Scientific Associate Director - Project Toxicologist

Amgen; United States; Hybrid; USD 194,000 - 263,000; Full time

Benefits offered by this job

Retirement plan

Medical/dental/vision coverage

Stock-based incentives

Flexible time off

Remote/hybrid options

Job summary

Amgen is seeking a Scientific Associate Director - Project Toxicologist to serve as the key scientific interface between Translational Safety & Risk Sciences (TSRS) and cross-functional project teams from discovery through post-marketing. The role leads nonclinical safety strategies and coordinates multidisciplinary teams to drive human risk assessment and informed development decisions.

The position requires leadership across modalities including biologics and small molecules, with emphasis on

Qualifications

• PhD/MD/PharmD with at least 4 years of toxicology experience.
• Master’s degree with at least 7 years of toxicology experience.
• Bachelor’s degree with at least 9 years of toxicology experience.

Responsibilities

• Lead TSRS PTR on core project teams and coordinate the TSRS sub-team.
• Drive translational safety strategy and inform human risk with precision, insight and impact.
• Design, oversee and interpret nonclinical safety programs for development candidates.
• Mentor scientists in nonclinical study design, execution, and oversight.

Education

Doctorate degree (PhD, PharmD, or MD)

Master’s degree

Bachelor’s degree

Job description

Career Category Scientific 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.

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.g. 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.

Basic Qualifications

• Doctorate degree (PhD, PharmD, or MD) and 4 years of Toxicology experience
• 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.g. 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 ability to influence a broad spectrum of partners toward achieving business goals
• External visibility as a toxicology subject matter expert, demonstrated by external presentations and publications and/or leadership or active participation in external collaborative groups

What you can expect of us

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.

Salary Range 194,274.30USD -262,841.70 USD

• 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, including remote and hybrid work arrangements, where possible

Sponsorship

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

Sponsorship for this role is not guaranteed.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Equal Opportunity employer and EEO statement

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.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen