Senior Project Toxicologist & Translational Safety Lead (Remote)

BioSpace

Washington (District of Columbia)

Hybrid

USD 180,000 - 240,000

Full time

48 hours ago
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Job summary

Amgen is seeking a Scientific Associate Director - Project Toxicologist to lead nonclinical safety on cross-functional drug development teams. You will shape translational risk strategies, oversee safety programs, and interact with regulatory bodies to inform pivotal development decisions.

The role emphasizes collaboration, leadership, and scientific excellence across modalities and therapeutic areas. The position requires extensive toxicology experience, advanced degrees, and the ability to

Qualifications

  • PhD/MD/PharmD with toxicology experience required.
  • Master's with 7+ years toxicology experience.
  • Bachelor's with 9+ years toxicology experience.
  • Board certification by the American Board of Toxicology is preferred for leadership in nonclinical safety.

Responsibilities

  • Serve as TSRS PTR on core project teams and lead the TSRS sub-team.
  • Design and oversee nonclinical safety programs to support drug development candidates.
  • Develop innovative study designs and NAMs to enhance translational risk assessment.
  • Interpret data and author nonclinical strategy and regulatory submission sections.
  • Communicate effectively with TSRS, project teams, and regulatory agencies.

Skills

Toxicology experience

Education

Doctorate degree (PhD, PharmD, or MD)
Masters degree
Bachelors degree
Board certification by the American Board of Toxicology

Job description

Amgen is seeking a Scientific Associate Director - Project Toxicologist to lead nonclinical safety on cross-functional drug development teams. You will shape translational risk strategies, oversee safety programs, and interact with regulatory bodies to inform pivotal development decisions.

The role emphasizes collaboration, leadership, and scientific excellence across modalities and therapeutic areas. The position requires extensive toxicology experience, advanced degrees, and the ability to

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