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Assistant Director, Safety Management

North Chicago, Illinois

Post Date: 07/25/2017 Job ID: 1541 Job Category: Clinical: Clinical Operations and Development

Job Description:

This position will manage, lead and develop staff across therapeutic area team(s) within Safety Management, and to function as a resource within Safety Management, Clinical Teams, and the larger organization by effectively identifying staff and department needs that can help translate business vision into broad and actionable strategy.

Job Responsibilities:
  • Identify, initiate and implement process and workflow procedure improvements by monitoring and communicating workload projections and metrics for respective therapeutic areas and by participating in area budget process and proposals for assigned teams of healthcare professionals (approx. 5 to 40).
  • Function as a resource within Safety Management, Clinical Teams, and the larger organization with insight into industry trends and processes, and audit activities.
  • May assist in development of department training programs, ongoing knowledge attainment, and development of staff, by effectively identifying department and staff needs and successfully presenting them to management.
  • Assist management with strategic planning and development within Safety Management by facilitating incorporation of appropriate activities into therapeutic area teams activities and projects and demonstrating excellent interpersonal leadership, communication and development skills.
  • Ensures application of clinical SOPs reflecting evolving global regulations and processes related to clinical trials are implemented within assigned teams; and clinical SOPs are being followed within assigned teams.
  • Assists in the implementation of standardized clinical safety training and performance assessments by providing change leadership for technology and process improvements.
  • Routinely interact with Divisional Vice President for therapeutic area(s), Product Safety Team, and AD/Directors in multiple cross-functional areas (Regulatory Affairs, Pharmacovigilance, Data Management, Clinical Field Operations, Clinical Program Management, Document Management).
  • Oversight of the timely capture of accurate quality, clinical adverse event information; and responsibility for resourcing model/plan for assigned therapeutic area(s) teams.
  • Directly responsible for the design and execution of safety management activities including successful completion of CSR deliverables (e.g. narratives), TMF deliverables, etc. Operates independently, with recognition of risk.
  • The potential actions of this position could impact the accuracy of decision-making regarding assigned products in clinical studies with respect to product approval and safety labeling (both marketed/un-marketed), patient safety and patient quality of life. Consequences of non-compliance could result in audits, warnings, penalties and sanctions that could impact both public safety and financial business goals.

Job Requirements:
  • Bachelor' s degree is required in nursing or scientific field. Advanced degree is desirable.
  • 8+ years of clinical development or directly related experience and 4 or more years of direct management experience.
  • Must have demonstrated extensive knowledge in clinical safety reporting with cross discipline exposure and knowledge.
  • Must have proven organizational, project management and leadership skills with the ability to lead the Safety Management organization within a global matrix environment.
  • Must be able to understand the global environment from operations as well as regulatory/GCP perspective.
  • Must have experience building effective working relationships across functions.
  • Must have prior experience in resource planning.
  • Must have demonstrated strong leadership competencies as a Clinical Safety Manager or equivalent with broad business orientation with leadership in standard business procedures (SOP, Global Regulations, OEC, Outsourcing, PV) and the application of those procedures to the business.
  • Must be a subject matter expert, as a leader of initiatives and a key contributor to the advancement of Safety Management as an organization.
  • Expert on Industry Best Practices in Clinical trial Safety that drive process improvement initiatives and implementations within assigned therapeutic areas.

 

Aaron Goldman
Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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