Associate Director, Clinical Operations

Job Advertised by Pharmadiversity Job Board - * Participate in strategic planning activities and translate strategic decisions into operational plans. * Work with CPMs and senior management to develop and implement project hiring plans to ensure efficient and cost-effective trial management. * Direct all aspects of global and domestic clinical trials to ensure delivery of company goals on time, within budget, and in compliance with SOPs and FDA and ICH/GCP guidelines. * Management of Clinical Operations staff with direct reports including both internal and external staff. * Responsible for hiring, retention, coaching, and performance appraisals of the staff. * Identify training needs and develop training plans for direct reports, including on-going training for current employees and training for new employees/consultants as appropriate. * Assist senior management in the development of resource projections for projects. * Contribute to building the clinical infrastructure within Cerexa, Inc., including policies, procedures, guidelines, cross-functional communication, and interaction plans. * Direct the development, review, and finalization of SOPs to ensure continued compliance with applicable FDA/GCP/ICH guidelines. * Work closely with Regulatory Affairs in the preparation and support of regulatory filings. * Participate and support as needed clinical study report writing and protocol preparation. * Contribute to the development and management of the clinical operations budget and relevant components of the department budget. * Provide senior management with necessary updates on progress and changes in scope, schedule, and resources in a timely manner. * Review and approve clinical contracts. * Direct clinical program timelines. * Provide oversight and assist in the formulation of the outsourcing review process at Cerexa, Inc.; oversee the qualification and selection of various vendors as well as the preparation of proposal requests. * Identify and implement methods for improving communications/sharing ideas across departments and project team. Assist with resolution of cross-departmental issues. * Provide Clinical Operations input into clinical portion of INDs, NDAs, and interim/annual/final reports. * Bachelor's degree; advanced degree in the discipline of life sciences (MS/PhD/RN/BSN) a plus. * Ten or more years of experience in the management of clinical operations function and staff in a pharmaceutical and/or biotechnology environment; the final job title will be commensurate with the candidate's experience. * Demonstrated proficiency in the implementation, monitoring, and management of global and domestic clinical trials, CROs, timelines, and budgets; experience in Phase I, II, and III (including regulatory processes and contract hurdles). * Management of the life cycle of multiple global clinical studies highly desired. * Participation in a clinical trial program through NDA a plus. * Experience with strategically developing, implementing, and.... br/ br/ * For application attention if web source is requested please use PharmaDiversity or PharmaDiversity Job Board. br/ br/ APPLY FOR THIS JOB by going to ...http://www.pharmadiversityjobboard.com/view_job.php?post_id=502480&tag=aje