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About the role
Key responsibilities & impact- 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 in support of drug development candidates.
- Originate novel study designs and protocols to address complex scientific questions and develop integrated strategies to achieve project goals.
- Critically evaluate and interpret experimental data and author key sections of internal governance documents, INDs, BLAs, NDAs and other regulatory documents.
- Coordinate and collaborate with internal Amgen scientists and external partners to advance research and development programs.
- Participate in licensing, due diligence, and external partnering activities, as appropriate.
- Mentor and support other Amgen scientists in the design execution and oversight of nonclinical studies.
- Represent Amgen on nonclinical safety topics in interactions with U.S. and international regulatory agencies, and contribute to external industry initiatives aimed at advancing drug safety assessment paradigms.
Requirements
What you’ll need- Doctorate degree PhD OR PharmD OR MD and 3 years of experience as project team representative (PTR) for nonclinical safety sciences within drug development teams
- Or Master’s degree and 6 years of PTR experience
- Or Bachelor’s degree and 8 years of PTR experience
- 8+ years post-PhD degree of Pharmaceutical and/or Biotechnology industry experience, including 5+ years as a Toxicologist/Nonclinical Safety Project Team Representative
- Demonstrated leadership of toxicology programs supporting nonclinical safety assessment of drug development candidates.
- Extensive experience authoring regulatory documents and interacting with U.S. and international regulatory agencies.
- Board certification in Toxicology.
- Excellent written and verbal communication skills, with the ability to work independently and build productive cross-functional collaborations both internally and externally.
- Working knowledge of emerging science and technologies applied to enhance investigation of drug development safety issues.
- Emerging or developed recognition as a national and/or international field expert.
- Demonstrated experience serving as project team representative for nonclinical safety sciences within drug development teams, including contributing to IND/CTA filings and broader nonclinical development activities.
- A strong understanding of cross-functional needs is essential, along with the ability to develop integrated, fit-for-purpose plans that enable successful development of a therapeutics.
- Proven experience working effectively in matrixed organization, with strong communication and interpersonal skills.
Benefits
Comp & perks- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- group medical, dental and vision coverage
- life and disability insurance
- flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
toxicologynonclinical safety assessmentdrug developmentregulatory document authoringINDsBLAsNDAsstudy designdata interpretationproject team representation
Soft Skills
scientific leadershipcommunication skillscollaborationmentoringindependencecross-functional collaborationorganizational skillsproblem-solvinginterpersonal skillsstrategic planning
Certifications
PhDPharmDMDboard certification in Toxicology