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Senior Director, Head of Clinical Outcomes Assessments (COA) Measurement Science - Evinova

Location Gaithersburg, Maryland, United States Waltham, Massachusetts, United States Job ID R-210041 Date posted 30/09/2024

We are building out a best-in-class Measurement Science team to support R&D as well as digital solutions including digital therapeutics, which will be part of the future of measurement science and analytics to support novel endpoints/interventions.  

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 experience-driven 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.

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

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. 

A Senior Director, Head of Measurement Science will provide subject matter expertise and leadership for the development and use of clinical outcomes assessments (COA) such as traditional survey-like instruments using rating or ranking scales and/orCOA along with novel sensor/wearable data capture tools to inform identification and/or evaluation of symptoms, function, health-related quality of life, or other patient-centric concept of clinical benefit/risk throughout the oncology drug development lifecycle.  The SeniorDirector, Head of Measurement Science will be responsible for providing strategic direction on qualitative and quantitative measurement expertise for the development and execution of patient-centered measurement strategies and dissemination of 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 risks.  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. The Senior Directorshould be published as an expert within this area of specialization.The SeniorDirector, Head of Measurement Sciencewill be expected to partner with scientific leaders within the organization and externally 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 SeniorDirector, Head Measurement Scienceyou will play a pivotal role in leading our scientific capabilities and developing talent to make a positive impact on changing patients’ lives through the following:

  •  ​You will serve as a subject matter expert and recognized leader 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 inform disease progression or tolerability)
  • Partner with scientific leaders to identify, pursue, and develop independent scientific expertise within the COA and digital health fields. 

  • You will be responsible for 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.

  • You will contribute to the development or selection and interpretation of COA in clinical research to inform clinical benefit/risk 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.

  • You will collaborate and partner with key internal stakeholder colleagues to ensure priorities and strategies are aligned.

  • You will prepare, review, and publish scientific reports, internal/ conference presentations, publications, regulatory dossiers reflecting ongoing or completed work and be recognized as a leader in the field of measurement science

  • You will contribute to the development of the team with opportunity to manage direct reports

Minimum Qualifications:

  • Combination of academic training and practical experience in outcomes research. This may consist of: 

  • Masters degree in a related discipline , plus 10 years practical experience OR

  • Bachelors degree in a related discipline, plus 12 years practical experience

  • Significant experienceand recognized expertisein 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, as well as experience applying this knowledge in a clinical research setting. 

  • Experience collaborating with cross-functional partners with varying levels of knowledge and experience in COA and Digital health sciences. 

  • Sufficient understanding of basic research methodologies and analytic principles that intersect with measurement science in clinical research settings (including but not limited to comparative study designs, biostatics and psychometrics), to effectively communicate, partner, and collaborate with SMEs in these fields. 

  • Experiencepartnering with and overseeing/mentoring junior scientists. 

  • Conceptual, analytical and strategic thinking

  • Creative, innovative, and solution-focused

  • Curious, embraces new ways of problem solving, new ideas, and new ways of working

  • Strong communication skills, the ability to build relationshipsamong cross-functional partners and stakeholders, and the ability to influence without authority.  

Desirable Qualifications:

  • Doctoral degree (e.g., Ph.D., Sc.D. or Dr.P.H.) in a relevant field, along with practical experience

  • Conducting outcomes research studies, and the communication of study findings to internal and external audiences

  • Expertise and experience in oncology with the development, selection, andpsychometric evaluation of PRO instruments used in clinical studies

  • Experience managing junior scientists

  • Experience 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.  Evinovarepresents 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.

So, what’s next!

Are you already envisioning yourself joining our team? Good, because we can’t wait to hear from you.

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

Learn more about Evinova www.evinova.com

The annual base pay for this position ranges from $225,068 to $337,603. 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.

10000554 G CDHE

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.