Hobson Prior are currently recruiting for a Senior Clinical Scientist to join a pharma and biotech organisation who are focused on the manufacturing of drugs that treat rare diseases and orphan diseases. This position will be primarily plan, design, scientifically monitor and report clinical studies.
Please note that to be considered for this role you must have the right to work in this location.
- Accountable for delivering the clinical study protocol and contributes to the development of other clinical study documents, e.g. Informed Consent Form, Case Report Form, etc.
- To perform medical monitoring/ reporting including evaluation of adverse events.
- Reviews, evaluates and reports results of clinical studies.
- Plans, manages and monitors daily activities of clinical studies which require scientific input, e.g. contribution to answers to trial-related Health Authorities' (HA) questions, answer to Ethic Committees /Institutional Review Boards questions, etc.
- Manages study-related committees, external medical experts etc.
- Ensures that all activities are compliant with the department, company and regulatory standards and procedures.
- As requested, contributes to the development and execution of clinical research programs for assigned company products, e.g. Clinical Development Plans, Clinical
- Overviews, HAs' Briefing Books, HAs' Annual Reports, Pediatric Investigational Plans, etc.
- As requested, participates on cross functional teams, e.g. improvement of processes, etc.
- Good leadership and analytical skills.
- Excellent computer systems and software skills.
- Excellent English however other languages are advantageous.
- Doctorate (DDS, DVM, PhD, PharmD), MSc or equivalent degree in Biological Sciences required.
- At least 5 years' experience in Clinical Development, and hands on experience on conducting clinical trials.
- You will have knowledge of clinical development processes, clinical trial processes, and regulatory requirements/ ICH guidelines based on previous deliverables.
- Previous experience of working in a matrix organization including interactions with all relevant functions involved in a clinical trial and program (e.g. Biostatistics, Data Management, Operations, Regulatory, Drug Safety, external service providers, etc.).
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.