Senior Principal Scientist – Project Toxicologist
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Sr. Principal Scientist leading toxicology projects for drug development at Amgen. Collaborating with cross-functional teams to ensure nonclinical safety in innovative therapeutics.
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 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.
Similar Jobs
Senior Researcher, Suicide Prevention and Safety Outcomes
Senior Researcher for American Institutes for Research managing research projects in suicide prevention. Collaborating with various stakeholders to improve safety outcomes in communities and military contexts.
Research Fellow, Intern
Research Fellow at eClinicalWorks analyzing healthcare data and preparing manuscripts for peer-reviewed journals. Collaborating with industry leaders and academia in health service research and data science.
Research Scientist
Research Scientist conducting independent research in substance misuse and child wellbeing at The Ohio State University. Develops proposals, publishes findings, and mentors students.
Senior Researcher, Education Systems & Policy – Part-Time
Part-Time Senior Researcher supporting K-12 education accountability systems and evaluations. Engaging with stakeholders and managing complex policy analysis projects within the research team.
Machine Learning Research Scientist
Machine Learning Research Scientist at GroupSolver working on NLP models to enhance traditional market research practices. Collaborating with teams across different time zones to deliver insights for leading companies.
Principal Scientist, Radiopharmaceutical Therapy
Principal Scientist providing scientific input on clinical trials for medical imaging and clinical data. Leading document development, training, and project aspects in the biopharmaceutical field.
Senior Applied Scientist - Research, cMMM
Senior Applied Scientist developing the Haus Causal MMM product with a focus on innovative methodologies. Collaborating across teams to produce high-quality experiences based on causal inference and marketing measurement.
Research Assistant, Computer Science
Research Assistant at CMU's Human-Computer Interaction Institute conducting media analysis on workplace surveillance. Collaborating on data collection and case documentation in a remote setting.
Research Scientist II
Research Scientist managing technical equipment and supporting scientific research at Antarctic field stations. Working with diverse teams and ensuring operational success in extreme environments.
Research Assistant, Part Time
Research Assistant conducting UUV experimental research for the Naval Postgraduate School. Collaborating on hands-on laboratory and field work in a government research environment.
Staff Applied Scientist
Staff Applied Scientist at Lime leading technical strategy for vehicle perception. Tackling complex Computer Vision and Machine Learning challenges in micromobility applications with a global impact.
Staff Applied Scientist
Staff Applied Scientist at Lime focusing on advanced computer vision and machine learning solutions. Leading technical strategy and overseeing vision technology lifecycle in micromobility.
Education Finance Research Assistant Intern – Bachelor's Students
Education Finance Research Assistant Intern at AIR supporting research on state education finance. Collaborating on data analysis and project deliverables in a flexible remote role.
Research Assistant – Chemical Engineering
Part-time Research Assistant in Carnegie Mellon University's Chemical Engineering Department. Engaging in data analysis, application development, and supporting research objectives within the Laird lab.
Senior Applied Scientist, Agentic AI
Senior Applied Scientist developing LLM-powered reasoning systems for real estate applications at Zillow. Focusing on advanced reasoning and agentic capabilities in real estate use cases.
Applied Scientist II – Audio
Applied Scientist II focusing on audio deepfake detection models at Reality Defender, advancing cybersecurity with cutting-edge technology. Collaborate with teams to ensure model performance in real-world scenarios.
Senior Principal Scientist – Antibody-siRNA Bioanalytical, Biodistribution Strategy Lead
Senior Principal Scientist leading bioanalytical and biodistribution strategies for antibody-siRNA conjugates. Collaborating with multidisciplinary teams to support clinical candidate selection.
Senior Applied Scientist
Senior Applied Scientist developing proprietary models for corporate ownership and trade networks at Sayari. Collaborating with AI/ML engineers to shape data strategies and deployment processes.
Senior Researcher
Senior Researcher at Pureprofile managing Quantitative and Qualitative research projects while collaborating with Client Solutions/Sales team for actionable insights.
Decision Research Scientist
Decision Research Scientist advancing decision intelligence at Rwazi through structured reasoning and applied methodologies remotely. Collaborating across teams to enhance decision-making capabilities.