MSD
Director, Outcomes Research - Vaccines
MSD, Rahway, New Jersey, us, 07065
Job DescriptionUnder the guidance of a Senior Director, within Outcomes Research (OR) the incumbent has the following responsibilities:Development of the integrated evidence strategy to support Health Technology Assessment (HTA)/ reimbursement/ National Immunization Technical Advisory Groups (NITAG) evaluations.
Development of overall Real World evidence strategies, for one or more in-line and/or developmental drugs and/or vaccines on a worldwide basis.
Development and implementation of Outcomes Research (OR) and Real-World evidence programs to meet the value evidence needs of payers, advisory committees' health systems, and clinicians.
The incumbent can generate these plans based on direct interactions with HTA agencies, HTA/reimbursement experts and our company's country affiliates to obtain in-depth understanding of country specific HTA/reimbursement needs for the product and gain input on research design and implementation of retrospective database studies, assessment of patient reported outcomes, epidemiological studies and economic modeling.The Director also works closely with Product Development Teams, Franchise Teams, Regional Product Directors, our company's affiliates, Public Affairs, and Medical Education to ensure value evidence programs are consistent with marketing strategies in key countries. Represents OR on one or more Value and Implementation (V&I) and provides leadership in developing the outcomes research strategies and plans for developmental compounds and obtains cross-divisional senior management approval.Critically assesses drivers and barriers to reimbursement and market access and identifies value evidence needs to provide strategic input into clinical and market development programs. Brings strong payer and HTA/reimbursement focus into the Product Development Team(s).Develops the integrated evidence strategy including HTA/OR strategy and generates evidence for HTA/reimbursement purposes.Develops and evaluates health programs leveraging different parts of health care systems that can enhance value and use of our company's products.Implements programs to document the burden and cost of diseases, unmet medical need, patient reported outcomes (PRO) and the value of drug therapy as outlined in the OR planning process and generates data on a worldwide basis to support pricing and reimbursement.Develops value evidence deliverables (e.g., global value dossier, health economic evaluations) and their adaptation to generate country-specific data supporting pricing and reimbursement.Works closely with the V&I team members to develop OR plans for our company's in-line and developmental products based on the regulatory, marketing and reimbursement environments on a worldwide basis, including the local needs of the US Market. Works with our Research Division colleagues, our company's affiliates and consultants to write, coordinate, and validate as required, study designs, protocols, measurement questionnaires, case report forms, data analysis plans, and final reports/publications.Works with our company Investigator Study Program Committee to evaluate outcomes research study protocols for studies in local markets.Supports our company's affiliates to understand local needs, adapt health economic evaluations, customize Outcomes Research documents such as protocols and reimbursement dossier, which includes the development of the worldwide template document including global value dossier and input forms, design of data collection forms for customization to countries, and in collaboration with our company's affiliates, adaptation of the document according to local requirements.Works closely with other departments to effectively develop/communicate Outcomes Research findings/value evidence and support data and consistent messages throughout our company and to external customers.Responsible for maintaining awareness of scientific developments within his/her areas of expertise, both in terms of new methodology and new activities to establish communications with key outcomes research opinion leaders.Leverages other groups within OR to develop and execute OR plans, including Market Partners, Data Sciences and Insights, and Pharmacoepidemiology.Builds relationships with health economic and outcomes research experts worldwide.Other activities:Provide scientific oversight and mentorship to more junior members of the team.
Present research plans and results to internal review and governance committees; to external experts and agencies (e.g. UK HSA) and at scientific conferences.
Maintain recognition as an expert in his/her field; publish independent scientific research in major journals, participate in and present at scientific meetings and conferences, and serve as a peer reviewer for scientific journals.
Competencies and skills:In-depth understanding of HTA/reimbursement and market access needs in key global markets.
5+ years post PhD or 7+ years post Master's degree of relevant experience in the areas of health economics, outcomes research, market access, HTA or related field.
Demonstrated expertise in the design and implementation of epidemiological or health economic studies.
Demonstrated expertise in the fields of outcomes research, health services research, epidemiology or health economics, and/or health technology assessment.
A track record of scientific presentations and publications.
Creative problem-solving and excellent communication skills (oral and written).
Willing to travel (up to 10% of the time).
Fluent spoken and written English.
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Development of overall Real World evidence strategies, for one or more in-line and/or developmental drugs and/or vaccines on a worldwide basis.
Development and implementation of Outcomes Research (OR) and Real-World evidence programs to meet the value evidence needs of payers, advisory committees' health systems, and clinicians.
The incumbent can generate these plans based on direct interactions with HTA agencies, HTA/reimbursement experts and our company's country affiliates to obtain in-depth understanding of country specific HTA/reimbursement needs for the product and gain input on research design and implementation of retrospective database studies, assessment of patient reported outcomes, epidemiological studies and economic modeling.The Director also works closely with Product Development Teams, Franchise Teams, Regional Product Directors, our company's affiliates, Public Affairs, and Medical Education to ensure value evidence programs are consistent with marketing strategies in key countries. Represents OR on one or more Value and Implementation (V&I) and provides leadership in developing the outcomes research strategies and plans for developmental compounds and obtains cross-divisional senior management approval.Critically assesses drivers and barriers to reimbursement and market access and identifies value evidence needs to provide strategic input into clinical and market development programs. Brings strong payer and HTA/reimbursement focus into the Product Development Team(s).Develops the integrated evidence strategy including HTA/OR strategy and generates evidence for HTA/reimbursement purposes.Develops and evaluates health programs leveraging different parts of health care systems that can enhance value and use of our company's products.Implements programs to document the burden and cost of diseases, unmet medical need, patient reported outcomes (PRO) and the value of drug therapy as outlined in the OR planning process and generates data on a worldwide basis to support pricing and reimbursement.Develops value evidence deliverables (e.g., global value dossier, health economic evaluations) and their adaptation to generate country-specific data supporting pricing and reimbursement.Works closely with the V&I team members to develop OR plans for our company's in-line and developmental products based on the regulatory, marketing and reimbursement environments on a worldwide basis, including the local needs of the US Market. Works with our Research Division colleagues, our company's affiliates and consultants to write, coordinate, and validate as required, study designs, protocols, measurement questionnaires, case report forms, data analysis plans, and final reports/publications.Works with our company Investigator Study Program Committee to evaluate outcomes research study protocols for studies in local markets.Supports our company's affiliates to understand local needs, adapt health economic evaluations, customize Outcomes Research documents such as protocols and reimbursement dossier, which includes the development of the worldwide template document including global value dossier and input forms, design of data collection forms for customization to countries, and in collaboration with our company's affiliates, adaptation of the document according to local requirements.Works closely with other departments to effectively develop/communicate Outcomes Research findings/value evidence and support data and consistent messages throughout our company and to external customers.Responsible for maintaining awareness of scientific developments within his/her areas of expertise, both in terms of new methodology and new activities to establish communications with key outcomes research opinion leaders.Leverages other groups within OR to develop and execute OR plans, including Market Partners, Data Sciences and Insights, and Pharmacoepidemiology.Builds relationships with health economic and outcomes research experts worldwide.Other activities:Provide scientific oversight and mentorship to more junior members of the team.
Present research plans and results to internal review and governance committees; to external experts and agencies (e.g. UK HSA) and at scientific conferences.
Maintain recognition as an expert in his/her field; publish independent scientific research in major journals, participate in and present at scientific meetings and conferences, and serve as a peer reviewer for scientific journals.
Competencies and skills:In-depth understanding of HTA/reimbursement and market access needs in key global markets.
5+ years post PhD or 7+ years post Master's degree of relevant experience in the areas of health economics, outcomes research, market access, HTA or related field.
Demonstrated expertise in the design and implementation of epidemiological or health economic studies.
Demonstrated expertise in the fields of outcomes research, health services research, epidemiology or health economics, and/or health technology assessment.
A track record of scientific presentations and publications.
Creative problem-solving and excellent communication skills (oral and written).
Willing to travel (up to 10% of the time).
Fluent spoken and written English.
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