Sr. Principal Scientist - Project Toxicologist

Join Amgen's mission of serving patients. At Amgen, you are part of something bigger, and our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we have helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on oncology, inflammation, general medicine, and rare disease, we reach millions of patients each year. As a member of the Amgen team, you help make a lasting impact on the lives of patients by researching, manufacturing, and delivering innovative medicines to help people live longer, fuller, happier lives.

Sr. Principal Scientist - Project Toxicologist

Let’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 non‑clinical 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 non‑clinical safety (e.g. organ/system‑specific toxicity).

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 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 You

The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications

• Doctorate degree (PhD, PharmD or MD) and 3 years of experience as a PTR for nonclinical safety sciences within drug development teams.
• OR Masters degree and 6 years of PTR experience.
• OR Bachelors degree and 8 years of PTR experience.

Preferred 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 a PTR 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 therapeutics.
• Proven experience working effectively in a matrixed organization, with strong communication and interpersonal skills.

What You Can Expect Of Us

From our competitive benefits to our collaborative culture, we support your professional and personal growth and well‑being. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills, experience, and qualifications.

In addition to base salary, Amgen offers a total rewards plan, comprising:

• A comprehensive employee benefits package, including retirement and savings plans with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program (and for field sales representatives, a sales‑based incentive plan).
• Stock‑based long‑term incentives.
• Award‑winning time‑off plans.
• Flexible work models where possible.

Application

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship for this role is not guaranteed.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.