職務說明 / Key Responsibilities

Our client is looking for a nonclinical/preclinical safety expert to be a member of the drug development teams and collaborate to help assure appropriate design and execution of nonclinical safety assessment plans. This includes helping to provide nonclinical input to development plan, assuring successful initiation of clinical trials and achievement of registration for drug candidates, and integrated, scientifically relevant and appropriately compliant nonclinical safety assessment studies to support the development/registration of drugs, and the preparation of regulatory submission documents. Also, provide rapid communication to the project teams on any theoretical or observed safety effects, their effect on the proposed development, plus create a plan to address them. The nonclinical safety expert will collaborate or lead the preparation and presentation of nonclinical safety data in internal and external documents (e.g., Investigator’s Brochure, IND, CTD, IMPD, Health Authority briefing books, etc.) and discussions with Health Authorities.

需求條件 / Key Requirements

• Significant experience in a nonclinical safety or closely-related scientific discipline (e.g. study director, project team toxicologist, biological sciences principal investigator); experience in intact animal and in vitro safety studies
• Experience in the preclinical development of small molecules, complex issue resolution, written and verbal communication; negotiation with global health authorities and IND/CTA/NDA/BLA submission experience is desired
• Experience with literature searches, database queries, in-silico assessments and data mining is desired
• Understanding of regulatory submission components for registration including experience in authoring submission components in Documentum-like system
• The writing of regulatory documents including non-clinical sections in IND’s (Investigational New Drug), CTA’s (Clinical Trial Application) and BLA’s (Biologics License Application). In addition, you contract, monitor, review and sign-off on non-GLP and GLP (Good Laboratory Practice) safety studies conducted at various contract laboratories
• History of successfully managing toxicology projects and working in multiple cross-functional teams
• Capable of directing research at CRO’s and make the needed decisions
• Experience with early and late phase drug development
• Experience with regulatory processes and guidelines as well as with Good Laboratory Practice and other quality systems for the pharmaceutical drug development process