Head, GCP Process and Operational Excellence
Company: Takeda Pharmaceuticals
Location: Cambridge
Posted on: January 21, 2023
Job Description:
By clicking the Apply button, I understand that my employment
application process with Takeda will commence and that the
information I provide in my application will be processed in line
with Takedas Privacy Notice and Terms of Use . I further attest
that all information I submit in my employment application is true
to the best of my knowledge.Job DescriptionAre you looking for a
patient-focused, innovation-driven company that will inspire you
and empower you to shine? Join us as Head, GCP Process and
Operational Excellence in our Cambridge, MA office.At Takeda, we
are transforming the pharmaceutical industry through our
R&D-driven market leadership and being a values-led company. To
do this, we empower our people to realize their potential through
life-changing work. Certified as a Global Top Employer, we offer
stimulating careers, encourage innovation, and strive for
excellence in everything we do. We foster an inclusive,
collaborative workplace, in which our global teams are united by an
unwavering commitment to deliver Better Health and a Brighter
Future to people around the world.Here, you will be a vital
contributor to our inspiring, bold mission.OBJECTIVES/PURPOSE:As
the Head, GCP Process and Operational Excellence, reporting to the
Global Program Lead, Alta Petens, you will lead the Data Sciences
Institute (DSI) GCP Process and Operational Excellence team, which
partners with Statistical and Quantitative Sciences, Clinical Data
Sciences, Global Evidence and Outcomes, Quantitative Clinical
Pharmacology, R&D Information Technology, and Digital Health
Sciences to ensure inspection-ready delivery of clinical programs
in compliance with internal process and external regulations. You
will support strategy and delivery of global clinical programs as
defined in the Clinical Development Plan (CDP) by guiding high
operational data quality, inspection readiness, compliance to HCP
engagement regulations, and TMF management activities. You will
work closely with the functional lines within Takeda's Data Science
Institute (DSI) to develop and refine Takeda's clinical data
collection, reporting, digital technology and development SOPs and
ensure training compliance across the Data Science Institute. You
will partner with Quality Assurance and the Global Development
Office to develop training tools and ensure compliant trial
execution and timely clinical trial delivery.ACCOUNTABILITIES:GCP
Process & Compliance:
- Oversee the implementation of processes, SOPs, tools, training
curriculum, and programs to enhance clinical trial delivery,
focusing on functions within the Data Science Institute.
- Partner with Quality Assurance team regarding deviations,
Quality Investigations, CAPAs, and related events
- Manage learning plans for internal staff in QMS, create
training relating to updates in Takeda's clinical development
operating model as it relates to the delivery of DSI functional
areas
- Drive process improvement, compliance and integration of new
assets/companies across Data Science InstituteClinical Document
Management:
- Provide strategic input into the development of Trial Master
File (TMF) strategy and plans
- Be a subject matter expert on the management of TMF, maintain
knowledge of the TMF Reference Model, industry best practices, and
regulatory considerations
- Ensure Takeda's electronic TMF platform meets our needs
- Support existing eTMF platform from a business perspective, as
capabilities expand within the platformInspection Strategy,
Readiness & Execution:Oversee execution of all activities related
to Inspection Readiness, including:
- Create oversight framework for outsourced studies
- Provide Inspection Readiness and Strategy support to teams
before anticipated inspections (BIMO, pre-approval, GCP
inspections); activities include storyboarding support, partnering
with QA before and during inspections, and supporting team
preparation pre-inspection and team responses
post-inspectionClinical Data Technology and Reporting
- Lead a team in ensuring clinical program-wide compliance with
reporting and disclosure regulations (including Sunshine Act
reporting and tax reporting) by maintaining technology to analyze
and report relevant clinical trial data metrics
- Ensure clinical data integrity to allow for clinical trial
acceleration
- Represent the business in data governance forums where clinical
data is in scope
- Partner with representatives from the Data Sciences Institute;
provide strategic guidance on operational data standards to support
system implementation and inter-operability and automationTrial
Delivery Training Development and Implementation:
- Partner with teams and functional leaders to define the future
operating model as it relates to clinical trial delivery; ensure
availability of tools, reference documents, and training content
(e.g., RACIs, document templates, and interactive process
maps)
- Manage technology platform to ensure interactive training
modules, role-specific training, and other resources to promote
accelerated trial executionEDUCATION, BEHAVIOURAL COMPETENCIES AND
SKILLS:
- Bachelor's Degree or international equivalent required, Life
Sciences preferred
- 10+ years experience in the pharmaceutical industry and/or
clinical research organization
- 6+ years in clinical study management
- 6 years of line management experienceWHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution
Plan
- Tuition reimbursement Company match of charitable
contributions
- Health & Wellness programs including onsite flu shots and
health screenings
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach ProgramsDiscover more at takedajobs.comNo
Phone Calls or Recruiters Please.#LI-KD1This position is currently
classified as hybrid in accordance with Takedas Hybrid and Remote
Work policy.Base Salary Range: $194,600.00 to $278,000.00.
Employees may also be eligible for Short Term and Long-Term
Incentive benefits. Employees are eligible to participate in
Medical, Dental, Vision, Life Insurance, 401(k), Charitable
Contribution Match, Holidays, Personal Days & Vacation, Tuition
Reimbursement Program and Paid Volunteer Time Off.The final salary
offered for this position may take into account a number of factors
including, but not limited to, location, skills, education, and
experience.EEO StatementTakeda is proud in its commitment to
creating a diverse workforce and providing equal employment
opportunities to all employees and applicants for employment
without regard to race, color, religion, sex, sexual orientation,
gender identity, gender expression, parental status, national
origin, age, disability, citizenship status, genetic information or
characteristics, marital status, status as a Vietnam era veteran,
special disabled veteran, or other protected veteran in accordance
with applicable federal, state and local laws, and any other
characteristic protected by law.LocationsCambridge, MAWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceuticals, Cambridge , Head, GCP Process and Operational Excellence, Other , Cambridge, Massachusetts
Didn't find what you're looking for? Search again!
Loading more jobs...