Due to its expanding portfolio, Vifor Pharma has an excellent opportunity for a Clinical Development Director for our cardiorenal 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 Cardiorenal, 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.
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 (strongly preferred) or internationally recognized equivalent degree or PhD in science/health-related discipline
6 to 8 years of pharmaceutical industry experience gained in clinical research
Experience in phase 3 and 4 clinical studies/outcomes trials is an advantage
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 Cardiology and/or 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.
Vifor Pharma Group is a global pharmaceuticals company. It holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).