Principal Scientist – PKDM (Large Molecule Project Team Representative)

Amgen•South San Francisco, CA

30d•$163,670 - $221,436

About The Position

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.

Requirements

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

Nice To Haves

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

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

Benefits

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

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