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Associate Director OR Director  Evidence & Value Generation London United Kingdom,  

Takeda (company)

Posted on : 26 January 2017

Project Description

  • This position functions within company s Global Medical Affairs organisation and reports into the Head of Evidence Generation  Specialty GI. 
  • As a member of the Evidence and Value Generation team, the candidate will engage in research studies that identify clinical, economic, and patient-centric unmet needs in addition to value that company s medicines provide in addressing these needs. 

Key objectives are:
  • To provide support and  consultative expertise primarily at peri-launch, launch and  commercialization stages across the product life cycle
  • To contribute to the   development and execution of plans to elucidate unmet clinical, economic   and patient-centered needs and product value
  • To design, execute and  communicate results of appropriate tactical activities supporting those   plans
  • To collaborate and align  internally with other company  teams within a matrix organisation to meet   product needs 
  • To communicate findings from these evidence generation activities to relevant internal and external audiences as effectively as possible.
  • Work within a   multidisciplinary, matrix organisation to develop and execute successful  outcomes and epidemiology research strategies for the GI Specialty      therapeutic area
  • Design, implement and  communicate results of real-world, health outcomes and epidemiology  research studies that help achieve product-specific objectives.
  • Represent the function on  cross-functional teams related to product development and  commercialisation.  
  • Collaborate and partner with  key internal stakeholder colleagues to ensure priorities and strategies  are aligned  
  • Perform relevant research   activities which may include, but are not limited to:
  • Targeted or comprehensive   systematic literature reviews
  • Design, execution, and  analysis of longitudinal prospective observational or randomized clinical  trials evaluating clinical, patient-centered, and/or economic endpoints
  • Longitudinal retrospective  studies of existing databases
  • Retrospective or prospective   evaluations of disease natural history and treatment patterns, including  drug utilization and adherence
  • Cross-sectional surveys of   patients, caregivers, health care providers/practitioners, and/or   payers/health technology assessment authorities   
  • Clinical-economic models and   assessments exploring burden of illness and/or comparative effectiveness
  • Have good knowledge of PRO and  HRQoL instruments and interpretation of data  collected through these tools to   articulate value of therapy
  • Prepare and/or review  research protocols, statistical analysis      plans (SAPs),and reports
  • Prepare, review, and publish   scientific reports reflecting ongoing or completed work
  • Communicate findings to  relevant internal and external audiences, which may include regulators,  health care providers/practitioners, HTA authorities/payers, patients and   others
  • Ensure findings are   communicated effectively, and as appropriate in conference presentations,  publications, and submission dossiers.

  • Experience in outcomes and  observational research and/or pharmacoepidemiology in specialty care  pharmaceuticals
  • Demonstrated experience in  designing and conducting  observational  studies focusing on IBD or immune mediated disorders is highly desirable
  • Combination of academic  training and practical experience in outcomes research, epidemiology,  pharmacoepidemiology, or real world evidence generation is required.   This may consist of:
  • Doctoral degree in a relevant discipline such as, but not limited to, health services research, health   outcomes research, epidemiology, public health, economics, statistics or    decision sciences, plus practical experience
  • Clinical degree (e.g., in   medicine, pharmacy, nursing) and a masters degree in a related discipline (as noted above), plus practical experience
  • Masters degree in a related    discipline (as noted above), plus extensive practical experience.         
  • Practical experience in performing observational research, in any setting, including   life-sciences company, research organisation, academic institution or      governmental agency, is required. 
  • Experience should include   communication of study findings to internal and external audiences.
  • Familiarity with the role and importance of real world evidence, epidemiology, observational, and outcomes  research in the multi-disciplinary drug development and commercialization  environment and process is expected.
  • Demonstrated expertise in at least one research area (such as, but not limited to, retrospective or  prospective observational studies, patient-reported      outcomes/health-related quality of life assessment, clinical-economic modelling and analysis, literature synthesis/meta-analysis) is highly  desirable. 
  • Knowledge of health economics   is desirable.
  • Demonstrated experience in conducting or interpreting statistical analysis.
  • Experience in conducting  research in different geographic regions is desirable.
  • Ability to work collaboratively  and effectively in a multicultural and cross-functional team environment  is expected.
  • Broad experience in collaborating with contract research organisations and research partners in managing  multiple tasks and complex projects is very desirable.
  • Ability to communicate  scientific evidence, with strong written and verbal presentation skills, is required.
  • Record of high-quality,  peer-reviewed publications is preferred.



London England United Kingdom

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