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Job #02628

About our client Our client is a private, clinical-stage company based in the Northeast, developing peptide mimetic of native growth factors for use in advanced bone repair. The company has 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 Operations Northeast, USA Salary Reports to Highly competitive package, commensurate with experience Vice-President of Product Development Responsibilities 1) Participate in developing global clinical plans 2) Provide strategic and tactical advice to the Executive Team regarding feasibility of clinical study designs, implementation, timelines and cost of clinical trials 3) Develop and write protocols 4) Implement plans and study-related tools/reports 5) Participate in discussions with regulatory authorities 6) Build and lead a Clinical Team and the infrastructure needed to support it 7) Review and write departmental SOPs and training guidelines 8) Oversee data management functions 9) Select and manage CROs 10) Coordinate vendor audits, RFPs, negotiations and selection 11) Select and, if need be, manage IDMCs 12) Create and lead cross-functional clinical project teams 13) Set up the selection, initiation, monitoring and close-out of investigational sites 14) Review, evaluate and interpret all clinical data and make recommendations to the team as needed 15) Coordinate data clean up 16) Interact with and manage all internal and external groups participating in a clinical project 17) Coordinate investigator meetings 18) Prepare and deliver presentations at various meetings 19) Participate in IDE, PMA and other regulatory submissions writing 20) Build, mentor, lead and support a Clinical Team (internal and/or external) based on corporate demands for resources 21) Develop and maintain clinical operations infrastructure 22) Provide strategic and tactical recommendations to the senior management regarding global clinical development programs implementation 23) Assess feasibility of proposals, develop project budgets and ensure on-time and on-budget progress of trials 24) Update the Executive Team on trials/sites progress, milestones, risks and solutions Requirements 1) B.S or BSN degree 2) Experience in orthopedics preferred 3) Minimum 15 years of broad experience in clinical research and development 4) Experience of working in small sponsor organizations 5) Strong team and project management experience, with at least 5 years of experience in it 6) Working knowledge of GCPs, ICH and CFRs 7) Knowledge of clinical development pertinent to medical devices 8) Proven leadership skills 9) Excellent communication (written and oral) skills 10) Willingness to travel – 10 – 30%