Vice President of Clinical Trial Operations

2 weeks ago

San Francisco, California, United States Mcure Biosciences Full time
Job Overview

Position Title: Vice President of Clinical Trial Operations

Company: Mcure Biosciences Inc.

About Us: Mcure Biosciences is an innovative startup focused on advancing healthcare solutions. We are gearing up to initiate clinical trials and are in search of a seasoned Clinical Operations Executive to enhance our team.

Role Summary: The Vice President of Clinical Trial Operations will be instrumental in directing and supervising our forthcoming clinical studies. The ideal candidate will possess significant expertise in monoclonal antibody research, with experience in both domestic and international settings. Familiarity with intensive care unit (ICU) operations and infectious disease studies is highly advantageous.

Core Responsibilities:

  • Lead the strategic planning, execution, and oversight of clinical trials.
  • Ensure adherence to regulatory standards and clinical trial protocols.
  • Collaborate with multidisciplinary teams, including contract research organizations (CROs), medical professionals, regulatory bodies, and quality assurance teams.
  • Manage clinical trial sites, encompassing selection, initiation, and ongoing monitoring.
  • Develop and uphold study timelines, financial plans, and resource allocation.
  • Prepare and submit necessary regulatory documentation and reports.
  • Guarantee data integrity and quality throughout the clinical process.
  • Foster relationships with external vendors and stakeholders.

Required Qualifications:

  • Bachelor's degree in a relevant discipline.
  • Demonstrated experience in clinical operations, particularly in monoclonal antibody trials.
  • Experience in ICU settings and infectious disease trials is highly preferred.
  • In-depth knowledge of FDA regulations and ICH-GCP guidelines.
  • Exceptional project management and organizational capabilities.
  • Ability to operate independently and collaboratively in a dynamic environment.
  • Strong communication and interpersonal skills.

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