Medical Director – Clinical Development, Nephrology

Support alignment of translational and clinical plans and study designs with project strategies to ensure quality design and execution of the CDP.
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.
Provide effective support and oversight of R&D evidence generation strategy, plan and activities to ensure patient safety and on-time, in-full study delivery.
Contribute to the study team discussions on indication planning and incorporate input from across disciplines (scientific, clinical, commercial, regulatory, stats, etc.) to contribute to vital deliverables including early medicine profile, target validation, translational plans, candidate selection.
Design clinical development plans, study protocols and associated documents across all phases of development, reflecting internal and external stakeholder input (e.g., patients, evidence generation, regulators, payors, pharmacovigilance).

• Medical Degree
• Completion of a formal postgraduate clinical training, clinical residency or specialty training in Internal Medicine, Pathology, etc
• Demonstrated experience in clinical trial conduct, including medical monitoring, safety review, and clinical data interpretation
• Strong working knowledge of clinical development processes, including GCP, ICH guidelines, and global regulatory frameworks
• Ability to apply clinical judgement to support study design, patient safety, and real-time medical decision-making within a structured clinical development framework
• Experience operating effectively within cross-functional matrix teams in a pharmaceutical, biotechnology, or academic clinical trial environment
• Strong scientific communication skills, with the ability to translate clinical data into clear insights for internal and external audiences.

Demonstrates expertise in clinical development processes, including the design and execution of clinical development plans and regulatory documents, while ensuring patient safety and effective communication across cross-functional teams.

• Medical Degree
• Clinical Trial Conduct
• GCP Knowledge
• Clinical Data Interpretation
• Cross-Functional Team Collaboration

• Clinical Development Processes
• Regulatory Document Development
• Study Protocol Design
• Pharmacovigilance
• Clinical Monitoring
• Safety Review
• Efficacy Assessment
• Evidence Generation Strategy
• Clinical Judgement Application
• Study Timeline Management

• Scientific Communication
• Interpersonal Skills
• Decision-Making
• Collaboration
• Organizational Skills

• Postgraduate Clinical Training
• Clinical Residency

• Translational Medicine
• Biotechnology
• Pharmaceutical
• ICH Guidelines
• Global Regulatory Frameworks
• Clinical Operations
• Market Access
• Medical Affairs
• Internal Medicine
• Pathology