Scientific Associate Director - Project Toxicologist

Career Category
Scientific

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.

Scientific Associate Director - Project Toxicologist
What you will do

Let's do this.
Let's change the world.
In this vital role, you will serve as the key scientific interface between Translational Safety & Risk Sciences (TSRS) and cross-functional project teams from discovery through post-marketing.
TSRS is seeking a Scientific Associate Director to serve as a Project Toxicologist and subject matter expert, reporting to a Senior Director 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, 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.
drug-induced liver toxicity).

Key Responsibilities
Serve as TSRS PTR (nonclinical safety representative) on core project teams and lead the TSRS sub-team.
The TSRS PTR is a key ambassador for the TSRS mission:
Driving translational safety strategy and innovation to inform human risk with precision, insight, and impact, accelerating transformative therapies to patients.

Lead and coordinate the TSRS sub-team, fully leveraging the TSRS advisory network to inform human risk assessment, shape development strategy, and enable confident project decisions.

Design, implement, oversee, and interpret nonclinical safety assessment programs supporting drug development candidates with an enterprise-wide mindset.

Develop innovative study designs and nonclinical assessment strategies to address complex scientific questions, integrating AI-enabled approaches and New Approach Methodologies (NAMs) to enhance translational risk assessment and support critical development decisions.

Critically evaluate and interpret experimental data and author key sections of nonclinical strategy, governance and regulatory submissions, including first-in human trial applications and marketing authorizations.

Communicate effectively, both orally and in writing, within TSRS and across core project teams, leadership, governance bodies, and regulatory agencies, tailoring communications to the needs and expertise of diverse audiences.

Operate effectively in a fast-paced, highly matrixed environment, balancing the needs of multiple project teams and stakeholders while ensuring proactive communication, strategic prioritization, and timely delivery of TSRS contributions.

Collaborate closely with internal Amgen scientists and external partners to advance research and development programs.

Contribute to business development activities, including licensing evaluations, due diligence assessments, and external partnerships, as appropriate.

Mentor and support fellow scientists in the design, execution, interpretation, and oversight of nonclinical studies and development programs.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.
The scientific leader we seek is collaborative, strategic, and comfortable influencing across multidisciplinary teams, with these qualifications.

Basic Qualifications:

Doctorate degree (PhD, PharmD, or MD) and 4 years of Toxicology experience
Or

Master's degree and 7 years of Toxicology experience

Bachelor's degree and 9 years of Toxicology experience

Preferred Qualifications:

A minimum of 8 years of drug development experience as a Project Toxicologist/Nonclinical Safety Project Team Representative at all stages of development including late-stage assets and interactions with global regulatory agencies for first-in human trial applications and marketing authorizations.

End-to-end small- and large-molecule safety assessment experience across multiple therapeutic areas and modalities
Preferred experience in nonclinical safety assessment of siRNA therapeutics, antibody-drug conjugates (ADCs), antibody-peptide conjugates, and/or targeted protein degraders
Demonstrate a proven ability to serve as a highly effective cross-functional thought partner, driving alignment and advancing complex scientific discussions across R&D functions
Subject matter expertise in a defined area of toxicology (e.
drug-induced liver injury)
Experience supporting business development efforts through due diligence evaluations as a translational safety team member
Scientific leader with matrixed management experience
Board certification by the American Board of Toxicology
Excellent communicator with a proven abi.