Principal Scientist, Project Toxicologist

Amgen SA; Northern (KY); Hybrid; USD 150,000 - 230,000; Full time

Benefits offered by this job

Flexible work model

Competitive benefits

Job summary

Amgen is seeking a Principal Scientist - Project Toxicologist to lead nonclinical safety strategies across multiple therapeutic modalities, interfacing with Translational Safety & Risk Sciences and cross-functional teams from discovery through post-marketing. The role emphasizes scientific leadership, project oversight, and regulatory communication.

The candidate will develop fit-for-purpose safety strategies, adapt to new data, and mentor junior scientists while ensuring alignment with

Qualifications

• Doctorate degree (PhD OR PharmD OR MD) and 2 years PTR experience in nonclinical safety within drug development.
• Master’s degree and 5 years PTR experience.
• Bachelor’s degree and 7 years PTR experience.

Responsibilities

• Serve as a core toxicology and nonclinical safety representative on project teams.
• Design, implement and manage nonclinical safety programs for drug development candidates.
• Originate study designs and protocols for complex toxicology questions.
• Author sections of regulatory documents (INDs/BLAs/NDAs) and other filings.
• Coordinate with internal Amgen scientists and external partners to advance programs.
• Mentor other Amgen scientists in nonclinical safety studies oversight.
• Represent Amgen in regulatory discussions and industry initiatives.

Skills

Leadership

Regulatory writing

Cross-functional collaboration

Communication

Education

Doctorate degree (PhD)

Master’s degree

Bachelor’s degree

Job description

Join Amgen’s Mission of Serving Patients

At 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.

Principal Scientist - Project Toxicologist

What you will do

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 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 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.
• 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

We 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 2 years of experience as project team representative (PTR) for nonclinical safety sciences within drug development teams

Or

Master’s degree and 5 years of PTR experience

Or

Bachelor’s degree and 7 years of PTR experience

Preferred Qualifications:

• 6+ years post-PhD degree of Pharmaceutical and/or Biotechnology industry experience and 4+ years as 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.
• 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.
• 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.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

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 the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• 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, and 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. Refer to the Work Location Type in the job posting to see if this applies.

At Amgen, our mission is to serve patients by advancing science to improve the quality of life for people around the world. We are committed to fostering an inclusive and ethical workplace made up of diverse, talented, and highly accomplished individuals who respect one another and live the Amgen values. Together, we compete every day to make a meaningful impact in the fight against serious disease.

Amgen is an equal opportunity employer and considers all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other characteristic protected by applicable law.

Amgen is committed to providing reasonable accommodations to individuals with disabilities to ensure participation in the application and interview process, the performance of essential job functions, and equal access to employment benefits and privileges. Applicants may request accommodation as needed.