Associate Director of Clinical Operations - Pharmaceutical Clinical Associates, LLC

Position Description

The selected candidate will effectively manage the operational activities of staff within Clinical Operations in a productive and proactive manner that ensures all timeframes and study targets are met with high quality and that costs are effectively managed. Coordinate the overall management, development and direction of assigned clinical projects and studies, whether performed by staff or through CROs, in accordance with FDA and ICH good clinical practice (GCP) guidelines, federal regulations and within defined budgeting and time limits. Assess and allocate resources for assigned studies and provide resource utilization data on a regular basis. Assist in departmental fiscal workload projections. Lead and direct departmental planning and coordination of study set-up, execution, training materials and guidelines and other project-related and/or department-related duties. Recommends and implements innovative process ideas and solutions to impact clinical trials management.
Reporting to the Vice President of Clinical Operations, the Assistant Director, Clinical Operations will have broad responsibilities for the conduct of clinical studies for investigational products. These responsibilities will include, but are not limited to: Provide high-quality leadership, knowledge, and training to the clinical operations staff thus, securing the successful completion of clinical studies, from the successful enrollment of evaluable patients to the delivery of clean data, while achieving optimal project parameters of time, quality and cost. Assist the Vice President of Clinical Operations in aligning the departmental goals and needs with study objectives, ensuring the effective management of studies meeting timelines and expectations, and in adherence with SOPs, GCPs, appropriate regulations and high quality standards. Serve as Study Team Leader for projects as assigned. Assess the qualifications and capabilities of potential vendors, including CROs and investigators, and provide recommendations to management about appropriate service providers to initiate and expedite the conduct of clinical studies. Manage vendors as necessary to achieve company objectives. Review and /or prepare Clinical Monitoring and Site Management Plans, including actions for study start-up, recruitment, monitoring and quality data deliverables. Provide support for regulatory activities, such as IND Annual Reports, and BLA submission materials related to assigned projects. Report on performance metrics related to quality, cycle times, cost and potential process improvements. Contributes to and maintains standards within Clinical Operations (templates, SOPs, best practices). Conduct other projects as requested.



Bachelor’s Degree required (health science major preferred); advanced degree preferred. Requires minimum 8 years clinical research experience in pharmaceutical/ biotechnology industry (oncology experience preferred), knowledge of FDA/ICH regulations/guidelines regarding Good Clinical Practices. Must be proficient in MS Word and Excel, familiar with PowerPoint; knowledge of MS Project desirable.
Must be able to proactively recognize study and / or company needs and implement an effective action plan, oversee all aspects of study management, manage study managers and interact positively with all levels of staff, liaise successfully with all levels of management at vendors, including CROs to which significant operational responsibilities have been delegated, and partners. Must be able and willing to travel approx. 20% of the time (International and Domestic). Must be organized, efficient in managing multiple high priority tasks, and a decision maker with strong interpersonal, communication and collaboration skills. Must have the ability to effectively formulate strategies, develop sound contingency plans and apply tactics and action plans to achieve desired results. Demonstrated prior supervisory experience is required.

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