Location: Switzerland - Glattbrugg/Zurich
Function: Research and Development
Company: Vifor Pharma
We are currently looking for a Clinical Research Manager to join our Global Clinical Development department. Reporting to the Clinical Lead for the Therapeutic Area Nephrology, you will be responsible for medical and scientific contribution to interventional clinical study protocols, new product and indication opportunities, clinical development plans, clinical study reports, and Investigator Brochures. In cross-functional teams you will interact with other stakeholders to evaluate the benefit-risk assessment of products, and to support further activities including annual safety reporting, regulatory submissions, medical manuscripts, medical education.
Your responsibilities will include, but not be limited to, the following:
- Be a member of a cross-functional team in research and development of effective and innovative clinical trial designs, with literature research and expert/consultant input as appropriate
- Scientific input to SAP development
- Evaluate investigator-initiated protocols and make recommendations
- Research and analyze scientific/medical information and data with respect to clinical trials, safety databases, and other medical/scientific elements necessary for decision-making and regulatory submissions
- Author protocols and provide scientific input into manuscripts/publications, IBs, regulatory and study reports
- Perform ongoing scientific data analysis for clinical trials as a part of signal detection in clinical trials
- Provide Medical Oversight and Medical Monitoring to interventional clinical trials (supported by CROs, if applicable)
- Assess safety data including labs and SAEs on an ongoing basis for ongoing clinical trials; manage DSMB processes for clinical trials
- Provide scientific support for Clinical Operations team members
- Maintain and evaluate current knowledge of key disease areas, providing information to appropriate groups as needed
- Prepare and present medical education materials, medical/scientific materials at investigator meetings, internal training materials with respect to medical/scientific issues
- Provide medical/scientific research and evaluation of potential new products and applications of such products and competitors
- Medical/scientific training for internal staff, service providers, investigators and others as needed
- You will agree to comply with all signatory limits as communicated by the finance function on behalf of the company
- You will comply with all Corporate Policies, rules, and regulations as set out and communicated by the company pursuant to good business practice
The ideal candidate is holding a PhD level degree, though preferably a MD degree. Additionally, you bring the following profile:
- Minimum 2 years previous experience in the pharmaceutical industry with additional medical/health research experience
- Experience and knowledge of clinical trial design, data analysis, statistics and research
- Knowledge of the drug development process and clinical research methodologies
- Experience and very good knowledge in Nephrology and/or Orphan diseases would be advantageous
You are a motivated worker bringing a passionate approach. You able to work independently but also able to act effectively as a team member in a cross-functional team, providing support also for other groups and are willing to contribute at all levels. Moreover you are a fast learning person willing to constantly catch-up on current disease areas and medical/scientific information, working to high ethical standards and integrity.
Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives. Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world. The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.
Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.
For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are.