Senior Principal Scientist – Project Toxicologist
Amgen
full-time
Posted on:
Location Type: Remote
Location: United States
Visit company websiteExplore more
Salary
💰 $168,392 - $227,825 per year
Job Level
About the role
- 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
- 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
- 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.
Applicant 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