Clinical Development Director – Nephrology

• Provide scientific leadership across defined components of study design, conduct, data review, and interpretation within assigned clinical programs.
• Develop sections of core regulatory documents.
• Generate the data and evidence required to determine a target's potential efficacy, safety profile, key areas of differentiation and route to becoming a medicine with value to patients in the shortest possible timeframe.
• Define and deliver the clinical pillars of the translational table.
• Deliver clinical development and study timelines and endpoints, including pharmacology, mechanism and clinical efficacy endpoints, enabling key decision points and Go/No Go criteria for the CDP.
• Establish and maintain relationships with program counterparts in Biology, Translational Sciences, Commercial, Regulatory, Clinical Operations, Market Access, Medical Affairs and Statistics.
• Contribute to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Development.

• Bachelor's degree in life sciences, medicine, pharmacy or a related field.
• Experience in clinical development, clinical operations or clinical science roles with a focus on kidney disease.
• Knowledge of and experience in the execution of clinical and/or translational studies.
• Experience and understanding of clinical development from early stage through to regulatory submission, including study design, protocol authoring, and data review/interpretation.
• Knowledge of GCP, ICH, and global regulatory guidelines.
• Experience authoring or contributing to clinical study proposals, protocols, Investigator's Brochures, informed consent forms, clinical study reports, and regulatory submissions.
• Demonstrated ability to operate effectively within cross-functional matrix teams and contribute to clinical decision-making.
• Proven track record of working with investigators, site staff, external experts, CROs, and vendors.

Demonstrates expertise in clinical development and operations, with a strong focus on kidney disease, regulatory submissions, and cross-functional collaboration. Proficient in study design, protocol authoring, and data interpretation, ensuring compliance with GCP and ICH guidelines.

• Clinical Development
• Regulatory Submission
• Study Design
• Cross-Functional Collaboration
• Clinical Operations

• Clinical Study Design
• Protocol Authoring
• Data Review
• Translational Studies
• Clinical Efficacy Endpoints
• GCP Knowledge
• ICH Guidelines
• Clinical Study Reports
• Investigator's Brochures
• Informed Consent Forms

• Leadership
• Collaboration
• Decision-Making
• Communication
• Relationship Management

• Clinical Science
• Kidney Disease
• Clinical Operations
• Translational Science
• Market Access
• Medical Affairs
• CROs
• External Experts
• Clinical Development Programs
• Clinical Decision-Making