Career CategoryScientific
Job DescriptionSr. Principal Scientist - Project ToxicologistWhat you will doLet'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
Senior 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.
- Participate in licensing, due diligence, and external partnering activities, as appropriate.
- 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 youWe 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 3 years of experience as project team representative (PTR) for nonclinical safety sciences within drug development teams
Or
Master's degree and 6 years of PTR experience
OrBachelor's degree and 8 years of PTR experience
Preferred Qualifications:- 8+ years post-PhD degree of Pharmaceutical and/or Biotechnology industry experience, including 5+ years as a Toxicologist/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.
- Board certification in Toxicology.
- 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.
• Emerging or developed recognition as a national and/or international field expert.- 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 usAs 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.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn 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.
Application deadlineAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
SponsorshipSponsorship for this role is not guaranteed.
