Associate Director, GMA Evidence Generation Operations Rare Genetics and Hematology

Company: Takeda Pharmaceutical
Location: Newark
Posted on: November 19, 2021

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 Takeda's and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAssociate Director, GMA Evidence Generation Operations -Rare Genetics and HematologyAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Associate Director, GMA Evidence Generation Operations, Rare Genetics and Hematology. 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.As Associate Director, GMA Evidence Generation Operations working on the Evidence Generation team, you will oversee and manage the activities of Global Medical Evidence Operations managers, including the initiation, tracking, completion, and reporting of studies.- A typical day will include:POSITION OBJECTIVES:

• Manage all aspects of assigned program including Medical Affairs Company Sponsored Studies (MACS), Investigator Initiated Research (IIR), and Externally Sponsored Collaborative Clinical Research (CCR) studies for assigned therapeutic areas and product programs.
• Manage TA and product level study budgets. Manages all finance related aspects for global studies - invoicing, accruals and forecasting.
• Responsible for the conduct of studies in accordance with all applicable internal legal and compliance policies (SOPs) as well as external regional and country specific regulatory guidelines.
• May serve as the therapeutic operational area lead for interfacing with internal stakeholders (e.g. GMA, Region and LOC medical leads, TA Medical Heads, alliance partners, etc.) and external investigators to develop and track research plans and budgets. -
• Support training of managers and regions/LOCs on MACS, Collaborative Research and IIRs.POSITION ACCOUNTABILITIES:
  • Facilitate receipt, processing, and internal cross-functional review of internal/external study submissions-
  • Review research committee materials including study concepts and protocols, meeting minutes, and investigator communications for completeness, alignment to strategy and Takeda`s policies, as applicable.
  • Lead required cross-functional review meetings to review, approve, and track studies and ensure proper documentation and archiving (minutes, team communications, etc.) of review outcomes.
  • Coordinate the capture, archiving and reporting of appropriate study level information (including patient safety information) and deliverables. Communicate study activities to internal stakeholders.
  • Management of the internal iEnvision (or equivalent system) and document repositories per Medical Affairs SOPs and processes.
  • Coordinate with Pharmacovigilance and Quality to respond to external audits, CAPAs and requests from external regulatory bodies.
  • Perform vendor management, including contract co-ordination
  • Contribute to pre- fair market value (FMV) evaluation of proposed study budget and oversee the conduct of FMV assessments of budgets submitted for approved studies in accordance with Takeda policies and procedures.
  • Support Evidence Generation subteam, providing support for team set-up, meeting agenda and minutes and driving evidence generation activities
  • Lead process improvement initiatives and contributes to the development and updates of SOP, Job Aids and system upgrades
  • Provide leadership and guidance to other Operations leadsEDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
    • Minimum MS degree required (preferably PhD), preferably in a health sciences related field with 6 years of research related experience and/or pharmaceutical industry experience.
    • Experience with late stage clinical studies, research collaborations and RWE
    • Proven track record of strong leadership, project management and demonstrated ability to coach and mentor individuals.
    • Ability to communicate and interact thoughtfully, transparently, and appropriately with a variety of stakeholders both internal and external to Takeda.Takeda U.S. Vaccine Requirement:Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.This job posting exclude Colorado applicants.WHAT 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 ProgramsEmpowering Our People to ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters Please.*RM-LIEEO 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.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

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