REMOTE Senior Director Clinical Development - Vaccines

Job Reference: #61047 Add to saved jobs

  • Location Remote, USA<br />USA
  • Permanent
  • Sector Pharmaceuticals

Job Summary

An exciting remote opportunity has just emerged with a late stage cutting-edge biotech who are dedicated to developing Vaccines. This company has a diverse pipeline and is looking for a Senior/ Director of Clinical Development to come in and join their team. This position’s primary role is to execute clinical trials effectively and efficiently. As the Senior/Director of Clinical Development, this position plays a large leadership role within the organization. This position acts as the Clinical science lead and holds the responsibility for developing and executing the Clinical Development Plan.

Job Overview

• Develop clinical trial protocols, design, investigator brochures, and other documents relating to clinical trial conduct.
• Acts as an expert within the clinical development and assists generating and executing the clinical research strategy across preclinical development, clinical research, manufacturing, and regulatory affairs.
• Generates, executes, and preserves the project CDP and other clinical documents that remain consistent with the project goals. Reviews study documents like study protocol, CRFs, SAPs, etc.
• Assists in identifying additional opportunities within the R&D portfolio.
• Ensure all clinical programs are operated in accordance with Good Clinical Practice (GCP) and Support of regulatory functions for clinical sections of INDs, IB, NDA, and other communications.
• Represent clinical and medical strategy to internal and external stakeholders.

Skills Required


• Doctor of Medicine (MD) degree or equivalent and 5+ years in clinical research or drug development.
• Therapeutic expertise and clinical research experience in Vaccines or Infectious Disease
• Experience in Phase I – IV Clinical Development from working for a pharmaceutical, biotechnology, or CRO company
• Strong knowledge and understanding of GCP, Clinical Research, Fundamentals of Project Management, working in matrix-based environment is required
• Strong analytical, planning, medical/scientific writing skills required
• Experience in IND filing

Contact Details

Full job description and company details are available upon application. This position is being dealt with by Kaitlyn Sumner at Meet, email directly at kaitlyn@peoplewithchemistry.com to discuss further and in confidence.

You can find out more about Kaitlyn & Meet at www.peoplewithchemsitry.com

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