Manager Clinical Development (m/f)

REFERENZNUMMER:

304202/8

IHRE AUFGABEN:

-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

IHRE QUALIFIKATIONEN:

-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

WEITERE QUALIFIKATIONEN:

Clinical project manager