Director Clinical Research

2 weeks ago

Princeton, United States System One Holdings, LLC Full time

Title: Director of Clinical Research

Location: Must be local Princeton, NJ

Type: Perm

Start Date: ASAP

Leading Pharmaceutical Company located in NJ is hiring a Director of Clinical Research w/ 10+ years industry experience. If you want to be a part of this groundbreaking work, please apply

  • Prefer a Rare Disease background but not required
  • Must have a MS or above
  • 5yrs of people management - will oversee 3-5 people
Responsible for:
  • Supervise the members to work for appropriate actions in the department and with other departments or organizations.
    • Manage, oversee, and mentor subordinates, including controlling staff's workload.
    • Collaborate with other department heads and the Head of Clinical Development to enhance and maintain productivity in this group.
  • Research all available scientific information, interview external experts, organize appropriate advisory boards, and leverage the results of these activities, in order to provide scientific information on the Clinical Development Plan (CDP).
  • Provide all necessary leadership and guidance to keep the quality of clinical study-related documents (clinical study protocol (PRT), investigator's brochure (IB), clinical study report (CSR), medical monitoring plan (MMP), safety management plan (SMP), informed consent form (ICF), clinical study data listing/table and regulatory agency/IRB submission document); oversee, write and/or review clinical study-related documents listed above.
    • Collaborate/manage internal and external team members and investigators to review, interpret, and summarize clinical study data and results for finalizing the clinical study topline reports.
Minimum Experience Requirements:
  • Minimum 5 years of experience as a manager
  • Minimum 10 years of experience in planning/developing, and managing clinical studies within the pharmaceutical industry.
  • Minimum 5 years of experience in supervising the development of clinical study-related documents (e.g., PRT, IB, CSR, MMP, SMP, and regulatory documents)
  • Strong and diverse scientific expertise and/or strong medical background in disease/therapeutic area or clinical safety assessment
  • Knowledge of clinical development-related regulations such as GCPs, ICH guidelines, and requirements for the successful conduct of clinical studies
  • Basic working knowledge of clinical databases, statistics, and pharmacokinetics
  • Attention to detail and ability to process and prioritize complex information and multiple tasks and ability as a hands-off style manager.
  • Ability to collaborate others and work effectively and together.
  • Working knowledge of MS Excel, Word and PowerPoint and related medical writing software

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