This job is a contract to hire full time. It is onsite in Princeton NJ. Must be a US citizen or Green Card Holder. Please do not apply if you are an H1 or OPT. Thank you
Job Description:
Contribute to the implementation of the global development strategy, leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in various stages of clinical development (e.g. clinical trial implementation), and oversight of all aspects of clinical development working closely with the Medical Director and other cross-functions to provide high-quality and timely deliverables - Contribute to the development of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP) - In collaboration with the Medical Director, contribute to the development of clinical and regulatory documents, annual safety updates, and registration dossiers (i.e., protocol, ICF, IB, annual safety updates, study reports, regulatory submissions) to support registration and commercialization of the compound(s) - Participate in the development of case report forms (eCRFs), eCRFs completion guidelines, and provide scientific support for other key data management deliverables (e.g. database lock activities) - Lead the development of the medical data review plan (MDRP), perform ongoing data review, and summarize efficacy and safety data for interpretation/analysis - Provide medical input for country/site selection, feasibility assessment and engage in KOL interaction -
Prepare charters and coordinate internal/external committee meetings including presentation preparation (i.e., Dose Escalation Committee, DMC, Steering Committee, and Safety Committees) - Participate in the development and review of study plans and serve as a liaison to project teams and CROs - Provide input for the development of publications in coordination with Scientific Communications - Prepare presentations for Investigator meetings, CRO/CRA training, SIVs as warranted - Mentor junior level Clinical Research Scientists as required
**Qualifications** - PhD, Pharm D, MS or equivalent degree preferably within the medical, biological, pharmaceutical science or related discipline - Minimum requirement: 6+ years of experience in clinical research with at least 3 or more years of drug development experience (preferably in oncology/hematology) - Experience working in a project-oriented matrixed team environment
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