The Patient Centered Science Director will set and lead TA-level (and underlying project-level) PRO and Patient experience strategies and direct delivery of such plans to ensure high quality evidence supporting products’ regulatory approval, reimbursement and commercialization.

The incumbent will be responsible for driving high quality evidence messages and claims by working with assigned TA(s) (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/ Clinical Outcome Assessment (COA) as endpoint and as description of patient experience;
• Investigate to what extent PRO and 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 PCS strategic recommendation;
• Ensure, when relevant, that new instruments and endpoints are developed and fit-for-purpose and that new innovative methods are developed to meet all key stakeholder needs;
• Provide PRO/COA/patient experience strategic advice on the planning, use and promotion of new or existing instruments and endpoints for AZ products to ensure consistency, coordination and quality within and across projects.

The incumbent will lead patient interviews and other appropriate ways to obtain input as the foundation for the PCS and patient experience strategies. The PCS director will interact with regulatory authorities and key external experts, as well as with relevant AZ cross-functional teams (eg, GPTs, CPTs, GMTs, Payer Teams), to provide PCS related leadership to assigned projects, and will be accountable for TA PRO standards, the input to TPPs/TPC and clinical plans. The role holder will ensure that fit-for-purpose PCS recommendations are based on scientific patient input and insight and documentation have been completed and assembled for PRO dossier discussions and submissions.

The role holder will participate as an expert with cross-functional teams (eg, IPT, GPT, Payer Team, where appropriate), with the R&D global project teams to ensure PROs are planned and discussed with regulatory authorities and with appropriate timing and context to facilitate decision making. The role will lead the TA PRO/COA regulatory discussions, plans, submissions and work with colleagues in relevant markets to support payer evidence needs (such as utility and patient preference measurements). The role holder will also work with BioPharmaceuticals Medical to leverage the PRO and patient experience information to make it available and impactful to patients, prescribers, payers and regions.

Accountabilities/Responsibilities:

• Deliver robust TA and project PRO/COA regulatory recommendations globally to meet regulatory, payer and patient needs
• Deliver expert input on PRO needs to TPPs, TPCs and secure 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.
• Through appropriate internal and external communications channels (eg peer-reviewed scientific journals, presentations, conferences, regulatory discussion and early and late PRO dossier development) increase PCS knowledge and effectiveness to drive sustainable patient-centered approaches and PCS input to the drug development value chain.
• 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 PCS measurement in the external scientific/regulatory community
• 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.
• Provide expertise to resolve issues identified by CPTs, GPTs, GMTs, IPTs and Payer Teams
• Interact with cross-functional team members at a project level
• Supports GPT and CPT in the design and interpretation of clinical studies and programs as required
• Management responsibilities for applicable vendors within or in adjacent projects (e.g. budget planning and record keeping, contract management) in collaboration with procurement
• Supervise vendors and/or study team personnel and associates in PRO/COA instrument development and/or administration.
• Identifies and uses appropriate external PRO/COA data sources and literature references.
• Prepares vendor proposal requests for PRO/COA work projects and manages selection process.
• Budgeting responsibility for assigned subprojects within the development projects.
• Responsible for project management in collaboration with academic researchers and clinical research organizations to time, budget, and quality. Participates in preparation for investigator meetings including work materials & presentations.
• Prepares technical presentations
• Prepares PRO/COA data as background materials and registration pack for discussion with regulatory authorities.
• Advances knowledge about PCS research and the impact of pharmaceutical product development.
• Advance expertise in PCS research through presentations, publications.
• Interaction with regulatory personnel and HTA authorities to prepare background materials; instrument development and validation research for consideration by eg, NICE, EMA, FDA

Minimum Requirements –Education and Experience:

• Bachelor’s degree in clinical, biological, or social sciences
• Masters 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 PCS scientific work
• Excellent knowledge in clinical development and research study designs and interpretation.
• Good understanding of qualitative and quantitative analyses applicable to patient insights, feeling and functioning
• 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
• Experience in partnering and collaborating with external vendors/agencies
• Open to periods of extensive travel

Skills and Capabilities:

• In-depth professional or expert knowledge of 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.
• Knowledge of international healthcare systems and their changing needs for PRO/COA information.
• 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 threats and opportunities for PCS 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
• Ability to define clear scope of project and provide strategic consultative support .
• Ability to look for and champion more efficient and effective methods/processes
• Excellent written and verbal communication skills,
• Integrity and high ethical standards

Internal and External Contacts/Customers:

• R&D
• BioPharmaceuticals Medical (BPM) Therapy Area VPs, Medical Affairs Leads (MAL), BPM Evidence
• GMAP, GPPS
• External consultants
• Regulatory agencies and academic institutions

Reporting Relationship:

• Direct Reports: None
• Indirect Reports: None

Budget responsibility:

• Contributes to Patient Centered Science team budget management

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 recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together. Interested? Come and join our journey.

So, what’s next!

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