Senior Principal Scientist — Project Toxicologist

BioSpace; Washington (District of Columbia); Hybrid; USD 210,000 - 260,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical, Dental and Vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Stock-based incentives

Generous time-off plans

Flexible work models

Job summary

Amgen is seeking a Senior Principal Scientist to serve as Project Toxicologist, leading nonclinical safety strategies across therapeutic areas. You will partner with Translational Safety & Risk Sciences, guiding cross-functional teams from discovery through post-marketing and ensuring alignment with regulatory expectations.

Applicants should have advanced PTR experience, strong leadership, and a track record of regulatory interactions.

Qualifications

• Doctorate degree (PhD/MD/PharmD) with PTR experience in nonclinical safety.
• Alternative: Master’s degree with PTR experience in drug development.
• Alternative: Bachelor's degree with PTR experience in drug development.
• Experience authoring regulatory documents and interacting with regulators.

Responsibilities

• Serve as core toxicology and nonclinical safety representative on project teams.
• Design, manage and interpret nonclinical safety assessment programs.
• Originate novel study designs to address complex scientific questions.
• Critically evaluate data and draft key governance/regulatory sections.
• Coordinate with internal/external partners to advance programs.
• Participate in licensing, due diligence, and partnering activities.
• Mentor other scientists in design, execution and oversight of nonclinical studies.
• Represent Amgen on nonclinical safety topics with regulatory agencies.

Skills

Scientific leadership

Regulatory liaison

Written communication

Verbal communication

Cross-functional collaboration

Mentorship

Strategic thinking

Education

PhD/MD/PharmD with PTR experience

Masters with PTR experience

Bachelors with PTR experience

Job description

Amgen is seeking a Senior Principal Scientist to serve as Project Toxicologist, leading nonclinical safety strategies across therapeutic areas. You will partner with Translational Safety & Risk Sciences, guiding cross-functional teams from discovery through post-marketing and ensuring alignment with regulatory expectations.

Applicants should have advanced PTR experience, strong leadership, and a track record of regulatory interactions.