Senior Director, Medicine Development Leader — Sobi
- Location
- Basel
- Contract
- full-time
- Posted
- 48 days ago
Role overview
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.
Main responsibilities
- 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
What the company offers
- 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
Questions about this listing
What salary does Sobi offer for this role?
Sobi lists CHF 85'500 - 129'500 gross per year for this position in Basel. This is the salary published in the original listing (or, when the employer omits a figure, a realistic estimate for the role and sector) — the calculator on this site converts it to your actual net take-home once cross-border tax and social contributions are applied.
Is this a full-time role, and what type of contract does Sobi offer?
This listing is a full-time position. The contract type shown here comes directly from the employer's original posting; always confirm exact hours, notice period and probation length with Sobi during the application process, since these details can vary by role even within the same contract category.
Do I need a cross-border work permit for a role in Basel?
EU/EFTA residents living in the border zone of the country adjoining Canton Basel can apply for a G permit; the Swiss employer files it with that canton's migration office after the contract is signed. Border-zone rules and processing times vary by neighbouring country and canton, so confirm the specifics with Basel's cantonal migration office or with HR during the application.
How do I apply for this position at Sobi?
Use the "Apply now" button on this page — it links directly to Sobi's original listing at jobs.smartrecruiters.com, so your application goes straight to the employer's own applicant-tracking system. Frontaliere Ticino does not collect or forward applications itself.
