Due to its expanding portfolio, Vifor Pharma has an excellent opportunity for a Clinical Development Director for our nephrology therapy area. This role will be a part of our global clinical development team based in Glattbrugg, Zurich.
Reporting to the Clinical Development Lead for nephrology, the Clinical Research Director will be responsible for medical and scientific contribution to protocols, new product and indication opportunities, drug safety, study reports, IBs, regulatory submissions, manuscripts, medical education, and other projects requiring medical/scientific research, analysis, evaluation, training and reporting.
Job impact: This is a unique opportunity to work on a portfolio of nephrology products. The incumbent will be working on multiple projects at various phases of clinical trials. It provides a good balance between strategic and hands on clinical development work.
Key responsibilities (but not limited to):
- 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 finalization
- 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)
- Educational background: MD with clinical practice experience in nephrology
- 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
If this opportunity is of interest to you, please apply by submitting your updated CV via our careers website.