Description
We are looking for a
Manager Clinical Development (m/f)
Reference: -en
Start: asap
Duration: 6 MM
Place: remote and in Thuringia
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Contribution to target product profiles
- Development, presentation and writing of clinical development plans
- Support in the medical/scientific planning, organisation and execution of KOL Contacts
- Preparation of briefing documents for pre-IND meetings, EMA scientific advice, IND submission (clinical parts)
- Designing clinical studies (development of extended study synopsis) in close collaboration with external biostatistician and internal clinical study managers
- Preparation of clinical study protocols in close collaboration with internal clinical study managers
- Preparation of orphan drug applications
- Support of clinical study managers in preparation (and execution) of clinical trials
Your qualifications
- Experiences with clinical development
- Experiences with the indications dermatology, rheumatology, chronic autoimmune disorders, immune modulating monoclonal antibodies, pneumonia, sepsis
- Experiences with the development of monoclonal antibodies
- Relevant regulatory experiences in the respective indications
- Hands-on experiences with writing regulatory and clinical briefing documents (e.g. pre-IND, scientific advice)
- Hands-on experiences with writing clinical study protocols
Skills:
- Clinical project manager
Keywords: Clinical Project Manager