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.
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.
Under the general direction of the Patient-Reported Outcomes & Study Endpoints (PRO&SE) group lead, the Principal Scientist has responsibility for supporting or co-leading global Clinical Outcomes Assessment (COA) endpoint strategies, including Patient-Reported Outcomes for specific product lines or disease areas by interacting with stakeholders within and outside of the Center for Observational and Real-World Evidence (CORE). The individual will co-lead or guide teams on the development, validation and interpretation of COA measures for inclusion in studies to support regulatory submissions, reimbursement evidence dossiers, payer interactions, and publications. The Principal Scientist will work closely with individuals from all CORE functions, Clinical Research, Regulatory Affairs, Biostatistics, and Operations to ensure COA endpoint strategies are consistent with, and executed and interpreted to support the product strategy.
Primary activities include but are not limited to:
- Develop global COA endpoint strategic plans in collaboration with Early Development Teams (EDTs), Value Evidence Sub-teams (VESTs) and Clinical Sub-teams (CST) to assure alignment with product franchise goals.
- Responsible for the execution and standardization of COA-related activities for at least one product line.
- Coordinate and lead the development, validation, interpretation and utilization of instruments aimed at measuring COAs in the context of clinical trials and/or observational studies.
- Provide guidance, create and/or review dossiers to be submitted to Regulatory Authorities and/or HTA agencies to assure consistency and alignment with COA strategies and represent Merck during these interactions
- Provide guidance on sections of protocols, CRFs, SAPs and reports related to COAs.
- Work closely with the clinical team and VEST to interpret results from COA endpoints included in clinical trials and observational studies
- Responsible for maintaining awareness of scientific, regulatory, and market access developments within his/her areas of expertise across Merck functional areas, both in terms of new methodology and new activities to establish communication with key outcomes research opinion leaders.
- Organize the collection of existing information on COAs used within CORE to facilitate selection and/or development of measures for new clinical trials;
- Provide training on COA-related topics to new CORE members and to other Merck departments as needed.
- Support or produce scientific communications (abstracts, poster presentations, podium presentations, manuscripts, etc.) and external communications (e.g., value evidence dossiers).
- Keep up-to-date with methodologies and guidelines (including those from Regulatory Authorities) and communicate findings to CORE groups as needed.
Education Minimum Requirement:
- Doctoral, Master's or Bachelor's Degree in Heath Services Research, Statistics, Psychometrics, Outcomes Research or closely related field
Required Experience and Skills:
- Experienced with PRO/COA requirements for regulatory and HTA/reimbursement agencies.
- Minimum 5 years post PhD, 7 years post Master's degree or 10 years post Bachelor's degree of combined pharmaceutical industry and/or academic experience in PRO research.
- Strong knowledge of methodological approaches and technical aspects (study design, data analysis and interpretation) of COA development, validation, electronic migration and interpretation into clinical trial and observational studies.
- Able to develop strong internal relationships with cross-functional teams.
- Ability to understand, interact and responds to multiple internal and external customers.
- A track record of COA-related scientific presentations and publications.
Preferred Experience and Skills:
- Understanding of current and evolving PRO/COA measure requirements for regulatory labeling claims (e.g. FDA and EMA) and HTA/reimbursement (e.g. NICE and IQWIG).
- Strong project management skills.
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