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.
Sr. Clinical Scientist, role and responsibilities:
•Accountable for the successful leadership, comprehensive clinical and operational planning/feasibility, and execution of a clinical trial.
•Leads and directs team in key study planning, development and execution elements (e.g., data management deliverables, protocol level plans/timelines, country/site selection, system updates, Investigator Meeting planning and presentations, communication plans, risk identification and mitigation, issue resolution safety and medical monitoring, preparation of status update reports, study closeout activities).
•Facilitates and collaborates with key internal/external stakeholders (trial team, subsidiary country teams, vendors, committees, etc) in support of clinical trial objectives.
•Accountable for managing any trial specific partners and/or vendors.
•Responsible for authoring of clinical protocols, clinical study reports, regulatory agency update reports, responses to regulatory agencies, and other clinical and regulatory documents.
•Contributes to the authoring of CTD/WMA subsections.
•Supports Clinical Directors in scientific leadership/investigator initiatives including preparation of publications, meeting presentations, etc.
• BS/BA degree with a minimum of 11 years of experience in clinical drug development, pharmaceutical industry or in the healthcare field (a minimum of 7 years of experience for Bachelor's Degree in Life Sciences); OR a Master's degree with a minimum of 8 years in clinical drug development, pharmaceutical industry or in the healthcare field (a minimum of 5 years of experience for Master's Degree in Life Sciences); OR a PhD with a minimum of 2 years in clinical drug development, pharmaceutical industry or in the healthcare field (no experience required for PhD in Life Sciences)
• Understanding scientific process, as well as medical and statistical concepts
• Understanding of all aspects of clinical development form program planning to regulatory submission
• Ability to contribute and collaborate with a team including proactive issue identification and resolution
• Must be able to make independent, timely, data-driven and appropriate decisions
• Must have excellent oral (including presentation) and written communication, and computer/database management skills
• Demonstrated project management skills with proven ability to lead cross-functional team and individuals
• Ability to influence and collaborate internally as well as externally with partners and study-related vendors
• Minimum of (3) years' experience in the Pharmaceutical industry
• Oncology Therapeutic area experience within the Pharmaceutical industry
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 firstname.lastname@example.org.
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.