Director, Research Toxicology

Job Description
SUMMARY OF POSITION
The Director of Toxicology is accountable for timely and effective drug safety support for all programs in preclinical or clinical development and for marketed products support. The individual is expected to demonstrate competency in interpreting toxicology data, development and implementation of strategic plans for nonclinical development, as well as providing expertise and guidance in Regulatory Toxicology to project teams and senior management. This individual will be highly analytical, decisive, goal-oriented, and timeline sensitive while maintaining the highest of scientific and ethical standards. The Director of Toxicology will actively participate on project/program/product teams, as well as collaborating with Discovery leadership on NRPC initiatives and assisting senior management in the identification and review of new business initiatives and in-licensing opportunities. The individual will adhere to established processes, policies and quality systems for outsourcing, managing and reporting regulatory toxicology programs, studies and other activities in support of portfolio programs and to provide appropriate content and submission-ready documentation for the toxicology components of regulatory submissions.
MAJOR ACTIVITIES AND RESPONSIBILITIES
Reporting to the Vice President, Regulatory Affairs, the Director, Toxicology will:
• Provide high-level advice to project/program/product teams and senior management, including evaluation of conclusions and potential impact of study results on program and clinical/regulatory strategy.
• Review and approve Toxicology study protocols, reports, associated nonclinical summaries, Regulatory submission sections and associated documentation, as well as abstracts/manuscripts for publication.
• Design, manage, analyze, review, summarize, interpret and report results of Toxicology and Safety Pharmacology studies.
• Maintain up-to-date Toxicology plans (linked to overall NCD plan & IDP) for all projects/programs/products, including listings of studies, timelines, status and costs; update and refine as necessary.
• Provide scientific/technical due diligence support for Business Development activities as required.
• Prepare for and participate in regulatory agency interactions.

ORGANIZATIONAL STRUCTURE
The Director of Toxicology will report to the Vice President, Regulatory Affairs

QUALIFICATIONS AND BACKGROUND REQUIREMENTS
Educational Requirements
• PhD in a related subject, with DABT certification preferred
Professional Work Experience
• 9+ year’s industry-related experience in regulatory Toxicology working within the pharmaceutical industry.
• Hands-on experience in all aspects of Toxicology study conduct including general, genetic, developmental and reproductive toxicology, carcinogenicity, toxicokinetics, and safety pharmacology and environmental risk assessment experience.
• Experience representing function to global regulatory agencies in support of submissions at all stages of development, i.e., IND/CTA, CTD, IMPD, MAA/NDA/BLA/JNDA.
• Demonstrated knowledge of global regulatory requirements and expectations for nonclinical safety assessment packages to support first in human, clinical
Development, and product registration, including thorough knowledge of GLP, GCP, ICH and other applicable global guidelines.
• Extensive experience in the outsourcing and external oversight of nonclinical Toxicology studies conducted by qualified suppliers.
• Experience with both small and macromolecular/biologic drugs is highly desirable.
• Experience in providing formal scientific/technical due diligence support for Business Development activities is required.
• Evidence of leadership within the industry, e.g., such as through peer-reviewed publications or as a participant on expert panels or working groups, is preferred.
• Fluency in written and spoken English is required.

Company

Amicus Therapeutics, Inc

Job Code

State or Province

New Jersey

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