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Principal Clinical Outcomes Scientist

Plats Waltham, Massachusetts, USA Jobb-id R-090671 Datum inlagd 09/17/2020

Clinical Outcomes Assessment - Principal Clinical Outcomes Scientist - Digital Health Measurement Science- Digital Health R&D Oncology

We’re building out a best in class Measurement Science team to support the R&D portfolio as well as digital therapeutics, which will be part of the future of measurement science and analytics to support novel endpoints.

Digital health, the point at which healthcare, technology, data and analytics converge, is the subject of great promise, with the World Health Organisation believing it has the potential to improve health for everyone. At AstraZeneca, we’ve been working hard to make this a reality, with the years of experience we have accumulated enabling us to now embed digital health at scale across R&D. To achieve our goal of improving patient experience and outcomes AstraZeneca has Digital Health as one of the top 4 strategic priorities for the company, details on digital health strategy can be found here. Oncology is the largest therapeutic area within AstraZeneca and second highest cause of death globally, with AstraZeneca’s ambition to eliminate cancer as a cause of death.

An Outcomes Scientist in the Digital Health Measurement Science group will serve as a subject matter expert regarding the use of clinical outcomes assessments (COA) such as traditional survey-like instruments using rating or ranking scales and novel sensor/wearable data capture instruments to inform identification and/or evaluation of symptoms, function, health-related quality of life, or other patient-centric concept of clinical benefit throughout the oncology drug development lifecycle.  With supervision, the Scientist will be responsible for providing quantitative measurement expertise for the development and execution of patient-centered measurement strategy and dissemination of its findings to key stakeholders, such as R&D global and/or cross-functional teams, regulators, payers, healthcare professionals and most importantly patients in support of more efficient identification of treatment benefits vs harms in Oncology.  This includes but is not limited to: identification of unmet measurement need, description of context of use (e.g., selection of responders for fit-for-purpose use of Patient-Reported Outcomes, Observer-Reported Outcomes, Clinician-Reported Outcomes, or Performance Outcome assessments), definition of data collection strategy and implementation in clinical research or real world setting, collaboration for data analyses and interpretation and audience-adapted publications.

What you’ll do

As the Outcomes Scientist, you will play a pivotal role  in channelling our scientific capabilities to make a positive impact on changing patients’ lives through the following:

  • Contribute to qualitative and quantitative research to generate evidence of patients' experience with treatment throughout the oncology drug development lifecycle (e.g., identification of unmet measurement need, endpoints capturing symptoms, function, or quality of life evolution overtime to inform disease progression or tolerability)
  • Responsible for project management of functional service provider(s) for qualitative and quantitative research to inform development of conceptual disease-models and related endpoints to address measurement gap to inform the patients' experience with treatment.
  • With supervision, contribute to the development or selection and interpretation of COA in clinical research to inform clinical benefit evaluation of oncology treatment, including: measurement performance evaluation of symptom(s), function and health-related quality of life instruments,  definition or development of novel COA endpoints to address evidence needs from key stakeholders,  and  inclusion of COA endpoints and findings in all major deliverables such as: clinical development plans, study protocols, and strategic and operational reports.
  • Collaborate and partner with key internal stakeholder colleagues to ensure priorities and strategies are aligned.
  • Prepare, review, and publish scientific reports, internal/ conference presentations, publications, regulatory dossiers reflecting ongoing or completed work, with supervision.

Essential for the role

  • Combination of academic training and practical experience in outcomes research. This may consist of:
    • Minimum a Doctoral degree (e.g., Ph.D., Sc.D. or D.Ph.) in a relevant discipline such as, but not limited to, health services research, health outcomes research, epidemiology, pharmacy administration, public health, economics, statistics or decision sciences, plus two years practical experience
    • Clinical degree (e.g., in medicine, pharmacy, nursing) and a masters degree in a related discipline (as noted above), plus two years practical experience
    • Masters degree in a related discipline (as noted above), plus five years practical experience
  • Experience in performing outcomes research, in any setting, including life sciences company, research organization, academic institution or governmental agency including experience in interpreting COA data from clinical research and communicating scientific evidence.
  • Working knowledge of Patient Focused Drug Development (PFDD) FDA Guidance documents and other relevant guidance documents and best practices to capture patient's experience in drug lifecycle
  • Conceptual, analytical and strategic thinking
  • Creative, innovative, solution-focused
  • Curious, embraces new ways of problem solving, new ideas, new ways of working
  • Strong communication skills and ability to build relationships

Desirable for the role

  • Conducting of outcomes research studies, and the communication of study findings to internal and external audiences
  • Experience with the development, psychometric evaluation and selection of PRO instruments used in clinical studies
  • Experience in conducting outcomes research in different geographic regions and interacting with regulator and policy-makers
  • Diligence - attention to detail and ability to manage a program of concurrent activities
  • Resilience - ability to overcome and motivate others in the face of a changing environment

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

So, what’s next!

  • Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.

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Where can I find out more?

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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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