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Clinical Operations Director

1 month ago

Basking Ridge, New Jersey, United States BioSpace, Inc. Full time
Job Summary

This is a leadership role that oversees the strategic management of one or more complex programs in Clinical Trial Management (CTM). The successful candidate will be responsible for clinical operations activities and decisions, including quality, timelines, and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations, and company Standard Operating Procedures (SOPs) within assigned programs.

Key Responsibilities
  • Oversee the overall success of the clinical study team(s) within a program(s)
  • Maintain an overview of clinical program(s) status and issues and proactively communicate progress, risks, issues, or changes that may impact quality, timelines, and/or budget
  • Provide operational insight into feasibility, timeline, and cost estimates during clinical program/study development
  • Oversee clinical study timelines within a clinical program(s)
  • Provide input and operational insight into Clinical Study Concepts (CSC)
  • Review of plans and provision of clinical operations expertise during protocol design, feasibility, study start-up, and conduct phases of studies
  • Ensure consistency within the program and development of best practices within CTM
  • Oversee clinical study budgets within a program: ensures review, presentation, and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate
  • Ensure timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s)
  • Drive decision-making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation
  • Acts as point of contact for clinical program and study level escalation
  • Review key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress
  • Provide proactive creation and implementation of risk mitigation strategies
  • Provide innovative and flexible operational solutions and options to the cross-functional and development teams; assists in preparing scenarios for creative solutions to operational challenges
  • Drive the strategy and oversight for vendor selection and management within a clinical program(s)
  • Manage the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables and relationship with key CRO (functional and project) and vendor counterparts
Requirements
  • Bachelor's degree
  • Minimum of 12 years relevant industry experience
  • 8 years within clinical trial management

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.

The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.