Sr. Principal Scientist Project Toxicologist

Career Category

Job Description

Join Amgens Mission of Serving Patients

At 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.

Sr. Principal Scientist - Project Toxicologist

What you will do

Lets do this. Lets change the 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 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 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.
• 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 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 3 years of experience as project team representative (PTR) for nonclinical safety sciences within drug development teams

Or

Masters degree and 6 years of PTR experience

Or

Bachelors 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 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.

Apply now and make a lasting impact with the Amgen team.

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.

Application deadline

Amgen 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.

Sponsorship

Sponsorship for this role is not guaranteed.

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.

Salary Range