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Director, Measurement Science, DH R&D

Plats Waltham, Massachusetts, USA Jobb-id R-087136 Datum inlagd 07/20/2020

Job Description : Senior Outcomes Scientist - Digital Health Measurement Science- Digital Health R&D Oncology

Digital health, the point at which healthcare, technology, data and analytics converge, is the subject of phenomenal promise, with the World Health Organization 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 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.

The Senior Outcomes Assessment Scientist, will serve as a subject matter authority 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 advise identification and/or evaluation of symptoms, function, health-related quality of life, or other patient-centric concept of clinical benefit in the oncology drug development lifecycle. 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 partners, such as R&D global and/or cross-functional teams, regulators, payers, healthcare professionals and most meaningfully, 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, teamwork for data analyses and interpretation and audience-adapted publications. The Scientist should be published as a professional within own area of specialization.

Typical Accountabilities

  • Serves as a subject matter authority in applying 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 interpret disease progression or tolerability)
  • Designs, conducts and interprets and/or supervises functional service provider(s) for qualitative and quantitative research to advise in development of conceptual disease-models and related endpoints to address measurement gap to inform the patients’ experience with treatment.
  • Develops or selects then implements and interprets COA in clinical research to advise 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 partners, and inclusion of COA endpoints and findings in all major results such as: clinical development plans, study protocols, and strategic and operational reports.
  • Prepare, review, and publish scientific reports, internal/ conference presentations, publications, regulatory dossiers reflecting ongoing or completed work
  • Participate as a subject matter authority in relevant interactions with partners including regulatory evidence generation strategy and labeling interactions

Essential

  • Combination of academic training and practical experience in outcomes research. This may consist of:
  • Doctoral degree (e.g., Ph.D., Sc.D. or D.Ph..) in a relevant subject area such as, but not limited to, health services research, health outcomes research, epidemiology, pharmacy administration, public health, economics, statistics or decision sciences, plus three years practical experience
  • Clinical degree (e.g., in medicine, pharmacy, nursing) and a master’s degree in a related subject area (as noted above), plus eight years practical experience
  • Master’s degree in a related subject area (as noted above), plus ten years practical experience
  • Significant 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.
  • Solid understanding of Patient Focused Drug Development (PFDD) FDA Guidance documents and other relevant mentorship documents and standard methodologies to capture patient’s experience in drug lifecycle
  • Conceptual, analytical and critical thinking
  • Creative, innovative, solution-focused
  • Curious, accepts new ways of problem solving, new ideas, new ways of working
  • Strong social skills and ability to establish relationships

Desirable

  • Conducting of outcomes research studies, and the communication of study findings to internal and external audiences
  • Expertise and 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 handle a program of concurrent activities
  • Resilience – ability to overcome and empower others in the face of a changing environment



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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