Scientist for Clinical Trials--Vaccines (Director)

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Scientist for Clinical Trials--Vaccines (Director)

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Position Summary

You will provide clinical and scientific program support for a global clinical sciences team on a program, ensuring consistency of approach and strategy and appropriate oversight of activities within a program or provide clinical and scientific support for multiple, global, Phase 1 - 4 clinical studies. You will be responsible for clinical sciences project management support on a program level and/or responsible for studies with a high degree of complexity. You will work collaboratively with clinical colleagues and you may develop clinical development plans and study strategies in support of the plans.

Position Responsibilities

• Maintain current scientific and clinical knowledge in the vaccines therapeutic and disease area(s)
• Along with the Global Clinical Lead, responsible for the design, scientific oversight, data integrity and quality of the clinical studies within the assigned program.
• Author or oversee authoring of protocols, study level informed consent documents, and contribute to authoring of site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents.
• Partner with other clinical colleagues, clinical operations and other functional lines for the successful and consistent implementation and execution of the clinical studies within the assigned program.
• Set the clinical data review strategy and lead the clinical sciences team in the collection of quality data and review of emerging clinical data and trends; reviews and queries data; presents and discusses relevant data to appropriate teams, and other internal and external stakeholders.
• In close partnership with medically qualified colleague(s), analyze the emerging safety profile of the drug, keeping the clinical and safety colleagues informed of changes in the safety profile as they occur in the assigned studies.
• Follow relevant SOPs and regulations, comply with applicable trainings, seek opportunities to further improve quality and efficiency of clinical procedures; lead or actively participate in portfolio- and enterprise level workgroups aimed at optimizing PFE clinical development procedures; may be a subject matter expert or business process owner for a relevant SOP or procedure.
• May supervise, mentor, and/or develop others.
  
  

• BA/BS Degree in a science or health-related discipline
• Advanced knowledge of the clinical research process and Good Clinical Practices from previous employment experience.
• Extensive experience in the vaccines therapeutic area.
• Proven record of independently writing clinical protocols and study documents.
• Working knowledge of statistics, data analysis, and data interpretation.
• Process improvement experience
• Exceptional written and oral communication and cross-functional collaborative skills.
• Proficient in MS Word, Excel, and PowerPoint.
• Significant experience leading operational and/or strategic teams.
  
  

• MS, PhD or Pharm D
  
  

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Pharmaceutical Manufacturing

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