Description
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