We are currently seeking a Director of Clinical Operations who will report directly to the Chief Medical Officer (CMO). Successful candidates will be well versed in all aspects of clinical trial administration and have proven success managing trials throughout their career.
Knowledge of tasks and resources necessary to conduct a clinical trial
Excellent organizational skills to mobilize and deploy resources
Effective communication and ability to assign roles and responsibilities relevant to clinical trials
Attention to detail; ability to acquire and analyze information to troubleshoot problems
Excellent communication skills including oral and written
Team building: including the ability to reach consensus and delegate when necessary
Reasonable proficiency with computer skills to achieve goals including spreadsheet and document creation; creation and use of templates when appropriate
BA or BS degree, with advanced degrees a plus. Ten (10) or more years experience in the pharmaceutical industry: large company or biotech small company experience is relevant. Vaccine experience is highly desirable. The candidate should have proven success with:
Developing operations plans and managing Phase I-III clinical trials
Identification and selection of investigators and sites
Identification, selection and management of contract research organizations and other clinical trial support vendors
Working on multi-disciplinary drug development teams
The candidate should have excellent writing, organizational, and oral communications skills.
Oversee the clinical operations and execution of clinical studies: assure that resources are identified and in place for trial conduct.
Drive the process for CRO selection, and provide primary oversight for requests for proposals (RFPs), contract management.
Oversee the management of CROs and/or clinical sites from study initiation to close out, and ensuring adherence to all documentation requirements and process.
Set and manage clinical project timelines with the CMO and/or project manager to meet critical milestones; and/or escalate issues that may jeopardize timelines and deliverables.
Work with CMO and Finance to develop budgets, accruals and track the financial status against budget.
Oversee study logistics and monitoring activities, including patient recruitment, screening and enrollment.
Interact with active and potential clinical investigators.
Manage study monitoring visits, leveraging partnerships with CROs and regional monitors as necessary.
Organize and run meetings and teleconferences that assure smooth conduct of clinical studies.
Effectively communicate with other functional areas, such as Nonclinical, Manufacturing, and Regulatory Affairs in order to accurately coordinate clinical study activity.
Contribute to the writing or review of protocols, study-related documents, clinical study reports and clinical sections of the Investigators Brochure, INDs/CTAs and NDAs/MAAs.
Ensure compliance with FDA regulations, ICH guidelines for Good Clinical Practices (GCP) and the conduct of clinical trials.
Develop Standard Operating Procedures (SOPs) and study-specific guidelines as needed.
Hire, develop, lead and organize work and resources for clinical operations colleagues including, clinical trial assistants, clinical research associates, study managers, directors and independent contractors as necessary to achieve clinical development and corporate goals.
Other duties as assigned.
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