Merck Principal Scientist, (Director) - Epidemiology in Upper Gwynedd, Pennsylvania

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.

Under the general direction of an Executive Director, Epidemiology, the Principal Scientist, Epidemiology, has responsibility for the design, placement, conduct, analysis, and reporting of pharmacoepidemiologic research studies on assigned Merck products and for providing consultation on epidemiologic issues, as needed.

Primary activities include but are not limited to:

  • Has overall responsibility for worldwide pharmacoepidemiologic planning and study recommendations for assigned Merck products. The Pharmacoepidemiology Department supports all drugs, vaccines, and biologics in all therapeutic areas. Although staff are expected to develop primary subject matter expertise in one or more therapeutic areas, staff may receive assignments in any therapeutic area depending on need. The lead epidemiologist for this position will mainly supports assets in the Cardiovascular, Respiratory, and Immunology Therapy Areas.

  • Has lead responsibility for interaction with risk management sub - teams, value evidence sub - teams, clinical / regulatory sub - teams, and other areas of Merck Research Laboratories on epidemiologic matters related to product safety and risk management, post-marketing safety studies, regulatory activities, clinical study design and endpoint qualification/standardization/training for clinical trials.

  • Has lead responsibility for communication and agreement with regulatory agencies around the world, e.g., the U.S. Food and Drug Administration (FDA) and the Pharmacovigilance and Risk Assessment Committee (PRAC) of the European Medicines Agency on the design of non-interventional post-marketing commitments. Responsible for epidemiology content of regulatory response documents and advisory committee meetings.

  • Has responsibility for the design, conduct, and analysis of epidemiologic research studies on assigned Merck products worldwide in compliance with standard operational procedures.

  • Responsible for participating in inspection audits related to non - interventional studies.

  • Provides scientific oversight and mentorship to more junior Epidemiology staff, as needed.

  • Present epidemiologic research plans or results to internal review and governance committees; to external agencies such as FDA (including advisory committees), CDC, and AHRQ; and at scientific conferences, as needed.

  • Maintains close working relationships with colleagues in Clinical Safety and Risk Management, Clinical Research, Regulatory, Outcomes Research, Health Economics and Commercial. Assists them in areas where knowledge of epidemiology is relevant.

  • Contributes to Merck's prestige by maintaining recognition as an expert in his/her field; may publish independent scientific research in leading journals, participate in and present at scientific organizations and meetings, and serve as a peer reviewer for scientific journals.

  • May hold academic appointments, teach graduate courses, and supervise Ph.D. dissertations and post doctoral fellows.

Education Minimum Requirement:

  • Ph.D in Epidemiology or M.D. with additional research training in epidemiology and at least 5 years of relevant work experience. Alternatively Master’s Degree in epidemiology with at least 7 years relevant work experience.

Required Experience and Skills:

  • Substantial experience in the successful direction of large epidemiologic projects; broad knowledge and experience in the application of epidemiologic approaches to problems in the pharmaceutical or biotechnology industry; and record of research publications in peer-reviewed journals. Creative problem - solving ability and excellent communication skills (oral and written) are expected.

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Job Epidemiology

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Other Locations: NA-US-NJ-Rahway

Title: Principal Scientist, (Director) - Epidemiology

Primary Location: NA-US-PA-Upper Gwynedd

Requisition ID: EPI000273