Associate Director, Clinical Outcomes Assessment - Evinova

Gaithersburg, MD

Employer:	AstraZeneca
Job Type:	Full Time
Description
Evinova is a health-tech business, accelerating the delivery of better health outcomes by propelling the life sciences sector forward in digital health, from the inside. Through our application of science-based expertise, evidence-led rigour, and human insight, our digital solutions are deliberately designed so that everyone can reach better health outcomes together. Evinova is a health-tech business within the AstraZeneca Group. 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/interventions. Digital health, the point at which healthcare, technology, data and analytics converge, is the subject of phenomenal 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 Associate Director in the COA Measurement Science, Centre of Excellence should have experience in 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 Associate Director will be responsible for providing qualitative and quantitative measurement support for the development and execution of patient-centered measurement strategy and dissemination of its findings to key collaborators, 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 and exploration of unmet measurement need by conducting literature reviews and/or qualitative research studies, 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), selection of data collection strategy and implementation in clinical research or real world setting, collaboration for data analyses and interpretation and audience-adapted publications. The Associate Director will be encouraged to partner with scientific leaders within the organization to identify specific areas of interest for professional development, with the ultimate goal of becoming a recognized leader in the COA/digital health field. What you'll do As the Associate Director, 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 and exploration of unmet measurement need, endpoints capturing symptoms, function, or quality of life evolution overtime to inform disease progression or tolerability) including study design/oversight and data collection 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 minimal supervision, contribute to the exploration 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 collaborators, and data collection to inform decision making related to the inclusion of COA endpoints and findings in major deliverables such as: clinical development plans, study protocols, and strategic and operational reports. With support from line management, partner with scientific leaders within Digital Health Oncology to identify, pursue, and develop independent scientific expertise within the COA and digital health fields. Collaborate and partner with key internal collaborator 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 minimal supervision. Essential for the role Combination of academic training and practical experience in outcomes research. This may consist of: Highly Preferred: Doctoral degree (e.g., Ph.D., Sc. D. or Dr.P.H.) in a relevant field 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 OR: Clinical degree (e.g., in medicine, pharmacy, nursing, or equivalent) and a masters degree in a related field (as noted above), plus three years practical experience OR: Masters degree in a related field (as noted above), plus three years practical experience OR: Bachelors degree in a related field (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. Experience in conducting literature reviews Working knowledge of Patient Focused Drug Development (PFDD) FDA Guidance documents and other relevant mentorship documents and standard processes to capture patient's experience in drug lifecycle Project management and vendor management skills Conceptual, analytical and critical thinking Creative, innovative, solution-focused Curious, embraces new ways of problem solving, new ideas, new ways of working Strong communication skills and ability to establish 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 qualitative interviews with patients and clinicians and performing qualitative data analysis 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 Evinova (AstraZeneca)? Evinova draws on AstraZeneca's deep experience developing novel therapeutics, informed by insights from thousands of patients and clinical researchers. Together, we can accelerate the delivery of life-changing medicines, improve the design and delivery of clinical trials for better patient experiences and outcomes, and think more holistically about patient care before, during, and after treatment. We know that regulators, healthcare professionals, and care teams at clinical trial sites do not want a fragmented approach. They do not want a future where every pharmaceutical company provides its own, different digital solutions. They want solutions that work across the sector, simplify their workload, and benefit patients broadly. By bringing our solutions to the wider healthcare community, we can help build more unified approaches to how we all develop and deploy digital technologies, better serving our teams, physicians, and ultimately patients. Evinova represents a unique opportunity to deliver meaningful outcomes with digital and AI to serve the wider healthcare community and create new standards for the sector. Join us on our journey of building a new kind of health-tech business 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. The annual base pay for this position ranges from $141,229 - $211,843 . Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. 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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Associate Director, Clinical Outcomes Assessment - Evinova

Gaithersburg, MD

Description