Clinical Research Director - Cardio-Renal - Zurich

Location: Switzerland - Glattbrugg/Zurich

Function: Research and Development

Company: Vifor Pharma

Thomas Lemercier

International Talent Acquisition Manager

+41 58 851 82 73

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About You

We are currently hiring a Clinical Research Director for our dynamic Global Clinical Development team. In this role, you will be a key medical and scientific contributor support and comply the Organization’s duty of care obligations in Global Clinical Development, Pharmacovigilance and Medical Information.

Your responsibilities will include:

  • 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 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 
  • 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)
  • Contribute to 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
  • Serve as a deputy of the Clinical Lead within the respective Vifor Therapeutic Area 
  • Evaluate investigator-initiated protocols and make recommendations (if applicable)
  • 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 applicationsof such products and competitor,  with expert/consultant input as appropriate; interpret and report findings; make recommendations
  • 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
We would like to welcome the following experience and skills for the role:

  • Minimum 8 years pharmaceutical industry experience plus additional medical/health research experience
  • MD or PhD in science / health related discipline
  • Knowledge and experience of clinical trial design, data analysis, statistics and research methods
  • Knowledge of the drug development process and clinical research methodologies
  • Knowledge in Cardiology and or Nephrology would be an asset
  • Ability to work independently and in a fast paced, hands-on, flexible, dynamically changing environment
  • Experience in writing and submission of Health Authority documents is a plus
  • Trained in GCP regulations, and familiar with ICH and FDA guidelines relevant to clinical development

About Us

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.

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