Job title : Pharmaceutical/ translational research Clinician
Location – Porton Down, SP4 0JQ
Salary – Highly Competitive Day Rate
Contract - 14 months
IR35 IN SCOPE
SC clearance required for successful candidate.
MOD will only consider applications from British Nationals due to security clearance requirements.
Contractor for DSTL/MOD
Main objective is to provide advice, options and solutions, to support the generation of Clinical strategies for novel medical countermeasures to chemical & biological warfare agents.
• Demonstrate expert ability to design, manage, interpret and report clinical studies from Phase I to Phase III.
• Demonstrate technical knowledge and innovation in clinical development study design that provides relevant evidence of progression from pre-clinical to clinical.
• Strong track record of successful work leading to regulatory submissions for novel medicinal products to Competent Authorities that is supported by publications and references.
• Experience of preparing and reviewing documentation for submission to Regulatory bodies including Investigator Brochures, Investigational Medicinal Product Dossiers, Clinical study protocols, Common Technical Documents, Paediatric Investigational Plans / Waivers, Marketing Authorisation Applications.
• Practical working knowledge of relevant current ICH and EU guidelines / directives on safety, efficacy, quality and multidisciplinary topics, and currency with the changing regulatory landscape.
• Expert practical working knowledge of relevant cGLP and cGCP regulations and familiarity with cGMP requirements.
• Detailed first-hand knowledge and understanding of the drug discovery and development processes.
• Broad professional experience obtained in appointments within the biotechnology or pharmaceutical sectors or regulatory authorities.
• Able to work with the Dstl project team(s) and external project consultants.
• Able to provide training and mentoring support and advice to clinicians within Dstl as part of good governance
• Provide expert advice, including provision of options and solutions, to support the generation of clinical strategies for novel medical countermeasures to chemical and biological warfare agents.
• Provide expert clinical advice, including options and solutions, to broadly support development and future licensure of novel medical countermeasures.
• Advise on clinical study plans, study design, regulatory requirements, and execution of clinical studies from first-in-human trials through to late-stage development studies. A working knowledge of cGxP requirements is essential.
• Provide expert advice, analysis and interpretation of clinical data. Generate robust conclusions based on the data and provide options, solutions and recommendations to enable the execution of a concise and effective clinical development plan.
• Provide third party expert advice and review of relevant non-clinical activities and data such that clinical development plans can be delivered to regulatory requirements.
• Review protocols and data, and provide interpretations of data and recommendations for future work / experimental studies to support product development.
• Prepare and review documentation for submission to Regulatory bodies including, but not limited to, Investigator Brochures, Investigational Medicinal Product Dossiers, Clinical study protocols, Common Technical Documents.
• Provide advice and recommendations to ensure that the Dstl project team(s) deliver novel pharmaceutical products through the drug development process.
• Act as a Subject Matter Expert mentor for Dstl staff supporting Clinical studies and Regulatory submissions within the Advanced Development Projects.
• Challenge constrained thinking within the project teams and provide alternative solutions to problems that are consistent with current Regulatory guidelines.
• Attend project team meetings / review meetings as required by the Dstl Project Teams.
• Provide training and mentoring support and advice to clinicians within Dstl as part of good governance.
• Commit to be available to respond to queries within a timely manner (typically within 5 working days).
MBChB, MBBS, MD or equivalent medical degree
Current professional registration with appropriate college
Registered with GMC