Senior Director of Clinical Operations

Bay Area pharmaceutical company is seeking a Senior Director of Clinical Operations to assist with the strategic management and facilitation of this group's clinical trials. Qualifications * 10+ years in the pharmaceutical/biotech industry or relevant clinical research organization * Prior management/supervisory experience as Department Head * Experience building clinical operations groups and associated infrastructure * Demonstrated project management/clinical operations experience and leadership skills (e.g., managing cross functional study teams, managing outside collaborators) * BA/BS/MS in scientific discipline, MPH, PharmD, PhD and/or RN license * Strong communication skills (verbal and written) * Must have significant regulatory experience spanning Phase I-IV trials, preferring past participation in an NDA or BLA process. * Intense drive and organizational expertise are necessary to manage the diverse group of functional activities involved in the international clinical trials program. * Proficiency in CFR, GCP/ICH and regulatory issues * Must have significant experience managing global Phase I-IV trials, including trials in Europe under the European Clinical Trials Directive, CRO management, direct CRA management, and project and contract management. * Hands-on ability to think strategically and tactically * Knowledge and experience with managing contracts (vendor and site) and interface with finance group * Proficiency in independently developing budgets and overseeing expenditures * Experienced with authoring of Clinical protocols; sections of the IB; sections of the IND; final study reports and Clinical sections of NDAs or BLAs * Excellent interpersonal skills This is a permanent, full time, in house, position located in the Bay Area. All interested parties should apply with a copy of their updated resume in word format.

To find out more about Real please visit www.realstaffing.com [1]

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[1] http://www.realstaffing.com