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. 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.
- 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.
- Is a core member of the benefit risk team (BRT), of regulatory submission teams and of the labeling working group.
- 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
- Creation of clinical components of key documents (Clinical Development Plans, Clinical Study Protocols, Investigator’s Brochures, Clinical Study Reports, regulatory documents including maintenance of product licenses, Clinical Modules of registration dossiers, Briefing Books for interactions with Health Authorities) with high quality and consistency with the Integrated Project Plan and Target Product Profile.
- Provision of required input on clinical efficacy, safety, dosing/administration, mechanism of action, etc for the Target Product Profile (TPP)
- 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
- Medical degree with 10+ years of relevant clinical experience in academic and/or pharmaceutical Global Research & Development roles
- Solid track record in drug development programmes, preferably within nephrology
- Extensive knowledge of clinical trial methodology, global regulatory requirements, and experience in designing and executing clinical studies
- Advanced knowledge of clinical trial operational aspects, including budget and timeline management
- Demonstrated ability to build and execute strategic and tactical plans
- Experience engaging with key internal and external stakeholders
- Specialty in relevant therapeutic area with at least 5 years clinical experience treating patients and successful interactions with major Health Authorities leading to drug approvals
- Strong leadership skills with demonstrated capability to lead cross-functional teams in a matrix environment
- Ability to coach, mentor, and communicate effectively with all audiences internally and externally
- Excellent organisational skills with self-motivated drive to implement best practices
- Demonstrated ability to evaluate and analyse medical and scientific literature
- Fluent written and verbal communication in English
- Alignment with Sobi's core values: Care, Ambition, Urgency, Ownership, and Partnership
All your information will be kept confidential according to EEO guidelines.
Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.
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