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.
• 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.
• 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
Full job description and company details are available upon application. This position is being dealt with by Kaitlyn Sumner at Meet, email directly at firstname.lastname@example.org to discuss further and in confidence.
You can find out more about Kaitlyn & Meet at www.peoplewithchemsitry.com