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Senior Principal Scientist, Outcomes Research West Point, PA
Under the general direction of the Patient-Reported Outcomes & Study Endpoints (PRO&SE) group lead, the Sr. Principal Scientist has responsibility for our Company's overall strategic direction on the use of Patient-Reported Outcomes (PROs) and additional Clinical Outcome Assessments (COAs) endpoints for regulatory submissions, reimbursement evidence dossiers, payer interactions, and publications. The individual has also responsibility for overseeing the implementation of this strategy thru appropriate inclusion and use of PRO/COA endpoints into clinical trials and Real World Data (RWD) across the portfolio. This role serves as the primary contact for interactions with global regulatory and reimbursement authorities related to PRO endpoints. The Sr. Principal Scientist will work closely with individuals from all CORE functions, Clinical Research, Regulatory Affairs, Biostatistics, and Operations to ensure PRO-related strategies are consistent with the product strategy and appropriately executed and interpreted to support marketing strategies.
Primary activities include but are not limited to:
Provide strategic direction to the Product Development Team (PDT) for the inclusion of PROs and additional COAs in studies to ensure successful label claims, reimbursement and publication for our Company's drugs and vaccines
Critically assesses drivers and barriers to PRO-related regulatory and reimbursement success and identifies value evidence needs to provide strategic input into clinical and market development programs. Bring strong PRO/COA regulatory, payer and HTA/reimbursement focus into the PDTs
Engage with Early Development Teams (EDTs) to understand the clinical development program, evaluate the need for and opportunity to develop new PROs/COAs measures to support product franchise goals
Work closely with the Leadership Team within CORE and Value Evidence Sub-teams (VESTs) to provide leadership in developing global PRO strategies and the to assure alignment of PRO/COA within our Company
Lead overall PRO/COA strategic direction and assume primary responsibility for PRO/COA endpoints across 2 of the 4 Product Lines
Develop or lead the creation of value evidence deliverables (e.g., evidence dossiers) for submission to regulatory or reimbursement agencies and represent our Company during these interactions
Lead cross-functional teams across several therapeutic areas to establish appropriate endpoint strategies for programs that include PROs and/or novel endpoints
Work closely with other departments to effectively develop/ communicate PRO and other key study endpoint findings/value evidence and support data and consistent messages throughout our Company and to external customers
Leverages other groups within and outside of CORE to develop and execute PRO/COA plans, including Product Line, Market Partners, Data Sciences and Insights, Pharmacoepidemiology, Portfolio & Operations, Office of Chief Medical Officer, Clinical Research, Regulatory Affairs and BARDS
Build relationships and work with external PRO experts to assure internal PRO strategies are in alignment with up-to-date scientific standards related to study design, protocols, measurement, analysis, and data interpretation
Communicate externally with regulatory agencies (e.g. FDA, EMA), reimbursement authorities, specialty societies, and special interest groups regarding overall strategy for the use and communication of PRO data
Presents PRO and COA data at international congresses and publish articles in scientific journals.
Doctoral or Master's Degree in Heath Services Research, Statistics, Psychometrics, Outcomes Research or closely related field
In-depth understanding and evolving PRO requirements for US and EU regulatory and HTA/reimbursement agencies
Minimum of 7+ years post PhD or 8+ 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 PRO/COA development, validation and implementations into clinical trial and observational studies
Demonstrated ability to develop strong external relationships with FDA and EU regulatory agencies and proven ability to address FDA and other external authorities
Ability to understand and respond to multiple internal and external customers
A track record of PRO-related scientific presentations and publications
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
We are an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.