Associate Director Clinical Operations - Oncology

Associate Director, Clinical Operations – Oncology Our client is an elite and profitable biotechnology company.  They have asked us to assist them in their search for an Associate Director, Clinical Operations – Oncology.  Responsibilities for this position will include, but are not limited to, the following:   Overall strategic management for the planning, execution and reporting of multiple clinical programs (phases I – III) needed to support INDs, SNDAs, NDAs with focus on execution, administration and organization. Draft protocols in cooperation with medical staff and statistics group. Set project goals, develop feasibility assessments to plan for accurate number qualified of investigators for study conduct to support clinical development plans. Oversee Clinical Operations Managers and assure adherence to high quality GCP standards for studies. Must participate directly in all study activities as necessary. Participate in drafting/review of integrated clinical study reports, annual reports, Investigator Brochure updates. Develop, track and administer budgets, FTE requirements, and schedules with responsibility for cost, time and quality of clinical operations activities. Must be able to anticipate deviations, and inform management with proposed corrective actions. Prepare RFPs, and participate in the identification, selection and oversight of Contract Research Organizations, central laboratories, IVRS vendors for outsourced programs. Participate on project and clinical teams serving as key liaison to project managers. Interface with all drug development personnel to ensure timelines are met, conflicts resolved and projects are on time and on budget. Provide guidance and expert advice in the areas of SOP development and clinical research regulations Train and mentor subordinates to assure project requirements are met and for staff growth and developmentWe seek candidates who possess an advanced degree (or equivalent experience) in a relevant scientific discipline, with a minimum of 7-12 years of clinical operations and clinical research management experience. Additional required skills and knowledge include:· Demonstrated management skills and experience, with success in executing clinical research projects · Excellent written and verbal communication skills and interpersonal skills. Must be able to relate effectively to people at all levels of the organization. · Computer literate; familiarity with Microsoft Office programs, in particular, Microsoft Project (or similar planning/tracking software). · Clinical project management skills · Knowledge of clinical trial design, basic statistics and pharmacokinetics will be considered a plus· Familiarity with all other aspects of the drug development will be considered a plus Do you have the experience we seek and want to advance your career with an industry leader?  If so, please email your resume as a Word attachment to kim@jobsrecruiting.com , Reference # 2131-M.  No calls or faxes, please.  Include your daytime phone number and we will contact you confidentially. Fairway Consulting Group is a leading executive search firm dedicated to the pharmaceutical and biotech industries.  www.fairwayconsultinggroup.com  or www.jobsrecruiting.com MRINetwork is the largest and most successful search organization in the world. Each MRINetwork office is a single point of contact to over 1,100 offices in more than 37 countries, our candidates have access to the right jobs virtually anywhere in the world. LOCATION: US-NJ-Central JOB CATEGORY: Biotech/R&D/Science TYPE: Full Time, Employee JOB REFCODE: 2131-M COMPANY: Fairway Consulting Group ADDRESS: 300 Merrick Road - Suite 404Lynbrook,NY 11563 PHONE: 516 596-2800 EMAIL: Apply by Email