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Lieu: Gaithersburg, Maryland, États-Unis Cambridge, Massachusetts, États-Unis Göteborg, Comté de Västra Götaland, Suède
ID de l'offre 13339852
Date de publication: 09/16/2019

AstraZeneca is committed to putting patients first. This strong focus on patients shapes how we manage all aspects of our business. The Patient Centered Science (PCS) group plays an integral role in fulfilling this commitment by developing strategies to capture patient experience and generating impactful evidence to demonstrate the value of our medicines and support decision making by regulators, payers, patients physicians.

We are expanding our team to include Patient Centered Science Directors to develop optimized strategies for generating patient experience data to support the evidence needs of payers and support reimbursement of our medicines. The role is dedicated to our therapeutic area; Cardiovascular, Renal and Metabolism (CVRM).

The role will require an in-depth understanding of the global payer and health technology assessment environment, experience developing strategies to meet payer evidence needs, and experience with patient-centered outcomes research within the context of pharmaceutical development.

As a PCS director you will lead the development of patient experience strategies optimized to meet the needs of payers and develop innovative ways to highlight the value of patient experience data to demonstrate the value of our medicines to payers. This includes understanding how to utilize the PCS evidence collected, and how to present those in the most powerful and impactful way to payers as well as other key stakeholders within AZ that is working within this field. In the role you will 1) represent PCS on payer topics as they relate to our functional remit on patient experience 2) work with PCS colleagues to optimize strategies and build payer evidence generation capability within the team 3) work cross-functionally and with local markets to understand needs and apply patient experience data in a way that is relevant to payers. For the right person there is also an opportunity to influence, develop and shape the position.  

You will also set and lead TA and study specific PRO strategies to represent the patient experience to regulators, patients and HCPs.

The incumbent will be responsible for driving high quality evidence claims by working with assigned TA, focusing on projects within the metabolic field (and their underlying projects) across the development cycle to:

  • Determine and deliver guidance on which disease/therapy areas and early projects will need a PRO as endpoint and as description of patient experience;
  • Investigate to what extent PRO and Clinical Outcome Assessment (COA) endpoints are developed, fit-for-purpose and approved by Regulatory Authorities and also how well they will meet AZ project needs, to provide the most appropriate PRO strategic recommendation to meet all key stake holder needs

As a PCS director you will interact with regulatory authorities, payers and key external experts, as well as with relevant AZ cross-functional teams, to provide PRO related leadership to assigned projects, and will be accountable for TA PCS standards, the input to TPPs/TPC and clinical plans. 

 Key Accountabilities/Responsibilities                                                                                           

  • Develop ways of working and make a strategy for how to best utilize collected PCS evidence to support payer and reimbursement discussion.
  • Develop stronger relationship with internal groups that work with payer and reimbursement to support and deliver to the changing business need.
  • Develop relationships with appropriate AZ teams as well as with KEEs and collaborative groups (within the relevant disease area) to enhance AZ’s reputation of PRO measurement in the payer community.
  • Deliver robust TA and project PCS regulatory recommendations globally to meet regulatory, payer and patient needs.
  • Deliver expert input on PRO needs to TPPs, TPCs and support PRO dossier and briefing document evidence within the clinical plans and regulatory submissions.
  • Ensure appropriate PRO and COA input is included at the design stages of clinical programs and drive appropriate data collection plans and analyses to ensure high quality interpretation of the resulting data.
  • Proactively and independently contribute to research planning process and resolution of complex issues, which may impact investment decisions and the external acceptance of evidence for product.
  • Project management and expert consultation supporting patient centered/PRO measurement in clinical programs, and dissemination of results and messages to all key stakeholders in all different phases (design to interpretation).
  • Support regulatory and payer interactions by developing patient experience evidence for inclusion in submissions and support teams via participation in meetings with decision makers (e.g. FDA, EMA, NICE, G-BA, etc.)
  • Advances knowledge about PRO/COA research and the impact of patient experience data to support pharmaceutical product development.
  • Advance expertise in PRO/COA research through presentations, publications.

Minimum Requirements –Education and Experience

  • Bachelor’s degree in clinical, biological, or social sciences
  • Master’s degree in relevant field (outcomes research, health services research, epidemiology, health policy or related fields)
  • Doctoral degree in relevant field preferred
  • Minimum of 5 years experience in the biopharmaceutical industry
  • Relevant experience of COA/PRO scientific work
  • Excellent knowledge in clinical development and research study designs and interpretation.
  • Good understanding of qualitative and quantitative analyses to gain insights on patient experience
  • Demonstrated track record in delivering a new capability or driving a change effort.
  • Effectiveness in a scientific advisory role involving both strategic and tactical elements
  • Knowledge of AZ’s prioritized disease and therapeutic areas
  • Open to periods of travel

Skills and Capabilities

  • In-depth professional or expert knowledge of payer and the payer environment, with comprehensive understanding of payer field.
  •  Knowledge of international healthcare systems and their changing needs for PRO/COA information. 
  •  PRO /COA and its application to pharmaceutical development at an international level.
  • Comprehensive understanding of the pharmaceutical industry and regulatory requirements from a global perspective and product development processes at all life cycle stages. 
  • Strong knowledge of legal and regulatory environment influencing clinical development plans, labeling and promotional claims.
  • Provide innovative scientific knowledge and leadership in patient centered evidence work teams.
  • Leadership skills and problem-solving capability as demonstrated by ability to evaluate challenges and opportunities for PRO strategy and modify as appropriate. 
  • Well-developed conceptual thinking with capability to access internal and external resources for advice.
  • Proactive application of therapeutic area and disease treatment knowledge.
  • Able to implement projects including interactions with key stakeholders with high degree of autonomy.
  • Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills
  • Integrity and high ethical standards

Are you ready to make a difference? Send in your application, and we’ll make it happen together.

For more information about the position please contact: Anna Niklasson, Group Director, Patient Centered Science: CVRM at anna.niklasson@astrazeneca.com or +46 31 776 20 02

Welcome with your application no later than October 20, 2019.

Patient Centered Science Director with payer focus
Développement clinique

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