Sr. Principal Scientist - Project Toxicologist
Amgen
5 hours ago
Remote friendly (United States)
United States
Clinical Research and Development
Sr. Principal Scientist - Project Toxicologist
Key Responsibilities:
- Serve as a core toxicology and nonclinical safety representative on project teams, providing scientific leadership and regular updates to teams and management.
- Design, implement, manage, and interpret nonclinical safety assessment programs supporting drug development candidates.
- Originate novel study designs and protocols; develop integrated strategies to achieve project goals.
- Critically evaluate and interpret experimental data; author key sections of internal governance documents and regulatory documents (INDs, BLAs, NDAs).
- Coordinate and collaborate with internal scientists and external partners to advance R&D programs.
- Participate in licensing, due diligence, and external partnering activities, as appropriate.
- Mentor and support other scientists in design, execution, and oversight of nonclinical studies.
- Represent Amgen on nonclinical safety topics with U.S. and international regulatory agencies; contribute to external industry initiatives.
Basic Qualifications:
- Doctorate (PhD OR PharmD OR MD) plus 3 years of experience as a Project Team Representative (PTR) for nonclinical safety sciences within drug development teams
OR
- Master’s degree plus 6 years of PTR experience
OR
- Bachelor’s degree plus 8 years of PTR experience
Preferred Qualifications:
- 8+ years post-PhD industry experience in Pharmaceutical and/or Biotechnology, including 5+ years as a Toxicologist/Nonclinical Safety PTR.
- Demonstrated leadership of toxicology programs supporting nonclinical safety assessment.
- Extensive experience authoring regulatory documents and interacting with U.S. and international regulatory agencies.
- Board certification in Toxicology.
- Excellent written/verbal communication; ability to work independently and build cross-functional collaborations.
- Working knowledge of emerging science/technologies to enhance drug development safety investigations.
- Recognition as a national/international field expert.
- Demonstrated PTR experience for nonclinical safety sciences, including contributions to IND/CTA filings and nonclinical development activities.
- Strong cross-functional understanding; ability to develop integrated, fit-for-purpose plans.
- Proven experience working effectively in a matrixed organization.
Benefits (as stated):
- Comprehensive employee benefits package including Retirement and Savings Plan, group medical/dental/vision, life and disability insurance, and flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive plan for field sales roles).
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models where possible.
Application Instructions:
- Apply now via careers.amgen.com. No application deadline; applications will be accepted until a sufficient number are received or a candidate is selected.
Key Responsibilities:
- Serve as a core toxicology and nonclinical safety representative on project teams, providing scientific leadership and regular updates to teams and management.
- Design, implement, manage, and interpret nonclinical safety assessment programs supporting drug development candidates.
- Originate novel study designs and protocols; develop integrated strategies to achieve project goals.
- Critically evaluate and interpret experimental data; author key sections of internal governance documents and regulatory documents (INDs, BLAs, NDAs).
- Coordinate and collaborate with internal scientists and external partners to advance R&D programs.
- Participate in licensing, due diligence, and external partnering activities, as appropriate.
- Mentor and support other scientists in design, execution, and oversight of nonclinical studies.
- Represent Amgen on nonclinical safety topics with U.S. and international regulatory agencies; contribute to external industry initiatives.
Basic Qualifications:
- Doctorate (PhD OR PharmD OR MD) plus 3 years of experience as a Project Team Representative (PTR) for nonclinical safety sciences within drug development teams
OR
- Master’s degree plus 6 years of PTR experience
OR
- Bachelor’s degree plus 8 years of PTR experience
Preferred Qualifications:
- 8+ years post-PhD industry experience in Pharmaceutical and/or Biotechnology, including 5+ years as a Toxicologist/Nonclinical Safety PTR.
- Demonstrated leadership of toxicology programs supporting nonclinical safety assessment.
- Extensive experience authoring regulatory documents and interacting with U.S. and international regulatory agencies.
- Board certification in Toxicology.
- Excellent written/verbal communication; ability to work independently and build cross-functional collaborations.
- Working knowledge of emerging science/technologies to enhance drug development safety investigations.
- Recognition as a national/international field expert.
- Demonstrated PTR experience for nonclinical safety sciences, including contributions to IND/CTA filings and nonclinical development activities.
- Strong cross-functional understanding; ability to develop integrated, fit-for-purpose plans.
- Proven experience working effectively in a matrixed organization.
Benefits (as stated):
- Comprehensive employee benefits package including Retirement and Savings Plan, group medical/dental/vision, life and disability insurance, and flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive plan for field sales roles).
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models where possible.
Application Instructions:
- Apply now via careers.amgen.com. No application deadline; applications will be accepted until a sufficient number are received or a candidate is selected.