Clinical Program Leader (CPL) Support
Provide expert reports on a range of topics in support of the clinical development projects overseen by the CPLs in the Therapeutic Area CNS Medicine group. CPLs will for each topic outline in more detail the request and expected deliverable and timelines and will occasionally review progress and draft reports. CPLs provide the necessary background information and/or literature.
Specifically, topics in support of the clinical development projects in the Therapeutic Area CNS Medicine group include:
- Development of a clinical development plan from phase 1 to submission for new indications (Fragile X syndrome, Progressive Myoclonal Epilepsy). This includes a review of the literature, consideration of regulatory guidelines, suggestions for relevant clinical endpoints and trial concepts, in particular also translational medicine studies.
- Propose an outline and concept for phase 2 studies in Alzheimer Dementia
- Provide a synthesis of literature review of adequacy of functional assessments for cognitive impairment in schizophrenia
- Provide a synthetic overview of published studies in cognitive impairment in schizophrenia
- Literature and database search about pathophysiological background and relevance of a specific mode of action for further indications
- Evaluation and comparison of assessment tools for impulsivity in BPD, ADHD, Binge eating, substance abuse disorders (alcohol/cocaine/nicotine)
- Critical Review and Input to translational Medicine studies in CIAS projects
- Medical and clinical experience in a broad range of Central Nervous System disorders
- Experience in operational and strategic aspects of clinical research and drug development
- Experience in interactions with regulatory authorities
Verfügbarkeit: 20 h/week remote – Progress is monitored in occasional meetings and telephone calls, there may be occasional travel to meetings, which can occur on BI site.
Projektlaufzeit: Individual projects may require between 40 and 100 working hours. The overall duration of support runs approx. 6 months/524 hours