Associate Director, Clinical Operations (GMA)
Location:
Cambridge , Massachusetts
Posted:
December 12, 2017
Reference:
1700397


Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Associate Director, Clinical Operations (GMA) in our Cambridge, Massachusetts office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Associate Director, Clinical Operations (GMA) working on the Global Medical Affairs Research team, you will be empowered to make meaningful contributions, and a typical day will include:



OBJECTIVES:

  • Planning and execution of phase 4 Global Medical Affairs studies across the oncology portfolio
  • Direct oversight of strategic partners, including CROs and other vendors, to ensure study plans, timelines, and budgets meet are aligned with research objectives and standards
  • Manage study operations staff and lead cross-functional study teams
  • This position will report to the Head of GMA Research


ACCOUNTABILITIES:
  • Lead the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors related to clinical trial conduct, including budget and contract negotiation and supervision of vendor activities
  • Develop study management plans that include enrollment milestones, risk mitigation, financial oversight, and communication and monitoring plans
  • Contribute to the development of study protocols to ensure operational feasibility and success in meeting study objectives
  • Collaborate with Medical Directors to identify study investigator and sites; facilitate sponsor-site relationships
  • Ensure execution of study progress according to timelines and goals
  • Plan and lead, in collaboration with Medical personnel, internal review meetings to communicate study progress, identify and provide solutions to clinical trial issues and risk, and to ensure timely decision making by the team
  • Prepare study progress reports for senior leadership
  • Liaise with Clinical Supply to provide drug supply forecasts
  • Work with Medical Directors and study team to develop data communication plan
  • Lead planning and execution of Investigator, Steering Committee, and vendor meetings
  • Develop best practices and SOPs, as necessary, to be applied to phase 4 study program
  • Attend medical conferences, as needed








Qualifications:

  • EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Bachelor’s or advanced degree in a scientific or healthcare discipline preferred
  • 8+ years clinical development experience in the biotech/pharmaceutical industry
  • Experience in managing both interventional and observational studies preferred
  • Thorough understanding of FDA, EMEA, ICH and GCP guidelines, as well as a thorough understanding of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, regulatory affairs, and legal affairs
  • Extensive experience in managing clinical programs, CROs, budgets and timelines
  • Protocol, ICF, and CSR writing experience required
  • Strong working knowledge of MS Project or other project management software
  • Ability to function at a high level when leading a group or managing clinical research staff
  • Ability to manage multiple priorities
  • Experience in both interventional and observational studies preferred
  • Experience in oncology preferred


TRAVEL REQUIREMENTS:
  • Up to 10%


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 Programs



Empowering Our People to Shine

Learn more at takedajobs.com .

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.



*LI-CB1




A little about us:
Takeda fosters an inclusive environment where all employees are empowered to shine.

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