor and license management and change enablement for adoption/value.
- Serve as subject matter expert and solutions analyst for the applications/processes in the portfolio.
- Contribute to yearly budgeting and verify maximized investment in systems and business processes.
- Develop/maintain system validation-related processes and maintain validated state.
- Communicate schedules, budgets, deliverables, risks/issues; align with corporate objectives.
- Lead cross-functional teams on master data, integration, and reporting projects.
- Lead implementations and support for solutions/services aligned to digital strategy.
- Own relationships with managed services vendors to ensure end-to-end support for applications, data integrations, and processes.
- Stay current with technology best practices and improve/disrupt inefficient systems/processes.
Basic Qualifications
- Bachelor’s Degree
- 10+ years in technology leadership roles
- 15+ years in business partnerships/system implementation/application support
- 10–15 years in a public, commercial-stage pharmaceutical/biotech company
- 15+ years in science-related technology roles
Skills & Experience (Required/Preferred)
- Extensive GxP application experience (e.g., Veeva R&D Vaults: Quality Docs, QMS, RIM, MedComms/Medical Inquiry) or equivalent
- Proven administration of GxP systems and holistic understanding of critical business processes across departments
- Vendor management experience maintaining timelines and budget
- End-to-end project management of application/integration/reporting lifecycle (requirements, documentation, vendor selection, tracking, risk/issue, change management, release, training)
- Business analyst experience translating non-technical requirements into solution designs; testing quality; financial/resource management
- Exceptional knowledge of 21 CFR Part 11 and Computer System Validation (CSV)
- Ability to multitask, meet deadlines, self-starter hands-on approach; strong analytical/problem-solving
- Experience with other R&D functions/systems (e.g., safety databases/reporting; analytics/dashboards)
Compensation (if applicable)
- Targeted base: $244,102–$301,538; eligibility for bonus/incentives and equity; additional benefits include health care, vision, dental, retirement, PTO.
- IT leader partnering with Research and Development Quality, CMC, and Supply Chain to plan, implement, integrate, and support mission-critical applications and business processes in a GxP regulated environment.
- Liaison with stakeholders across R&D, CMC, Quality, Supply Chain, and laboratory operations.
- Collaborate regularly with stakeholders to align IT with functions’ strategy/goals, identify capabilities, and plan technology investments.
- Ensure stakeholder input on IT process/service changes and requirements for new/changed IT services and underlying infrastructure, including interoperability, architectural/security standards, and responsiveness.
Essential Functions & Responsibilities
- Develop and evolve a rolling 24-month application strategy/roadmap tied to milestones and budget.
- Plan, implement, integrate, administer, and support applications for Regulatory, Safety/Pharmacovigilance, CMC, Quality, and Medical Affairs.
- Lead demand intake, evaluation, and implementation governance; scope and sequence initiatives within the enterprise roadmap.
- Manage multiple concurrent/interconnected timelines and prioritize deliverables with stakeholder communication.
- Define process and data architecture to eliminate silos and embed GxP by design.
- Drive vendor and license management and change enablement for adoption/value.
- Serve as subject matter expert and solutions analyst for the applications/processes in the portfolio.
- Contribute to yearly budgeting and verify maximized investment in systems and business processes.
- Develop/maintain system validation-related processes and maintain validated state.
- Communicate schedules, budgets, deliverables, risks/issues; align with corporate objectives.
- Lead cross-functional teams on master data, integration, and reporting projects.
- Lead implementations and support for solutions/services aligned to digital strategy.
- Own relationships with managed services vendors to ensure end-to-end support for applications, data integrations, and processes.
- Stay current with technology best practices and improve/disrupt inefficient systems/processes.
Basic Qualifications
- Bachelor’s Degree
- 10+ years in technology leadership roles
- 15+ years in business partnerships/system implementation/application support
- 10–15 years in a public, commercial-stage pharmaceutical/biotech company
- 15+ years in science-related technology roles
Skills & Experience (Required/Preferred)
- Extensive GxP application experience (e.g., Veeva R&D Vaults: Quality Docs, QMS, RIM, MedComms/Medical Inquiry) or equivalent
- Proven administration of GxP systems and holistic understanding of critical business processes across departments
- Vendor management experience maintaining timelines and budget
- End-to-end project management of application/integration/reporting lifecycle (requirements, documentation, vendor selection, tracking, risk/issue, change management, release, training)
- Business analyst experience translating non-technical requirements into solution designs; testing quality; financial/resource management
- Exceptional knowledge of 21 CFR Part 11 and Computer System Validation (CSV)
- Ability to multitask, meet deadlines, self-starter hands-on approach; strong analytical/problem-solving
- Experience with other R&D functions/systems (e.g., safety databases/reporting; analytics/dashboards)
Compensation (if applicable)
- Targeted base: $244,102–$301,538; eligibility for bonus/incentives and equity; additional benefits include health care, vision, dental, retirement, PTO.