Principal Scientist, Project Toxicologist

BioSpace; Washington (District of Columbia); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical, Dental, Vision

Life and Disability Insurance

Flexible Spending Accounts

Discretionary Bonus

Stock-based incentives

Flexible work model

Job summary

Amgen is seeking a Principal Scientist - Project Toxicologist to serve as the primary interface between Translational Safety & Risk Sciences and cross-functional project teams from discovery through post-marketing. You will develop nonclinical safety strategies, lead multidisciplinary teams, and collaborate with internal and external partners to advance drug development programs across modalities.

The role requires extensive experience in nonclinical safety, regulatory interactions, and

Qualifications

• Doctorate or equivalent with 2+ years as PTR for nonclinical safety
• Masters with 5+ years PTR experience
• Bachelor's with 7 years PTR experience
• 6+ years post-PhD in pharma/biotech with 4+ years as Nonclinical Safety PTR
• Experience leading toxicology programs and regulatory interactions
• Strong written and verbal communication; ability to work independently in a cross-functional environment

Responsibilities

• Serve as core toxicology and nonclinical safety lead on project teams
• Design and oversee nonclinical safety assessment programs
• Develop innovative, fit-for-purpose safety strategies
• Mentor other Amgen scientists in study oversight
• Represent Amgen with regulatory agencies

Skills

Leadership

Cross-functional collaboration

Regulatory interaction

Nonclinical safety

Toxicology

Education

PhD/PharmD/MD

Masters with PTR

Bachelors with PTR

Job description

Join Amgens Mission of Serving PatientsAt Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll 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

Lets do this. Lets change the world. In this vital role, you will serve as the primary interface between Translational Safety & Risk Sciences (TSRS) and crossfunctional 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 modalitiesincluding 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

Masters degree and 5 years of PTR experience

Or

Bachelors 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, 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 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.

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.

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.