Posted to MedZilla on 8/18/2017


Takeda Pharmaceuticals

US-MA, Associate Director, Clinical Operations (GMA) 1700397-MZ


 
 

More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, central nervous system and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.
While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients lives. If you are driven to create better health and a brighter future, join us!

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


  • 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%



we are driven to improve people's lives

www.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, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.

*LI-CB1


Schedule


Please visit our website at takedajobs.com

 
 


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