Senior Director, IT Business Partner
DiversityJobs, Cambridge, MA, United States
Senior Director, IT Business Partner
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IT
Cambridge, MA *
ID:
26A-13
* Full-Time/Regular
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 (R
esearch, 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.
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IT
Cambridge, MA *
ID:
26A-13
* Full-Time/Regular
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 (R
esearch, 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.