Clinical Research
Vifor Pharma
Switzerland - Glattbrugg-Zurich
vor 12 Tg.

Votre profil

We are seeking a Clinical Research Senior Manager to join our Global Clinical Development team in Zurich. You 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 in the Iron Deficiency Therapeutic Area (TA).

Reporting directly to the Clinical Lead, TA. Iron, your tasks and responsibilities will include, but not be limited to, the following :

  • Member of cross-functional team within Research & Development
  • Provide effective and innovative clinical trial designs with literature research and expert input
  • Author protocols, and provide scientific input into manuscripts / publications, IBs, regulatory and study reports
  • Provide scientific / medical input to Statistical Analysis Plan (SAP) content development
  • 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

  • Perform ongoing scientific data analysis for clinical trials as a part of signal detection in clinical trials
  • Assess safety data including labs and SAEs on an ongoing basis for ongoing clinical trials; manage Data Safety Monitoring Board (DSMB) or Clinical
  • Endpoint Committee (CEC) processes for clinical trials
  • Provide scientific support for Clinical Operations team members
  • Provide Medical Oversight and Medical Monitoring to interventional clinical trials
  • Contribute to the Clinical Development Plans of projects within the Vifor Pharma project portfolio
  • Maintain and evaluate current knowledge of key disease areas, providing information to appropriate groups as needed
  • Evaluate investigator-initiated protocols and make recommendations
  • 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;
  • expert input as appropriate; interpret and report findings; make recommendations

  • Medical / scientific training for internal staff, service providers, investigators and others, as needed
  • Comply with all signatory limits as communicated by the finance function on behalf of the company
  • Comply with all Corporate Policies, rules, and regulations as set out and communicated by the company pursuant to good business practice
  • Travel across Europe six times per year
  • The ideal candidate holds an M.D. or PhD in a Life Science field in additional to the following experience :

  • Minimum 5 years pharmaceutical industry experience plus additional medical / health research experience
  • Knowledge and experience of clinical trial design, data analysis, statistics and research methods
  • Knowledge of the drug development process and clinical research methodologies
  • You are a fast learner and are able to get up to speed with concepts in a short amount of time. You are able to work autonomously and as part of a team.

    You have excellent communication skills and are willing to contribute at all levels. You act as a role model for others in line with Vifor Pharma values.

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