Senior Directeur, Medicine Development Leader — Sobi
NouveauCHF 68 000 - 103 000
Sobi · Basel (BS)
- Lieu
- Basel
- Contrat
- full-time
- Publié
- il y a 2 jours
SalaireCHF 68 000 - 103 000
Vue d’ensemble du poste
The MDL leads the Medicine Development Team (MDT) and assures, in close collaboration with the TA head, the appropriate communication flow between the CAT, the MDT and other associated teams (e.g. the Study Team).
- The MDL leads the Medicine Development Team (MDT) and assures, in close collaboration with the TA head, the appropriate communication flow between the CAT, the MDT and other associated teams (e.g. the Study Team).
- Key Responsibilities
- Drives the clinical development strategy for the assigned compound(s) across the medicine lifecycle, from proof of concept to successful global regulatory approval(s)/market access for multiple treatment indications.
- The Medicine Development Leader (MDL) has the overall accountability for developing, driving and representing the clinical development strategy for the nephrology program within the Core Asset Team (CAT), including benefit/risk evaluation, pharmacovigilance (PV) and safety.
- Is a core member of the benefit risk team (BRT), of regulatory submission teams and of the labeling working group.
Responsabilités principales
- Key Responsibilities
- Drives the clinical development strategy for the assigned compound(s) across the medicine lifecycle, from proof of concept to successful global regulatory approval(s)/market access for multiple treatment indications.
- Provides clinical and scientific expertise to set and execute the asset strategy and optimize project success.
- Works with functional members, TA head and CAT Leaders to develop Integrated Project Plans (IPP) documents.
- Identifies risks for the program with other functions and develops mitigation strategies to address them.
- Presents the nephrology clinical program to internal (including the CEO and the Executive Committee of the Organisation) and external stakeholders (Health Authorities, Steering Committees, Independent Data Monitoring Committees, and Patient Organisations etc), engages when necessary with Key Opinion Leaders across geographies.
- Ensures endorsement of clinical development plans and study documents by Sobi governance bodies (e.g.
- Sobi Evidence Generation Board, Study Document Review Forum).
- Leads in a matrix the clinical scientists and the Medicine Development Team (consists of representatives from Medical Affairs, Clinical Science, Regulatory, Safety/PV, non-clinical/PK, Biostatistics/Data management, Clinical Program Management, Heath Economics and Outcome Research, RWE, Program Management), providing strategic guidance and being the ultimate accountable for:
- Clinical trial design (clinical study synopsis and protocol development), planning (e.g. sites and countries selection), execution (e.g.medical monitoring, resolution of safety issues; interpretation of statistical analyses) and internal and external communication of study results
Ce que l’entreprise offre
- The Medicine Development Leader (MDL) has the overall accountability for developing, driving and representing the clinical development strategy for the nephrology program within the Core Asset Team (CAT), including benefit/risk evaluation, pharmacovigilance (PV) and safety.
- Is a core member of the benefit risk team (BRT), of regulatory submission teams and of the labeling working group.
- Support to registration and market access (Core Data Sheet, Development Safety Update Report, Periodic Safety Update Report, clinical benefit-risk assessment) o Collaboration with Regulatory team to determine international submission strategy
