• 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).
There is an enduring requirement for Dstl to support the development of Medical Countermeasures to chemical and biological warfare agents for MoD. A complex and changing regulatory environment exists for the provision of novel pharmaceutical products and on-going expert advice on clinical strategies and clinical study execution is required to progress and support new medicinal therapies through to licensure by Competent Authorities (e.g. Medicines and Healthcare products Regulatory Agency - MHRA and the European Medicines Agency - EMA)