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Global Head of Nephrology Safety

Reference Number: 2980
Location: East Coast

Our client is a leading pharmaceutical company.  They have asked us to assist them in their search for a Global Head of Nephrology Safety.

The Global Head of Nephrology Safety will focus on supporting superior patient safety and will promote the application of cutting edge science, methodologies and technologies related to Nephrology for this purpose.  The incumbent will be the clinical representative of the Renal safety knowledge group (SKG), an international network of individuals with experience and an interest in the different aspects of preclinical and clinical safety during drug development.

Major tasks and responsibilities will include:

  • Provides expert scientific and/or medical input to Patient Safety activities, with special focus on cross-project and cross-TA activities of a scientific nature.
  • Contributes to development of strategies to ensure that scientific assessment, mitigation and prevention of risk to patients are on a leading pharmaceutical industry level.
  • Contributes to safety biomarker development.
  • Contributes to development of scientific methods applied to a wide range of safety data.
  • Promotes safety science across projects and TAs.
  • Provides support, as needed, for discussions with international regulatory bodies.
  • Contributes to develop better understanding and prevention of safety issues across functions within the company and across Pharmaceutical Companies and Regulatory Authorities.
  • Identifies and represents the company on relevant external consortia.
  • Contributes to successful implementation of the global working model for the Safety Science Section.
  • Provides expertise in clinical Nephrology, and related modalities and biomarkers to assess injury and disease.
  • Clinical lead to Renal SKG work internally and to external initiatives.
  • Advocate for Renal SKG raising the awareness and impact of the SKG on clinical programs and in various preclinical settings.
  • Contributes to Renal safety biomarker development and preclinical strategies.
  • Actively participates in applied scientific research in the area of expertise internally and via participation in external consortia.
  • Identifies and manages an internal network of functions needed to support SKG activities.

We seek candidates with the following qualifications:

  • MD with Nephrology Specialty training and board certification.
  • Expertise in drug-induced kidney injury.
  • 5+ years of drug development/safety experience the majority of which should be in industry with clear evidence of delivery.
  • Recognized by peers for therapeutic area expertise and commercial/safety understanding.
  • Ability to balance business and clinical research objectives.
  • Experience working with regulatory agencies, preparing regulatory documents and overseeing submissions.
  • A thorough knowledge of the pharmaceutical industry, especially clinical research and global regulatory requirements and practices governing expedited and periodic safety reporting, signal generation, safety evaluation and risk management activities.
  • Proven high quality scientific record.
  • Demonstrated capability to lead implementation of new technology and/or working routines within a complex organization.
  • Excellent verbal and written communication skills.
  • Experience in leading of cross-functional teams.
  • Broad knowledge of drug development.
  • Experience in Patient Safety/Pharmacovigilance preferred.
  • Extensive experience in managing or designing clinical trials which require close monitoring desirable.
  • Experience with strategic decision-making.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2980. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.