Senior Director, Product Toxicology & Stewardship

Amgen; Thousand Oaks (CA); Hybrid; USD 211,000 - 286,000; Full time

Benefits offered by this job

Flexible work models

Total rewards program

Stock-based incentives

Job summary

Amgen is seeking a Scientific Director, Product Stewardship Toxicology, to provide strategic scientific leadership within EHSS. You will guide toxicology programs across development, manufacturing, and lifecycle management to ensure patient and worker safety and regulatory compliance.

The role requires deep expertise in pharmaceutical toxicology, occupational toxicology, and extractables/leachables, with strong leadership and collaboration across functions.

Qualifications

• Doctorate or equivalent in toxicology or life sciences; relevant post-doc experience preferred.
• Advanced degree with extensive toxicology/pharma experience and regulatory exposure.
• Strong scientific communication and leadership capabilities.

Responsibilities

• Provide strategic leadership for Product Stewardship Toxicology within EHSS.
• Develop toxicology strategies across global development and lifecycle management.
• Lead toxicology risk assessments for regulatory submissions and quality decisions.
• Oversee occupational toxicology, OELs, and hazard communication.
• Support medical devices and ISO 10993 evaluations and submissions.
• Mentor scientific talent and drive cross-functional project excellence.

Skills

Toxicology leadership

Regulatory knowledge

Scientific writing

Project management

Cross-functional collaboration

Education

PhD/PharmD/MD

MS in Toxicology or related

Bachelor's in life sciences

Tools

OECD Toolbox

Toxtree

Benchmark Dose software

Job description

Amgen is seeking a Scientific Director, Product Stewardship Toxicology, to provide strategic scientific leadership within EHSS. You will guide toxicology programs across development, manufacturing, and lifecycle management to ensure patient and worker safety and regulatory compliance.

The role requires deep expertise in pharmaceutical toxicology, occupational toxicology, and extractables/leachables, with strong leadership and collaboration across functions.