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. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Principal Scientist, Clinical Research:
- Designs and provides oversight of clinical research programs.
- Builds relationships with key opinion leaders and applies their input to enhance study design and protocols.
- Ensures that clinical research program design meets scientific objectives and is aligned with commercial needs.
- Serves as a medical/scientific consultant to marketing or research project teams and government regulatory agencies.
- Establishes the conditions essential for determining the safety, efficacy, medical usefulness, and marketability of drug or medical device products candidates.
- Interprets results of Phase I-IV investigations in preparation for new-drug or medical device application.
- May serve as safety expert for individual clinical projects.
Some responsibilities include:
- Responsible for clinical research protocol development and medical/scientific oversight of clinical trials (Phases 2-4) involving experimental or marketed drugs in the infectious disease clinical research group.
- Participates in all phases of clinical development process for Merck Research Laboratories sponsored studies including study design, medical monitoring and medical/scientific interpretation of study analyses for both efficacy and safety non-study safety reports and scientific and regulatory document authoring.
- Apply an in-depth understanding of the disease under study and provide input to the development and implementation of short and long-term objectives of the infectious disease clinical research group.
- Provide internal scientific leadership for cross functional areas supporting clinical development and external leadership through interaction with study investigators.
- Infectious disease/HIV background and/or experience in clinical trials of infectious disease drugs (preferably HIV).
- Excellent communication and writing skills.
- Demonstrated ability to work as part of a high performing team.
- Demonstrated leadership skills with ability to work in a high performance teams and/or matrix organization.
- Pharmaceutical Industry experience.
- Experience conducting industry sponsored drug development trials.
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at email@example.com. Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
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