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Job #02511

About our client Our client is a publicly traded biopharmaceutical company headquartered in Washington that is dedicated to the development and commercialization of antibody-based therapeutics for the treatment of cancer. 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 Associate Director of Clinical Trial Management Washington Salary Highly competitive package, commensurate with experience Responsibilities 1) Execute clinical development program from protocol designing to the final clinical study report for one or several studies 2) Manage the process and people involved either as direct reports or though matrix reporting via the clinical indication team 3) Coordinate all efforts for the trial both within the company and through a wide variety of vendors 4) Assume leadership responsibility within the Clinical Project Management Group 5) Work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors 6) Manage larger, complex trials with multiple vendors and solves issues across functional areas 7) Assume responsibility for some or all of the project management infrastructure, training and representation of the group 8) Ensure budgets, schedules and performance requirements across multiple compounds are met 9) Drive the development of project management processes and best practices 10) Take a leadership position in departmental development 11) Act as an advisor to subordinates to meet schedule and or resolve technical problems 12) Interact with senior management or executive-levels on matters concerning several functional areas, divisions and/or customers 13) Change the thinking of or gain acceptance of others in sensitive situations 14) Interact/involve in matters between functional areas other company division or units (e.g. Finance, Legal, Manufacturing, Marketing) Requirements 1) Bachelor’s degree with at least 10 years of pharmaceutical clinical development experience or equivalent 2) Advanced degree (master’s or Ph. D), oncology/hematology clinical trial experience 3) NDA filing experience, international clinical development experience and/or 12+ years of applicable experience preferred 4) Project Management Certification (PMP) preferred 5) 10+ years of clinical experience 6) Minimum 5 years of experience as a CRA and 2 years of experience as Senior Trial Manager/Assistant Director 7) Experience in Phase I-IV trials, CRO management and project and contract management 8) Oncology or hematology experience preferred 9) Experience in managing projects and demonstrated leadership capability 10) Experience in managing a group of CRAs and as well as hiring/terminating staff 11) Experience in managing trials outside USA (at least the CRA portion) 12) Experience in managing trials in Europe under the EU Clinical Trials Directive 13) Demonstrated ability to manage and coordinate senior-level scientific management personnel and to resolve project issues across organizations 14) Demonstrated ability in planning skills 15) Ability to identify risks and anticipate various outcomes, balance short-term and long range objectives 16) Ability to apply project management disciplines, including adherence to corporate financial plans and operating strategies 17) Demonstrated ability to think and act strategically, tactically and operationally 18) Ability to direct actions of project team personnel 19) Excellent communication, leadership, conflict resolution, risk management, delegation, decision-making and documentation skills 20) Willingness to travel