Patient Report Outcomes, Senior Scientist

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Description: T he Senior Scientist, Patient Reported Outcomes (PRO) will set and lead TA-level (and underlying project-level) PRO 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 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 as a clinical endpoint; * 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; * Ensure, when relevant, that new instruments are developed and fit-for-purpose; * Provide PRO and COA strategic advice on the planning, use and promotion of new or existing instruments for AZ products to ensure consistency, coordination and quality within and across projects. The incumbent will interact with regulatory authorities and key opinion leaders, as well as with relevant AZ cross-functional teams (eg, CPTs, DIWGs, Payer Teams), to provide PRO related leadership to assigned projects, and will be accountable for TA PRO standards, the input to dTPPs/TPPs/TPC and clinical plans developed in the DIWG. The role holder will ensure that fit-for-purpose PRO recommendations and documentation have been completed and assembled for PRO dossier discussions and submissions. The role holder will participate as an expert within the DIWG and other cross-functional teams (eg, IPT, GPT, Payer Team, where appropriate), with the IMED and GMD 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 regulatory discussions, plans, submissions and work with GPED colleagues in relevant markets to support payer evidence needs (such as utility and patient preference measurements). Accountabilities: Deliver robust TA and project PRO regulatory recommendations globally to meet regulatory needs. Through the DIWG, deliver expert input on PRO needs to dTPPs, 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 programmes 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 PRO knowledge and effectiveness to drive sustainable patient-centered approaches and PRO input to the drug development value chain. Develop relationships with appropriate AZ teams as well as with KOLs and collaborative groups (within the relevant disease area) to enhance AZ's reputation of PRO 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, DIWG and PRO dossier development. Provide expertise to resolve issues identified by CPTs, DIWGs, GPTs, IPTs and Payer Teams. Interact with cross-functional team members at a project level Supports CPT and DIWG 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. Responsibilities: Supervise vendors and/or study team personnel and associates in patient reported outcome 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 CPTs/Payer Teams. 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 PRO/COA research and the impact of pharmaceutical product development. Advance expertise in PRO/COA 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 SEALD group and DDMAC departments. Internal and External Contacts/Customers Internal -- some examples of internal contacts/customers are : Project Management Medical Science Director CPT and/or Design & Interpretation Working Group Global Marketing and Sales Organization Medical Resources & External Scientific Affairs Payer Team and RWE and Payer Analytics Team External -- some examples of external contacts/customers are : Government reimbursement and pricing authorities CROs and Academic Investigators FDA SEALD, Agency for HealthCare Quality and Evidence Based Practice Centers, EMA, NICE, payers. Reporting Relationship If applicable, this section contains a list of positions that report to the position, either directly or indirectly Direct Reports - none Indirect Reports -- none Minimum Qualification Requirements Education: Bachelor's degree in clinical, biological, or social sciences Masters degree in relevant field (outcomes research, health services research, epidemiology, health economics, health policy or related fields) ... Doctoral degree in relevant field preferred Experience: Relevant experience of PRO scientific work, preferably quantitative as well as qualitative (including work within the pharmaceutical industry or related) Previous project management or personnel management preferred Significant previous project leadership experience in the generation of PRO evidence and strategic work 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 team. Leadership skills and problem solving capability as demonstrated by ability to evaluate threats 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. AstraZeneca Leadership Capabilities (target level 3) Passion for Customers Thinks Strategically Acts Decisively Drives Performance Works Collaboratively Develops People and Organization Payer and RWE Key Technical Capabilities Integrating value into Clinical Trial Design (target level Professional) Clinical Outcomes Assessment (target level Expert) Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation
Phama Job Categories: 
USA
Formulation and Development

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