Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
Under the general direction of the Patient-Centered Endpoints & Strategy (PaCES) group lead, the Associate Principal Scientist has responsibility for coordinating global Clinical Outcomes Assessment (COA) endpoint strategies, including Patient-Reported Outcomes (PROs) for specific disease areas. The individual will support 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 Associate Principal Scientist will work closely with individuals from all Center for Observational and Real-World Evidence (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:
Coordinate global COA/PRO strategic plans in support of Early Development Teams (EDTs), Value Evidence Sub-teams (VESTs) and Clinical Sub-teams (CST) to assure alignment with product franchise goals
Provide assistance on the selection and/or development of COA/PROs for inclusion in studies
Provide guidance on implementing COA/PROs into studies by following our Company's standard processes
Facilitate alignment of the selection of an appropriate endpoint measure to satisfy both regulatory and reimbursement agencies
Coordinate COA/PRO related sections of evidence packages to be submitted to regulatory and reimbursement agencies
Coordinate the development, validation, implementation, and utilization of instruments aimed at measuring COA/PROs in the context of clinical trials and/or observational studies
Support literature searches to support COA/PRO endpoint strategies
Support/Produce scientific communications (abstracts, poster presentations, podium presentations, manuscripts, etc.)
Keep up to date with COA/PRO methodologies and guidelines (including those from Regulatory Authorities) and communicate findings to cross-functional teams as needed
Required: Bachelor’s Degree in Health Services Research, Statistics, Psychometrics, Outcomes Research or closely related field
Preferred: Master’s Degree in Health Services Research, Statistics, Psychometrics, Outcomes Research or closely related field
Familiar with PRO requirements for regulatory and HTA/reimbursement agencies
At least 5 years of pharmaceutical industry and/or academic experience in COA/PRO research with at least 3 years in the pharmaceutical industry
Knowledge of methodological approaches and technical aspects (study design, data analysis and interpretation) of COA/PRO development, validation, electronic migration and interpretation into clinical trial and observational studies
Ability to understand and respond to multiple internal and external customers
Strong project management and communication skills
Experience with COA/PRO-related scientific presentations and publications
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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.
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