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