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Job #02570

About our client Our client acquires, develops, and commercializes innovative products for the treatment of infectious diseases such as HIV/AIDS, hepatitis and other associated infectious conditions. They bring to the table a strong management team with a wealth of knowledge in multiple therapeutic areas. Position Location Clinical Development Scientist New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Implement the strategy and late-stage drug development plans for relevant programs within the department 2) Ensure effective designing of protocols 3) Conduct clinical studies, both independently and in partnership with internal scientists and external consultants 4) Provide leadership in clinical development programs 5) Act as a member of the Senior Clinical Management Team 6) Handle strategy and operations of the late-stage programs 7) Develop clinical protocols, case report forms and summaries 8) Oversee preparation of clinical pharmacology sections of annual reports for Regulatory Affairs, FDA, etc. 9) Prepare investigator’s brochures and general investigational plans 10) Identify, contact and visit potential investigators 11) Oversee effective clinical research plans, clinical sections and regulatory strategy for INDs and NDAs to the FDA, EMEA and other health authorities around the world 12) Represent the Clinical Development Team (as necessary) with internal and external groups 13) Function as an expert liaison between the company and leading academic specialists 14) Manage appropriate CRO regarding supervision of clinical trials Requirements 1) M. D., Ph. D or Pharm. D 2) 6 – 10 years of industry experience in general drug development 3) Experience in Phase II-III development, clinical operations and safety assessment 4) Experience in Phase I and IIA programs preferred 5) Experience in HIV preferred 6) Ability to represent the company at appropriate FDA meetings and medical conferences