Job title: Medical Director FIH Oncology – Poland
Company: Barrington James
Job description: Medical Director Clinical Development
I am partnered with an exciting and innovative biotech looking to expand their clinical development team with a Medical director. This person will lead the early phase/ translational oncology pipeline through to phase II.
- Designing the development path of the clinical candidates in the Company portfolio.
- Medical support in developing criteria for the selection of CRO and research centres responsible for preparing and carrying out clinical research.
- Preparing a clinical scenario for a new research with external expert(s) support.
- Analysis, providing opinions and approving clinical test protocols as well as other documentation of the clinical research prepared by CRO based on the previous pre-clinical and clinical data and the planned research targets.
- Ensuring key subject-matter input in the process of creating any regulatory documents (IB, CTA, ODD and clinical research protocols).
- Participation in and subject-matter input in preparing applications for commencement of subsequent clinical research, filed with the competent authorities responsible for approving projects.
- Identification and selection of clinical experts supporting the process of a compound development, preparing documentation required for obtaining a permit to commence subsequent stages of clinical research and experts supporting the research performance.
- Interpretation, analysis and assessment of the safety profile of compounds introduced in clinical development (clinical candidate) as well as pharmacological properties.
- Responsibility for supervision and interpretation of aspects regarding adverse effects. Recommendation of adequate actions with regard to patient safety during the clinical research.
- Maintaining scientific contacts with leading specialists as regards the tested clinical indications.
- Active participation in the work of the design team carrying out the clinical research, and specifically with regard to subject-matter supervision and any medical aspects.
- Medical supervision of the clinical research with particular focus on the aspects of safety of the candidates for medicine.
- Participation in preparing grant applications and reports.
- Active participation in the work and meetings of the Management Team (MT) and Project Management Committee (PMC), including presentation of the results of clinical research.
- Preparing materials, participation and presentation of results and any aspects related to clinical research to external partners (BD) and support of due diligence processes in that regard.
- Medical Doctor
- Clinical experience or specialty in Oncology
- Extensive experience with translational / early phase / FIH
- Experience as a Medical Director in industry (advantageous)
- Experience in clinical monitring and safety (advantageous)
- Hands-on, independent
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