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Job #03156

About our client Our client develops biopharmaceutical treatments for infectious diseases. Drugs in its pipeline include antiviral treatments and antibacterial treatments. The company has premier investors, an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Director of Clinical Development East Coast, USA Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee clinical and non-clinical trials across various therapeutic areas 2) Coordinate multiple studies with CROs 3) Manage all aspects of studies including clinical and non-clinical investigational sites that are not delegated to CROs 4) Work with medical monitors, CROs and investigational site personnel to assure adequate regulatory guideline compliance 5) Coordinate interaction between Regulatory Affairs and Clinical Development to maintain regulatory files for IND submissions, IND annual reports and safety assessments 6) Undertake project management/coordination of all clinical work product, spanning preclinical development and regulatory areas 7) Manage all aspects of site visits, including site assessment, regulatory document collection, site initiation, patient data monitoring, drug accountability and site closeout 8) Maintain contact with CROs and sites to ensure adequate regulatory compliance 9) Prepare timely reports and updates for ongoing trials 10) Present data/updates to peers/supervisors as well as in meetings outside the company 11) Manage project tasks covering multiple and/or large-scale projects (strategic planning, timeline development and setting deadlines, assignment of project related duties, monitoring project status and providing direction to lower-level associates) 12) Develop and maintain strategic relationships with third party vendors, organizations and key opinion leaders 13) Assist in preparation of regulatory submissions (INDs, IND annual reports, safety updates, NDAs, CTDs) and investigator brochures 14) Handle protocol writing and their updates 15) Perform other duties as assigned Requirements 1) BS/MS in a relevant scientific field 2) Minimum 6 – 8 years of related experience in clinical research or related field (Regulatory Affairs, Quality Assurance or Nursing) 3) Knowledge of infectious disease and infectious disease treatments a plus 4) Willingness to travel (up to 10% – 15%)