The Clinician, Clinical Scientist (CS) will provide medical and scientific study and project support for multiple, global, Phase 1-4 vaccine clinical studies in a clinical program. They are responsible for working collaboratively with the Clinical Lead Physician and Lead Study Clinician Physicians and will develop study strategies in support of the clinical plans. The CS support includes multiple tasks within the categories of: 1) protocol and study design, strategy, and training, 2) data review and interpretation, 3) study and/or program scientific and integrity oversight, 4) safety review and communication, 5) regulatory document, study report and publication preparation and review, and 6) clinical study implementation oversight, with a critical focus on consistency, quality, data integrity, safety, and alignment with company values. The CS may be assigned to lead implementation of program level activities identified by the Lead Clinical Scientist and Clinical Lead Physician as needed.

The Clinical Scientist is responsible for bringing together clinical, scientific and technical disciplines to ensure high quality protocol development, study execution and data interpretation. They will be responsible for clinical sciences deliverables on one or more interventional clinical trials, with the opportunity to work across multiple Therapeutic Areas within Global Product Development (GPD).

The Clinical Scientist is a key member of the study team and partners closely with the TA clinician and clinical operations team members, applying technical and scientific excellence to support the development and execution of clinical trials to meet the needs of internal and external customers.

Specific clinical scientist responsibilities impact key elements of the study lifecycle including protocol and ICD development, safety and quality data review, patient narratives and Clinical Study Report (CSR) development.

ROLE RESPONSIBILITIES (include but not limited to)

• Provides scientific expertise to produce clinical study protocol
  
  
  • Drives and obtains protocol content and quality review
    
  • Independently writes/designs protocol outlines, protocols, and amendments of moderate complexity in collaboration with the TA Clinician, Global Clinical Lead, Clinical Operations, and other relevant groups
    
  • Ensures study registration forms are complete and protocol amendment forms are updated
    
• Ensures appropriate CRF design, creates ICDs, and is responsible for the selection and implementation of PROs
  
• Partners with data management to develop data review plan for review of data.
  
• Responsible for establishing and management of Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes
  
• Reviews patient level and cumulative data per the data review plan across a study and coordinates with TA Clinician for study level review.
  
• Reviews protocol deviations.
  
• Reviews safety data, SAE reports, TME's, DME's and ensures clinical documents (eg ICD) are updated as required.
  
• Tracks and reconciles serious adverse events (SAEs) across a study and reports SAEs during Safety Review Team meetings.
  
• Collaborates with TA Clinician to provide medical/scientific guidance during the execution of the study.

QUALIFICATIONS & EXPERIENCE

• Required: BA/BS or equivalent qualification.
  
• Preferred: Ph.D., D.V.M., M.S., and/or PharmD. or equivalent qualifications.
  

• Knowledge and experience in Good Clinical Practices
  
• Experience in execution of clinical trials, including data review and investigative site relations
  
• Thorough understanding of local / international regulations applicable to clinical trials (pre and post approval)
  
• Practical experience in clinical trial strategies, methods and processes
  
• Track record of design, oversight and interpretation of clinical studies
  
• Proven scientific writing skills, with strong inter-personal, written/verbal communication skills, including ability to evaluate, interpret and present complex data

The closing deadline for applications is August 29th.

All applicants must have the relevant authorisation to live and work in the UK.