Title: Senior Clinical Scientist
Location: Plainsboro, NJ
Type: Contract
Start Date: ASAP
Leading Pharmaceutical Company located in NJ is hiring a Senior Clinical Scientist w/ 6+ years industry experience. If you want to be a part of this groundbreaking work, please apply!
The Senior Clinical Research Scientist (Sr. CRS) will support the Clinical Strategy Department, contributing to the development and execution of global clinical trials. This role will work in partnership with the Medical Director and other cross-functional teams, ensuring high-quality and timely clinical deliverables.
Responsibilities:
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Lead or co-lead one or more clinical trials in various phases of development, ensuring implementation aligns with global development strategy.
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Assist in the creation and execution of Clinical Development Plans (CDPs).
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Contribute to the drafting of protocols, informed consent forms, Investigator Brochures (IBs), safety updates, study reports, and regulatory submissions.
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Support data management processes, including case report form (CRF) development and data review.
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Lead development of Medical Data Review Plans (MDRPs) and perform ongoing review of clinical data for safety and efficacy.
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Provide scientific input on country and site selection, feasibility assessments, and Key Opinion Leader (KOL) engagement.
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Coordinate and present at committee meetings (Dose Escalation, DMC, Steering, Safety).
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Partner with internal teams and CROs to ensure study plan alignment.
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Contribute to publications and prepare materials for investigator meetings, training, and site initiation visits (SIVs).
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Mentor junior Clinical Research Scientists as needed.
Qualifications:
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PhD, PharmD, MS, or equivalent in medical, biological, or pharmaceutical sciences.
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Minimum of 6+ years in clinical research, with 3+ years in drug development (oncology/hematology preferred).
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Experience working in a cross-functional, matrixed environment.