Senior Director, IT Business Partner

IT

This position is currently based in our Cambridge, MA office. Please note that our offices will be relocating to Waltham, MA later this year, and this role will transition accordingly. We follow a flexible, "magnet not mandate" approach to in-office work, encouraging collaboration and onsite engagement while supporting hybrid flexibility based on role and business needs.

Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million.

At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them.
Our tenacious, passionate employees' challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease.

This is life-changing work, and we are all in, are you?

Job Summary:

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.

Essential Functions & 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

Basic Qualifications:

* 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

Skills & Experience:

* 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.

Compensation:

Targeted Base: *$244,102-$301,538

*Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company's total rewards package, all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.

Are you an Akebian?

An Akebian is curious, empathetic, and values making connections to people and ideas. Akebian's aren't afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebian's believe that we are better together because we are all working toward a common purpose - to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website: www.akebia.com

Akebia is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.