PRINCIPAL SCIENTIST, PROS (PATIENT-REPORTED OUTCOMES)
Merck Sharpe & Dohme Corp
May 14, 2018
Upper Gwynedd, Pennsylvania
Full Time - Experienced
Academic / Research
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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world's premier, most research-intensive biopharmaceutical company. Today, we're doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck's leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
PRINCIPAL SCIENTIST, PROS (PATIENT-REPORTED OUTCOMES)
Upper Gwynedd, PA
Job # EPI000268
Under the general direction of the Patient-Centered Endpoints & Strategy (PaCES) 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, analysis and interpretation of COA endpoints 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 including;
Coordinate and lead the development, validation, analysis, 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
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, or Master's in Health 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 or 7+ years post Master'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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