Senior Director, Medicine Development Leader

About the role

The Medicine Development Leader (MDL) is accountable for shaping and executing the clinical development strategy of Sobi’s nephrology program. Reporting to the Therapeutic Area head, the MDL leads a multidisciplinary Medicine Development Team and ensures alignment with the Core Asset Team and broader organisational goals.

Key responsibilities

• Define and drive the clinical development strategy from proof‑of‑concept through global regulatory approval and market access for multiple indications.
• Lead the Medicine Development Team, coordinating Medical Affairs, Clinical Science, Regulatory, Safety/PV, Biostatistics, Health Economics, RWE and Program Management.
• Develop Integrated Project Plans and oversee clinical trial design, site selection, protocol development and execution.
• Present program updates to internal senior leadership, health authorities, steering committees and patient organisations.
• Participate in benefit‑risk assessments, regulatory submissions, labeling work‑groups and governance reviews.
• Identify program risks, devise mitigation strategies and ensure compliance with Sobi governance bodies.

Required profile

• Extensive experience leading clinical development programmes, preferably in nephrology or related therapeutic areas.
• Proven ability to manage large, matrixed teams across multiple functions.
• Strong communication skills for interaction with senior executives, health authorities and external key opinion leaders.
• Demonstrated track record of delivering successful regulatory submissions and market access.

Required skills

• Clinical trial design and protocol development
• Pharmacovigilance (PV) and safety monitoring
• Benefit‑risk evaluation
• Regulatory submission preparation
• Labeling and product licensing
• Statistical analysis and biostatistics
• Data management
• Health economics and outcomes research
• Real‑world evidence (RWE) generation
• Program and project management