Principal Scientist PKDM (Large Molecule Project Team Representative)

Career Category Scientific 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 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 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, 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.com 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. Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance. Salary Range 163,670.05USD -221,435.95 USD Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen