BioSpace
Associate Director, Patient-Centered Outcomes Research (Oncology)
BioSpace, Waltham, Massachusetts, United States, 02254
Overview
Associate Director, Patient-Centered Outcomes Research (Oncology) is the design and execution of strategically-focused and innovative patient experience data (PED) evidence to support optimization of product registration, access & reimbursement, and clinical practice in collaboration with HEOR Strategy and other functions (e.g., Clinical Development & Operations, Regulatory, Commercial). The Associate Director will support multiple programs across therapeutic areas and cultivate strong partnerships to enable effective cross-functional collaboration with internal groups including HEOR-Strategy, Clinical Development and Operations, Biostatistics, Regulatory Affairs, Medical Affairs, and the Commercial organization, as well as external partners (e.g., industry consortiums, key opinion leaders, research organizations, patient advocacy groups). The role represents HEOR at global regulatory and payer/HTA meetings and may lead or support negotiations to drive internal strategy and alignment with global regulatory & reimbursement agencies. The role serves as a subject matter expert (SME) on PED and patient-centered measurement strategies within HEOR and AbbVie to drive a patient-centric culture and adoption/uptake of standards and best practices for PED. The Associate Director is responsible for several programs across AbbVie’s portfolio (spanning multiple products/indications). Additional responsibilities include developing annual strategic planning of PED aligned with TA/asset strategy and managing multiple projects and vendors to execute PED for their respective TA responsibilities. Responsibilities
Responsible for execution of global PED evidence generation and stakeholder engagement strategies that encompass innovative research aligned with overall asset strategy across multiple therapeutic areas. Lead management of projects to ensure timely execution of PED research to characterize patient outcomes, identify patient preferences and unmet needs, inform patient-focused measurement strategies, and develop innovative patient-relevant outcomes measures and endpoints to differentiate AbbVie’s portfolio and meet business and global needs. Support alignment of strategy with HEOR-Strategy counterparts and communicate strategy and results cross-functionally to key cross-functional teams to facilitate alignment and integration of PED plans into the broader Integrated Evidence Plans. Ensure scientific quality and integrity of COA research through development of rigorous qualitative and quantitative study proposals, protocols, analysis plans and reports. Lead integration of COA measurement strategy into clinical development programs through trial program support (e.g., protocol/SAP content development, results interpretation and CSR development) and ensure appropriate implementation of COAs on eCOA platforms in global programs; lead development, validation, and implementation of COAs measures for RCTs / observational studies. Lead/contribute to strategy and development of content for regulatory and reimbursement submissions regarding PED and patient-relevant endpoints; lead/participate in regulatory and reimbursement discussions and negotiations to optimize registration approval, product labeling & promotion and patient access decisions. Develop strategic scientific communications plans including submission and presentation of research in peer-reviewed journals and at medical/methodological congresses. Serve as internal SME on technical specialty areas to identify new methodologies and advancements in the field (e.g., COA methods, regulatory requirements to obtain COAs on labels, industry trends). Develop and deliver standards/best practices and educational resources for functions across AbbVie to drive the integration of patient voice in development programs. Qualifications
Advanced degree in Psychology, Epidemiology, Statistics, Public Health, Health Economics and Outcomes Research (HEOR) or related discipline (MS, MPH, PharmD, PhD) preferred. Minimum of 5 years of experience in pharmaceutical industry or consulting in patient experience data research, clinical outcome assessment / patient-reported outcome development, psychometric validation, and medical product development and trial design. Demonstrated ability in evaluation & development of PED from conceptualization through negotiations with global authorities. Experience in preparing regulatory & HTA submissions. Excellent interpersonal, written and verbal communication skills; ability to influence across multiple internal and external stakeholders. Experience managing multiple priorities in a rapidly changing environment; ability to work in a complex global matrix. Travel: up to 15% travel. Additional Information Applicable to applicants in locations with pay disclosure requirements under state or local law. We offer a comprehensive benefits package and incentive programs. AbbVie is an equal opportunity employer. Linked references and accommodations information are available in the original posting.
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Associate Director, Patient-Centered Outcomes Research (Oncology) is the design and execution of strategically-focused and innovative patient experience data (PED) evidence to support optimization of product registration, access & reimbursement, and clinical practice in collaboration with HEOR Strategy and other functions (e.g., Clinical Development & Operations, Regulatory, Commercial). The Associate Director will support multiple programs across therapeutic areas and cultivate strong partnerships to enable effective cross-functional collaboration with internal groups including HEOR-Strategy, Clinical Development and Operations, Biostatistics, Regulatory Affairs, Medical Affairs, and the Commercial organization, as well as external partners (e.g., industry consortiums, key opinion leaders, research organizations, patient advocacy groups). The role represents HEOR at global regulatory and payer/HTA meetings and may lead or support negotiations to drive internal strategy and alignment with global regulatory & reimbursement agencies. The role serves as a subject matter expert (SME) on PED and patient-centered measurement strategies within HEOR and AbbVie to drive a patient-centric culture and adoption/uptake of standards and best practices for PED. The Associate Director is responsible for several programs across AbbVie’s portfolio (spanning multiple products/indications). Additional responsibilities include developing annual strategic planning of PED aligned with TA/asset strategy and managing multiple projects and vendors to execute PED for their respective TA responsibilities. Responsibilities
Responsible for execution of global PED evidence generation and stakeholder engagement strategies that encompass innovative research aligned with overall asset strategy across multiple therapeutic areas. Lead management of projects to ensure timely execution of PED research to characterize patient outcomes, identify patient preferences and unmet needs, inform patient-focused measurement strategies, and develop innovative patient-relevant outcomes measures and endpoints to differentiate AbbVie’s portfolio and meet business and global needs. Support alignment of strategy with HEOR-Strategy counterparts and communicate strategy and results cross-functionally to key cross-functional teams to facilitate alignment and integration of PED plans into the broader Integrated Evidence Plans. Ensure scientific quality and integrity of COA research through development of rigorous qualitative and quantitative study proposals, protocols, analysis plans and reports. Lead integration of COA measurement strategy into clinical development programs through trial program support (e.g., protocol/SAP content development, results interpretation and CSR development) and ensure appropriate implementation of COAs on eCOA platforms in global programs; lead development, validation, and implementation of COAs measures for RCTs / observational studies. Lead/contribute to strategy and development of content for regulatory and reimbursement submissions regarding PED and patient-relevant endpoints; lead/participate in regulatory and reimbursement discussions and negotiations to optimize registration approval, product labeling & promotion and patient access decisions. Develop strategic scientific communications plans including submission and presentation of research in peer-reviewed journals and at medical/methodological congresses. Serve as internal SME on technical specialty areas to identify new methodologies and advancements in the field (e.g., COA methods, regulatory requirements to obtain COAs on labels, industry trends). Develop and deliver standards/best practices and educational resources for functions across AbbVie to drive the integration of patient voice in development programs. Qualifications
Advanced degree in Psychology, Epidemiology, Statistics, Public Health, Health Economics and Outcomes Research (HEOR) or related discipline (MS, MPH, PharmD, PhD) preferred. Minimum of 5 years of experience in pharmaceutical industry or consulting in patient experience data research, clinical outcome assessment / patient-reported outcome development, psychometric validation, and medical product development and trial design. Demonstrated ability in evaluation & development of PED from conceptualization through negotiations with global authorities. Experience in preparing regulatory & HTA submissions. Excellent interpersonal, written and verbal communication skills; ability to influence across multiple internal and external stakeholders. Experience managing multiple priorities in a rapidly changing environment; ability to work in a complex global matrix. Travel: up to 15% travel. Additional Information Applicable to applicants in locations with pay disclosure requirements under state or local law. We offer a comprehensive benefits package and incentive programs. AbbVie is an equal opportunity employer. Linked references and accommodations information are available in the original posting.
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