Partner Companies

Merck

Merck Website
2000 Galloping Hill Road, Kenilworth, NJ 07033

Fellowship Duration

2 years

Fellowship Positions Available

Clinical Safety and Risk Management (Pharmacovigilance)

Global Medical Affairs: Oncology

Global Regulatory Affairs

Late Stage Clinical Development: Oncology

Translational Pharmacology

US Medical Affairs

Company Information

At Merck we are committed to improving health and wellbeing around the world.  Merck’s core values are driven by a desire to improve human life, achieve scientific excellence, operate with the highest standards of integrity, expand access to our products and employ a diverse workforce that values collaboration.

Merck Research Laboratories (MRL) and Global Human Health (GHH) have designed a two-year fellowship program that will offer fellows a tremendous opportunity to learn, grow, and be part of a dynamic and exciting culture. We believe the fellowships offer a unique opportunity to build skills and gain hands-on experience that will be invaluable in pursuing a career in the dynamic and fast-changing pharmaceutical industry.

Translational Pharmacology

The Early Clinical Scientist (ECS) fellow will be part of Translational Medicine Clinical Operations (TMCO) and will support the department of Translational Pharmacology (TPharm) . The mission of TPharm is to discover novel targets and biomarkers to initiate new programs, conduct early clinical development trials to test therapeutic hypothesis and to support late development programs through filing and approval  The fellow will be responsible for developing protocols, creating case report forms for data collection, initiating studies, data monitoring, data clean-up, and reporting of studies. The focus of the investigations will be geared toward the understanding of new molecular entity (NME) safety and tolerability in healthy subjects and patients, mechanism of action pharmacokinetics, pharmacodynamics, as well as proof of concept.

Late Stage Development – Oncology and Primary Care (including Diabetes, Respiratory & Immunology) 

Clinical Sciences & Study Management (CSSM) is a sub-functional unit within GCTO accountable for all operational, technical and scientific aspects of headquarters-sponsored clinical trials, including local registration trials and regulatory commitments. The Clinical Scientist (CS)/Study Manager (SM) fellow will support the scientific aspects of late stage clinical development within therapeutic areas of oncology, diabetes, or respiratory & immunology, as well as play a key role in the operational planning and execution activities for our LSD clinical studies. Through involvement and interaction with other functional areas, the fellow will become familiar with patient recruitment, patient retention, protocol design, scientific and operational oversight of trials, and more while collaborating with other functional areas.

Clinical Safety & Risk Management

As a member of the Clinical Safety & Risk Management (CSRM) department within Global Regulatory Affairs & Clinical Safety, the CSRM fellow will develop expertise in the overall clinical risk management and safety surveillance of assigned marketed products. She or he will learn about all aspects of safety surveillance, including assessing safety information, safety signaling and data mining, and ensuring completeness of safety information in worldwide package circulars. Additionally, she or he will have joint responsibility for the development of periodic safety update reports and risk management plans while collaborating with other departments across the Company.

Global Medical Affairs

The Global Medical Affairs (GMA) fellows will have broad experiences across the organization while focusing on Oncology.  They will gain experience within 1.) Global Medical Information (learning about: unsolicited Professional Information Requests (PIRs), medical review of promotional materials for marketed Oncology products, development and delivery of training materials, and launch activities around the globe)  and 2) Oncology Global Medical Affairs (focusing on  Scientific Leader engagements, Oncology Medical Affairs Strategy and associated content creation, Oncology Global Medical Affairs Plans and operational projects that directly support  the organization. .

US Medical Affairs

USMA partners with internal and external stakeholders to communicate relevant information that enables appropriate, accurate and timely access to relevant Merck science and therapies.   USMA Fellows will gain broad Medical Affairs experience by rotating through functions in the USMA organization that include those noted below and across a broad range of therapeutic areas including cardiovascular and metabolic, infectious disease, surgery/anesthesia, neuroscience, virology, oncology and vaccines:

  • Field Medical:  Engage in scientific and medical discussions with scientific leaders (Healthcare providers) and key decision makers. 
  • Therapeutic and Customer Segment Strategy: Participate in the input gathering and strategic decision process to support the development of appropriate medical affairs strategies. 
  • Content and Training: Create medical and scientific content to enable external engagement with scientific leaders and key decision makers. The Fellow will take new content through the process of development, review & approval, and training & implementation. 
  • Strategy & Operations: Execute cross-functional projects required to achieve USMA organizational objectives. 
  • Advocacy and Professional Affairs: Engage with professional organizations and attend conferences that are supported by Merck through the APA processes. 

Global Regulatory Affairs

The Global Regulatory Affairs fellowship  resides within Merck’s Global Regulatory Affairs and Clinical Safety (GRACS) group. The fellow will develop a skill set to develop regulatory strategy for early and late stage development products, , act as a member of cross-functional product development teams, prepare and file strategic regulatory dossiers and health agency correspondences, and learn how global regulatory affairs is incorporated throughout the organization.  As necessary, the fellow may interact with the U.S. FDA and international regulatory agencies to discuss and align on issues relating to development programs and/or responses to Health Authority questions. The fellow will also liaise with other Merck regulatory personnel around the world to ensure a global regulatory strategy regarding product development while incorporating needs of various countries.

Quantitative Pharmacology and Pharmacometrics

The Quantitative Pharmacology and Pharmacometrics (QP2) group is responsible for developing and executing PK/PD and Modeling & Simulation (M&S) strategies and applying functional area knowledge to frame critical drug development questions for optimizing model-based drug development as a member of cross-functional drug development teams.  The QP2 fellow will be responsible for developing expertise in PK/PD and M&S through efforts designed to support the antibacterial therapeutic area.  These efforts will focus on translational sciences designed to provide input on the design of in vitro and preclinical experiments, quantitatively analyze the resulting data, and integrate the results with PK and PD data from clinical studies.  Together, the results of these analyses will be publishable and will have direct impact on programs in Merck’s antibacterial portfolio, influencing dose selection, breakpoint determination, the influence of demographic factors on dose, the prediction of clinical efficacy, and other key decisions.

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