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.
Upper Gwynedd, PA Job #EPI000276
Under the general direction of the Executive Director, Epidemiology, the Director, Epidemiology has lead management and oversight responsibility for pharmacoepidemiologic activities conducted by epidemiologists of his/her team on assigned Merck products, and provides broad leadership and direction on scientific and operational aspects of epidemiologic research. The primary focus of this position is vaccines and infectious diseases (ID).
Key responsibilities include and are not limited to the following: - Has overall responsibility for the management and scientific oversight of a small team of pharmacoepidemiologists in one or two therapeutic areas (TA). Provides guidance to team members on worldwide planning, design and execution of pharmacoepidemiologic studies and activities related to product safety and risk management, post-marketing safety and effectiveness studies, regulatory activities, clinical study design, efficacy and safety endpoint qualification/standardization for clinical trials, biomarkers/molecular epidemiology/genetic epidemiology, value evidence, and studies of the natural history of disease for assigned Merck products in team. Supervised by TA Executive Director, Epidemiology. - Reviews regulatory documents, reports and publications within assigned products in TA to assure scientific integrity and alignment with Merck strategies and plans. - Makes key epidemiologic decisions and is accountable for deliverables (strategies, plans, timelines, and reports) and for study budgets for her team. Executes independently. - In addition to team oversight responsibility, has product - level responsibilities for one or more products. - Presents epidemiologic research plans and results to internal review and governance committees. Participates in interactions with regulatory agencies and health authorities such as FDA, EMA, CDC, Ministries of Health, and WHO. - Has expert level of epidemiologic, regulatory, and leadership skills to set epidemiology strategy for products. Has proven record of serving as the lead in planning, conducting, analyzing, and reporting epidemiologic of studies. Problem solving involves product development strategy, regulatory strategy, scientific interpretation of results, and solving operational issues. Problem solving may also involve personnel matters and cross-functional/cross-divisional matters. - Has expert skills in people management, mentoring, collaboration, teamwork, multitasking, and communication. Responsible for performance management, employee development, and coaching / mentorship. - 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 participate in external strategic initiatives (e.g., DIA, PhRMA, consortia) that are of critical importance to Merck. May hold academic appointments, teach graduate courses, and supervise Ph.D. dissertations and post-doctoral fellows. - Direct reports: 2 to 4
Education Minimum Requirement: - Required: MS in Epidemiology with (8) years of relevant work experience - Preferred: Ph.D in Epidemiology or MD (or equivalent) with additional research training
Required Experience and Skills: - Minimum of (7) years of relevant work experience - Extensive 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) - At least 2 years of management experience - 5% Travel
Preferred Experience and Skills: - Background in Infectious Diseases (ID) and Vaccines and experience in conducting ID and / or vaccine epidemiologic studies and activities are preferred for this position.
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