Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Director, Outcomes Research
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Upper Gwynedd, PA
Job # OUT000411
Under the guidance of an Executive Director, within the Center for Observational and Real World Evidence (CORE) the incumbent has the following responsibilities 1.) development of the integrated evidence strategy to support HTA/ reimbursement/ NITAG evaluations; 2.) development of overall Real World evidence strategies, for one or more in-line and/or developmental Merck drugs and/or vaccines on a worldwide basis and 3.) 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 MSD 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.
These activities include global responsibilities that are aligned with Customer Business Lines strategies and direct market responsibilities in the U.S. aligned with the U.S. Market strategy. The incumbent contributes to product development and marketing strategies to ensure that product value is defined and developed.
The Director also works closely with Product Development Teams, Franchise Teams, Regional Product Directors, MSD affiliates, Public Affairs, and Medical Education to ensure value evidence programs are consistent with marketing strategies in key countries. Represents CORE on one or more Value and Evidence Sub-teams (VEST) and provide leadership in developing the OR 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 Merck 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 VEST team members to develop OR plans for Merck 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 Merck Research Labs colleagues, MSD 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 the Merck Investigator Study Program Committee to evaluate outcomes research study protocols for studies in local markets. Supports MSD 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 MSD 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 Merck 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 CORE 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.
Presents outcomes research data at international/national congresses and publishes articles in scientific journals.