Head of Clinical Outcomes Assessment, Oncology R&D
AstraZenecaNew york city, more...Update time: July 1,2020
Job Description

We are seeking a candidate to join our Oncology R&D Digital Health team, focused on documenting the patient benefit of AZPLP’s new medicines to contribute to the successful development and commercialization of new, innovative therapies across the oncology portfolio.

Advances in digitalization, data and advance analytics are changing industries at pace with the pharma industry showing signs of movement. The Digital Health Market will grow exponentially over the next 3 years, with new applications in digital showing in phase 3 studies significant benefits for patients including overall survival in Cancer. Digital Health R&D’s ambition is to transform healthcare, powered by digital, science and collaborations, to deliver the healthcare outcomes and experience that patients care about the most. This role would focus on applying novel measurement science to R&D trials to best document the patient benefit of our novel therapies.

The Digital Health Oncology R&D journey incorporates 2 key stages:

Stage 1 – advanced, redefine clinical trials and digital health to improve overall patient experiences and outcomes, example redefining patient populations, remote clinical trials, patient apps to reduce/manage adverse events and improve patient outcomes (OS), using data from EHMr and RWE instead of control arms, and through PROs and continuous patient monitoring, creating new end points enabling studies in earlier stages of disease (ctDNA changes) prolonging significantly patients’ lives

Stage 2 – future-readiness, reimagine healthcare, examples, AZ as a healthcare provider beyond medicines for certain indications (example: Breast Cancer, proving monitoring, predictive analytics and therapies for improved outcomes), full integration of Multiomics (imaging, genomics, proteomics …) to better predict and significantly improve patients’ health

What you’ll do:

  • Conduct qualitative and quantitative research to inform development of conceptual disease-models to understand unmet clinical need and potential therapeutic preferences to inform drug development
  • Develop, assess and interpret Clinical Outcome Assessments (COAs), including Patient-Reported Outcomes (PROs), Observer-Reported Outcomes (ObsROs) and Clinician-Reported Outcomes (ClinROs), and performance outcome (PerfO) measures to derive clinical benefit during the clinical development and commercialization of new molecules, including development and validation of PRO and health-related quality of life instruments for clinical development programs and inclusion of COA endpoint strategy (including needs from key stakeholders, such as; regulators, payers, healthcare professionals and patients) in all major deliverables such as: clinical development plans, study protocols, strategic and operational reports, and regulatory labelling interactions
  • Generate patient insights about disease and treatment, and lead the development of COA measurement strategies to support clinical development, post-authorization and enable successful commercialization of our new medicines
  • Provide expert advice on PRO measurement needs to cross-functional molecule teams and ensure inclusion in comprehensive evidence generation plans and their appropriate implementation, as well as for novel, multi-modality digital solutions
  • Prepare, review, and publish scientific reports, internal/ conference presentations, publications, regulatory dossiers reflecting ongoing or completed work

Essential for the role

  • Combination of academic training and practical experience in oncology outcomes research, as well as, successful line management. This may consist of:
    • Doctoral degree (e.g., Ph.D., Sc.D. or Dr.P.H.)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 eight years practical experience
    • Clinical degree (e.g., in medicine, pharmacy, nursing) and a masters degree in a related discipline (as noted above), plus eight years practical experience
    • Masters degree in a related discipline (as noted above), plus ten years practical experience
  • Practical experience (number of years as noted above) in performing outcomes research, in any setting, including life sciences company, research organization, academic institution or governmental agency
  • A minimum of 5 years of Patient Reported Outcomes experience
  • Demonstrated experience in interpreting statistical analysis and communicating scientific evidence, with strong written and verbal presentation skills
  • Strong working knowledge of Patient Focused Drug Development (PFDD) Guidance documents and other relevant guidance documents and best practices
  • Familiarity with the role and importance of outcomes research in the multi-disciplinary drug development and commercialization environment and process (involving multiple stakeholders in a matrixed environment

Desirable for the role

  • 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
  • Leading high performing teams, influencing teams of complex stakeholders, and driving decisions
  • Demonstrated expertise in patient-reported outcomes/health-related quality of life assessment
  • Experience in conducting outcomes research in different geographic regions and interacting with regulator and policy-makers

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.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

Date Posted

01-Jul-2020

Closing Date

29-Aug-2020

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 authorization and employment eligibility verification requirements.

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