- 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.
Requirements
- 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.
Core Competencies
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.
Highest-signal resume keywords
- Clinical Development
- Regulatory Submission
- Study Design
- Cross-Functional Collaboration
- Clinical Operations
ATS Optimization Keywords
Hard Skills
- 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
Soft Skills
- Leadership
- Collaboration
- Decision-Making
- Communication
- Relationship Management
Industry Keywords
- Clinical Science
- Kidney Disease
- Clinical Operations
- Translational Science
- Market Access
- Medical Affairs
- CROs
- External Experts
- Clinical Development Programs
- Clinical Decision-Making