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

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
• Deep understanding of preclinical PK/PD relationships and factors influencing large molecule disposition, including target-mediated drug disposition and biodistribution
• Experience with biologic therapeutic modalities such as monoclonal antibodies, bispecifics, multispecifics, antibody-drug conjugates, peptide conjugates, oligonucleotide therapeutics, and/or RNA-based modalities
• Experience designing and interpreting mechanistic in vitro and in vivo PKDM studies
• Understanding of bioanalytical approaches supporting biologics and complex therapeutic modalities
• Experience supporting regulatory submissions and authoring preclinical ADME/PK documentation
• Ability to independently drive scientific strategy and influence cross-functional decision-making
• Excellent written, verbal, and interpersonal communication skills
• Demonstrated ability to work effectively in a highly collaborative, matrixed research environment
• Record of scientific achievement through publications, presentations, patents, and/or external scientific engagement
• Experience mentoring scientists and contributing to organizational scientific development

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’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.

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.

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 for this role is not guaranteed.