Sr. Principal Scientist - Project Toxicologist

Career CategoryScientificJob DescriptionJoin Amgen’s Mission of Serving PatientsAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Sr. Principal Scientist - Project ToxicologistWhat you will doLet’s do this. Let’s change the world. In this vital role, you will serve as the primary interface between Translational Safety & Risk Sciences (TSRS) and cross‑functional project teams, from early discovery through post-marketing. TSRS at Amgen is seeking a Senior Principal Scientist to serve as a Project Toxicologist and Subject Matter Expert, reporting to a Project Team Representative (PTR) Manager.You will be responsible for developing and implementing fit-for-purpose nonclinical safety strategies built on a rigorous scientific foundation and aligned with regulatory expectations. As programs evolve, you will flexibly adapt strategies in response to emerging data, and project team needs while leading multidisciplinary TSRS teams.As a PTR, you will partner closely with project teams developing innovative therapeutics across a range of modalities—including biotherapeutics (e.g. T cell engagers and antibody-drug conjugates), small molecules, targeted protein degraders, and other complex modalities (e.g. RNA-based therapies) for indications in inflammation, rare diseases, oncology, and cardiometabolic diseases, including obesity. PTRs are encouraged to develop subject matter expertise in a specific modality, therapeutic area, or sub-discipline within nonclinical safety (e.g. organ/system-specific toxicity).Key ResponsibilitiesServe 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.What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.Basic Qualifications:Doctorate degree PhD OR PharmD OR MD and 3 years of experience as project team representative (PTR) for nonclinical safety sciences within drug development teamsOrMaster’s degree and 6 years of PTR experienceOrBachelor’s degree and 8 years of PTR experiencePreferred Qualifications: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