Principal Scientist – PKDM (Large Molecule Project Team Representative)

Career Category

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

Principal Scientist – PKDM (Large Molecule Project Team Representative)

What you will do

Let’s do this. Let’s change the world. In this vital role you will serve as a Pharmacokinetics and Drug Metabolism – Bioanalytical (PKDM-BA) Project Team Representative (PTR) supporting large molecule discovery and early development programs. You will work cross-functionally to characterize the absorption, distribution, metabolism, excretion (ADME), and pharmacokinetic/pharmacodynamic (PK/PD) properties of biologic therapeutics to advance programs from discovery through candidate selection and development.

You will provide strategic and scientific leadership across multidisciplinary project teams while partnering closely with experts in pharmacology, toxicology, protein sciences, medicinal chemistry, pharmaceutical sciences, clinical pharmacology, and regulatory sciences.

Key Responsibilities:

• Serving as the PKDM-BA functional representative and subject matter expert for large molecule therapeutic programs
• Designing and executing translational PK/PD and mechanistic ADME strategies to support progression of biologic therapeutics including monoclonal antibodies, bispecifics, multispecifics, antibody conjugates, peptides, oligonucleotide conjugates, and other emerging modalities
• Leading team discussions around pharmacokinetics, biodistribution, target-mediated disposition, tractability, and differentiation strategies
• Designing, coordinating, and interpreting in vitro and in vivo studies to characterize exposure, disposition, clearance mechanisms, and pharmacologic activity
• Partnering with PKDM-BA scientists, in vivo teams, and subject matter experts to execute program strategies and forecast project needs
• Driving hypothesis-based scientific decision-making and contributing to program strategy across discovery and development teams
• Providing scientific leadership for preclinical PKDM components of regulatory submissions including support for IND-enabling activities, nonclinical summaries, and pharmacokinetic written summaries
• Communicating project strategy, data interpretation, risks, timelines, and resource needs to project teams and PKDM leadership
• Building strong cross-functional relationships across therapeutic areas and Research & Development functions
• Mentoring junior scientists and contributing to scientific excellence across the PKDM organization
• Contributing to external scientific visibility through publications, presentations, and participation in scientific conferences and consortia

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 scientific leader [type of person] with these qualifications.

Basic Qualifications:

Doctorate degree PhD

OR

PharmD

OR

MD [and relevant post-doctoral training where applicable] and 3 years of directly related experience

OR

Master’s degree and 6 years of directly related experience

OR

Bachelor’s degree and 8 years of directly related experience

Preferred Qualifications:

• PhD in Pharmacokinetics, Pharmaceutical Sciences, Biochemistry, Pharmacology, Bioengineering, Immunology, or related scientific discipline
• Strong background in biologics drug discovery and development with expertise in large molecule ADME and pharmacokinetics
• Experience serving as a functional project team representative for discovery and/or development programs