Clinical Development Director – Renal

Role Summary

The Clinical Development Director - Renal provides clinical and scientific insights and leadership to clinical and translational studies or programs within the Early Pipeline Unit (EPU) of the RIIRU. The role plans, executes, and delivers renal translational and clinical development strategies and clinical studies, working cross-functionally to develop and execute clinical development plans up to Proof of Mechanism/Proof of Concept stages.

Responsibilities

• Support alignment of translational and clinical plans and study designs with project strategies; develop sections of core regulatory documents.
• Generate data and evidence to determine target or medicines‚Äô potential efficacy, safety profile, differentiation, and route to market with patient value.
• Define and deliver clinical pillars of the translational table; deliver clinical development timelines and endpoints including pharmacology, mechanism, and clinical efficacy endpoints; establish Go/No Go criteria for the CDP.
• Build and maintain relationships with program counterparts across Biology, Translational, Commercial, Research, Regulatory, Clinical Operations, Access, Medical Affairs and Statistics.
• Contribute to implementation and embedding of strategic and organizational initiatives in Clinical Development.
• Provide effective support and oversight of R&D evidence generation activities to assure patient safety and study delivery.
• Contribute to indication planning discussions, incorporating cross-disciplinary input to deliver essential outputs such as early Medicine Profile, Target Validation, Translational Plans, and Candidate Selection.
• Design clinical development plans and study protocols across all development phases, reflecting stakeholder input (patients, regulators, payors, pharmacovigilance).
• Develop clinical study protocols, amendments, investigator brochures, and clinical study reports; provide regulatory input for briefing documents and responses.
• Provide medical monitoring and safety oversight of study participants; ensure scientific integrity and safety of subjects.
• Lead the Clinical Management Team (CMT) on an EPU program; serve as clinical lead at study level; engage with internal and external stakeholders, including regulatory agencies and investigators.
• Collaborate with cross-functional teams to ensure cohesive translational and clinical development plans; stay updated on renal research, trial methodologies, regulatory space, and market landscape.
• Influence across project, departmental, and inter-departmental levels; contribute to clinical components of the Medicine Profile.

Qualifications

• PhD or PharmD (or equivalent) with 1‚Äì3 years postgrad experience; minimum of 3 years of experience in clinical research and development.
• Robust knowledge of renal research priorities, public health needs, and treatment guidelines; experience with global regulatory agencies and management of global nephrology trials.
• Knowledge of regulatory requirements, GCP, and ethical guidelines for clinical research.
• Demonstrated ability to work in cross-functional, matrix environments to design and execute trials to regulatory standards.
• Preferred: Medical Degree and Board certification/eligibility in Nephrology; experience contributing to NDA/BLA/MAA submissions.

Skills

• Clinical development strategy and study design
• Cross-functional collaboration and stakeholder management
• Regulatory and compliance knowledge
• Medical monitoring and safety oversight
• Strategic thinking and problem solving in translational medicine

Education

• PhD or PharmD (or equivalent) required; advanced medical degree preferred for additional qualifications.