Director of Clinical Development - Nephrology

An excellent opportunity has arisen for a Clinical Development Director to oversee the Nephrology Therapy. You will be responsible for medical and scientific contribution to protocols, IBs, regulatory submissions and evaluation.

Job Responsibilities

• Leadership of clinical study/program to ensure delivery of clinical trials per ICH-GCP requirements and meeting timelines and budget
• Leadership and moderation of clinical advisory boards and ongoing interactions with applicable committees relevant to successful conduct of studies and programs
• In collaboration with a cross-functional team, drive the development of effective and innovative clinical trial designs, and facilitate execution of clinical trials by supporting site and CRO personnel, safety monitoring activities, data clean-up activities, data analyses, and clinical study report development and finalisation
• Author protocols, and provide scientific input into manuscripts/publications, IBs, regulatory and study reports
• Research and analyse scientific/medical information and data with respect to clinical trials, safety databases, and other medical/scientific elements necessary for decision-making and regulatory submissions
• Assess safety data including labs and SAEs on an ongoing basis for ongoing clinical trials; manage DSMB processes for clinical trials
• Represent the company as the scientific subject matter expert at external meetings including those with Investigators, Steering Committees, Key Opinion Leaders and Advisory Groups
• Provide Medical Oversight and Medical Monitoring to interventional clinical trials (supported by CROs, if applicable)
• Maintain and evaluate current knowledge of key disease areas, providing information to appropriate groups as needed
• Evaluate investigator-initiated protocols and make recommendations (if applicable)
  
  

Skills and Requirements

• MD (strongly preferred) or internationally recognized equivalent degree or PhD in science/health-related discipline
• 6 to 10 years of pharmaceutical industry experience gained in clinical research
• Knowledge and experience of clinical trial design, data analysis, statistics and research methods
• Knowledge of the drug development process and clinical research methodologies
• Trained in GCP regulations, and familiar with ICH and FDA guidelines relevant to clinical development
• Experience in Nephrology clinical trials would be preferrable
• Experience in writing and submission of Health Authority documents (e.g., NDA, sNDA, MAA) desired
• Ability to work independently and in a fast paced, hands-on, flexible, dynamically changing environment

To Apply

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