Title: Senior Clinical Scientist
Location: Must be local to Princeton, NJ and work a hybrid schedule
Type: Perm
Start Date: ASAP
Leading Pharmaceutical Company located in NJ is hiring a Senior Clinical Scientist with 3+ years industry experience. If you want to be a part of this groundbreaking work, please apply!
Responsibilities:
- Develop and execute the scientific aspects of early clinical development studies and act as the primary clinical expert for clinical trial sites and study teams.
- Responsible for the clinical science planning of Phase 1 and 2 studies based on disease management using interviews with physicians and KOLs to obtain scientific and clinical information to support clinical development execution.
- Manage/author medical writing across program including Study Protocol (PRT), Investigator Brochure (IB), Clinical Study Report (CSR), IND clinical sections, amendments as well as responses to IRBs, Regulatory Authorities, and Ethics Committees.
- Review and analysis of study data, and interpretation, summarization and presentation of the study results.
- Seeking and collating scientific information, competitors’ information and expert opinion from KOLs in respective therapeutic areas to support drug development efforts.
- Assist in design of electronic case report forms (CRFs) and in review of informed consent forms (ICFs), statistical analysis plans (SAPs), and drug safety update reports (DSURs).
Minimum Requirements:
- Minimum 8 years clinical research experience in clinical development within pharmaceutical/biotech industry required, with at least 2 years doing first in human (FIH) studies (preferred).
- Experience in FIH studies as well as proof of concept studies, protocol development, data review, KOL engagement, data quality and safety and/or medical writing are strongly preferred.
- Experiences and knowledge in clinical development for drug in rare disease area are preferable.
- Previous experience working with clinical CROs and vendors.
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