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Job Title

Senior Clinical Scientist

Company : Gables Search Group

Location : Bridgewater, NJ

Created : 2021-12-18

Job Type : Full Time

Job Description

Global Pharmaceutical Leader in Dermatology and other biologics- looking to hire a Snr Clinical Scientist The Senior Clinical Scientist participates in creating the clinical strategy, design of clinical trials, creating documents supporting the scientific aspects of the clinical study and contributing to the clinical study report. Responsibilities Organizes, assists with, manages, and conducts Scientific Advisory Boards and KOL reviews Develops, researches and maintains current and future competitive clinical landscape(s) Identifies clinical thought leaders within the appropriate therapeutic area to establish relationships and provide scientific outreach within the dermatological specialty community Coordinate study design and Protocol development with team members to address scientific questions Owns scientific aspect/rationale of the protocol (i.e. methods, scales, labs, etc.) and contributes to clinical section of development plan and/or protocol(s) in collaboration with other clinical study team members Coordinates with team members to address scientific questions related to planned or ongoing clinical trials, in liaison with relevant staff at CRO(s) and vendors as applicable Contributes to the selection of vendors, countries and trial investigators Supports the development of the Clinical Study Report (CSR), in collaboration with the scientific writer or others Contributes to the preparation of regulatory documentation (Briefing Packages, Investigator's brochures, IND/IMPD, labelling documents etc.), and answers to questions from Health Authorities during the review process etc. Prepares and reviews SOPs, and contributes to process improvement initiatives, as deemed appropriate Requirements Bachelor's degree in Life Sciences, Engineering or related field, required. Master's degree, PhD or Medical Doctor, preferred. Seven (7) or more years of relevant experience in clinical research and development in the pharmaceutical industry and/or in a Contract Research Organization (CRO), is required. Experience in the scientific aspects of design and conduct of large and/or complex phase 2/3 clinical trials is preferred. Fluency with GCP and ICH guidelines required Experience in supporting development of systemic agents (large or small molecules) required Experience in presenting to a scientific audience Proficient in MS Office applications Fluent in English (written and oral) Good knowledge in MS Office applications Where permitted by applicable law, successful applicants must be fully vaccinated against COVID-19 by their date of hire to be considered for employment. Proof of vaccination required.