Senior Toxicology Strategist

4 days ago

Watertown, Massachusetts, United States Stratacuity: Proven Scientific Placement Full time

Job Overview:

This role involves driving nonclinical safety strategies, overseeing scientific studies, ensuring regulatory compliance, and authoring regulatory safety documents for clinical development support.

Key Responsibilities:

  • Develop and execute nonclinical safety strategies to support lead selection, candidate nomination, and clinical development.
  • Provide scientific leadership and oversight of in vitro and in vivo nonclinical safety studies, including genetic and general toxicology, safety and secondary pharmacology, and developmental, reproductive, and juvenile toxicology testing.
  • Ensure nonclinical safety assessment studies comply with US FDA and OECD GLP regulations and global nonclinical safety guidelines.
  • Author nonclinical safety-relevant portions of regulatory documents, including pre-IND, IND, and annual updates, as well as briefing booklets for US and ex-US regulatory meetings and filings.

Requirements:

  • DVM/PhD (highly preferred), DVM, or PhD in toxicology, pharmacology, or related field.
  • 12+ years of experience in nonclinical safety assessment in the biotechnology, pharmaceutical, or CRO industries, with at least 5 years in a senior leadership role.
  • Deep knowledge of genetic and general toxicology, safety and secondary pharmacology, DART, and related regulatory requirements.
  • Proven track record in designing, executing, and managing nonclinical safety programs.

About Stratacuity:

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. We will not share your information with anyone without your direct prior consent.

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