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Director of Clinical Development - Nephrology
Highly Competitive
- Permanent
- Medicinal Chemistry
- Switzerland
Zürich, Switzerland
Posting date:
10 May 2021
36250
This vacancy has now expired. Please see similar roles below...
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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