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Director, Toxicology

Plano, TX 75063

Posted: 11/01/2022 Employment Type: Direct Hire/Perm Job Category: Clinical Development and Operations Job Number: 507979 Country: United States Is job remote?: Yes

Job Description


Job Summary:

Reporting to the VP Nonclinical Development, the Director, Toxicology is responsible for all safety pharmacology/toxicology programs to support the nonclinical development programs   throughout all phases of drug development from early stage to IND-enabling program and Ph1 . He/She will bring expertise in toxicology with good knowledge of other nonclinical disciplines (Pharmacology and PK). The incumbent will contribute to the global development strategy of the nonclinical department to ensure that appropriate nonclinical safety data is obtained and appropriately integrated with the overall development programs. This individual will also assist in evaluation and selection of potential development compounds as well as preparation of all related nonclinical sections of regulatory submissions and participate in regulatory interaction as appropriate. Additional responsibilities include contracting and managing all nonclinical safety/toxicology studies at external CROs.

Responsibilities:
  • Lead the effort and manage all nonclinical safety pharmacology and toxicology studies executed at external CROs to support the progress of our development programs
  • Assist in NCE lead compound selection and preparation of IND-enabling nonclinical data packages that satisfy global regulatory expectations and requirements
  • Participate in the planning, design, oversight, analysis, and reporting of nonclinical toxicology studies.
  • Key contributor for nonclinical summary documents (2.4; 2.6.6 and 2.6.7) for regulatory submissions (INDs, CTAs, IMPDs, NDAs, etc.) and content for relevant clinical documents (Investigator Brochures, DSUR, RMP, SMPC etc.)
  • Serve as nonclinical representative to cross-function early drug development teams and collaborate with clinical pharmacovigilance teams to develop appropriate early clinical development plans
  • Provide nonclinical input on potential business development opportunities and liaise with key academic collaborators on nonclinical projects
  • Very well versed/familiar with latest regulatory guidance/ICH on safety assessment of small molecules for multiple central and peripheral indications.
  • Work closely with the head of the Department and senior members of the group to execute and achieve departmental goals.
  • Establish cross-functional collaboration with early discovery, medicinal chemistry, CMC and safety groups

**CO candidates may not be considered 
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