Scientific Associate Director - Project Toxicologist

BioSpace; Washington (District of Columbia); On-site; USD 190,000 - 270,000; Full time

Benefits offered by this job

Remote and hybrid work options

Discretionary annual bonus

Stock-based long-term incentives

Retirement and savings plan

Job summary

Amgen in the United States is seeking a Scientific Associate Director - Project Toxicologist to lead nonclinical safety strategies across discovery to marketed products. You will serve as the TSRS PTR on core project teams, design studies, interpret data, and contribute to regulatory submissions, with opportunities to mentor scientists and collaborate with partners.

The role emphasizes cross-functional leadership, innovative NAMs approaches, and a commitment to translating safety science into

Qualifications

• Doctorate in relevant field with toxicology experience.
• Experience leading nonclinical safety programs.
• Ability to interpret data for regulatory submissions.
• Strong communication and cross-functional collaboration.

Responsibilities

• Represent TSRS on core project teams and lead sub-teams.
• Design and oversee nonclinical safety programs for development candidates.
• Develop study designs and NAMs-based risk assessments.
• Interpret data and contribute to regulatory submissions.
• Collaborate with internal and external partners.
• Mentor scientists in nonclinical studies.

Skills

Toxicology expertise

Cross-functional leadership

Regulatory submissions

Project management

NAMs knowledge

Education

PhD, PharmD, or MD

Masters degree

Bachelors degree

Job description

Scientific Associate Director - Project Toxicologist

What you will do

Lets do this. Lets 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.

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
• Masters degree and 7 years of Toxicology experience
• Bachelors 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

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 well 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 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, including remote and hybrid work arrangements, where possible

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

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.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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.