Senior Director, IT Business Partner

Akebia Therapeutics•Cambridge, MA

1d•$244,102 - $301,538•Hybrid

About The Position

Akebia Therapeutics is looking for an IT leader to partner with Research and Development Quality, CMC and Supply Chain functions to plan, implement, integrate, and support mission- critical applications and business processes in a GxP regulated environment. This role advocates for and is a liaison with leaders and stakeholders in R&D (Research, Pre-Clinical, Clinical development), CMC, Quality, Supply Chain and laboratory operations. This role will collaborate and consult with stakeholders/client groups on a regular basis to ensure that IT is aware of the functions’ strategy and goals in order to identify new or enhanced capabilities and plan relevant investments in technology solutions and services. This role will ensure that stakeholders are consulted about changes to IT processes and services, and that specific requirements are taken into account when new or changes to IT services/underlying infrastructure are being planned. The role will also ensure that interoperability, architectural and security standards, and responsiveness levels are defined according to both IT and stakeholder group requirements This individual will have a proven track record of working collaboratively and cross-functionally with multiple functions to establish and manage a technology solution roadmap and lead a project portfolio to implement and support diverse business needs. The ideal candidate will have solid business acumen, be comfortable as a change agent, and have a background in implementing and supporting the latest cloud-based applications to achieve important business objectives in a dynamic environment.

Requirements

Bachelor’s Degree
10+ years experience in technology leadership roles
15+ years experience in business partnerships/system implementation/application support
10-15 years experience in a public, commercial-stage company in the pharmaceutical or biotech industry
15+ years experience in science-related technology roles
Extensive experience with GxP applications including Veeva R&D Vaults (Quality Docs, QMS, RIM, MedComms/Medical Inquiry) or equivalent systems
Proven track record of administering GxP systems and thinking holistically about the business processes critical to company success across multiple systems and departments
Experience effectively managing vendors to achieve business goals while maintaining project timelines and budget
Experience project managing application, integration, and reporting projects throughout the entire project lifecycle including requirements gathering and documentation, vendor selection, implementation tracking, risk/issue management, change management as well as system documentation, release, and training
Experience as a business analyst, including identification of non-technical business requirements, translating specifications into solution designs, ensuring quality and successful testing, financial and resource management
Exceptional knowledge of 21 CFR Part 11 compliance and Computer System Validation (CSV)
Ability to multi-task and meet deadlines in a fast-paced, changing environment. Self- starter, hands-on attitude and out of the box thinking.
Proven analytical thinking and problem-solving capability
Experience with other R&D functions and systems including but not limited to Safety Databases and reporting, analytics and dashboards.

Responsibilities

Proactively engage and partner with function leaders and their teams to develop and evolve a rolling 24‑month application strategy and roadmap tied to company milestones and budget.
Collaborate with departmental management, IT partners, outside vendors, and internal stakeholders to plan, implement, integrate, administer, and support applications for Regulatory, Safety/Pharmacovigilance, CMC, Quality, and Medical Affairs functions
Lead demand intake, evaluation and implementation governance for your client portfolios; convert requests into value‑scoped initiatives and sequence them within and enterprise roadmap.
Work with VP, IT to manage multiple concurrent and potentially interconnected timelines, prioritizing deliverables, and keeping key stakeholders involved and informed of changes and consequences
Define process & data architecture to eliminate silos and embed GxP by design.
Drive vendor & license management (e.g. negotiate renewals) and change enablement for adoption and value.
Become the subject matter expert for the applications and processes in your portfolio and act as a solutions analyst to your constituent partners
Contribute to the yearly budgeting for the constituent groups and verify that the company is maximizing its investments in systems and business processes
Develop and maintain processes and procedures relevant to the validation of systems as well as maintaining the validated state of systems
Communicate project schedules, budgets, deliverables, risks, and issues to your portfolio stakeholders and align timelines with other corporate objectives
Lead cross-functional teams to manage master data, integration, and reporting projects
Lead implementations and support technology of solutions and services to support the company’s digital strategy
Own the relationship with internal and external managed services vendors to ensure full end-to-end support for applications, data integrations, and processes in supported functions
Stay current with industry technology best practices and proactively look to disrupt inefficient systems and processes for the advancement of the company