Principal Scientist – PKDM (Large Molecule Project Team Representative)
Amgen
17 days ago
Remote friendly (United States)
United States
Clinical Research and Development
Principal Scientist – PKDM (Large Molecule Project Team Representative)
What You Will Do
Serve as Pharmacokinetics and Drug Metabolism – Bioanalytical (PKDM-BA) Project Team Representative (PTR) supporting large molecule discovery and early development. Characterize absorption, distribution, metabolism, excretion (ADME), and pharmacokinetic/pharmacodynamic (PK/PD) properties of biologic therapeutics to advance programs from discovery through candidate selection and development. Provide strategic/scientific leadership across multidisciplinary teams.
Key Responsibilities
- Serve as PKDM-BA functional representative and subject matter expert for large molecule therapeutic programs
- Design and execute translational PK/PD and mechanistic ADME strategies for biologic modalities (mAbs, bispecifics, multispecifics, conjugates, peptides, oligonucleotide conjugates, emerging modalities)
- Lead discussions on pharmacokinetics, biodistribution, target-mediated disposition, tractability, and differentiation
- Design, coordinate, and interpret in vitro/in vivo studies to characterize exposure, disposition, clearance mechanisms, and pharmacologic activity
- Partner to execute program strategies and forecast project needs
- Drive hypothesis-based scientific decision-making across discovery/development
- Provide scientific leadership for preclinical PKDM components of regulatory submissions (IND-enabling support, nonclinical summaries, pharmacokinetic written summaries)
- Communicate strategy, data interpretation, risks, timelines, and resources; build cross-functional relationships
- Mentor junior scientists; contribute to scientific excellence; publish/present and engage in conferences/consortia
Basic Qualifications
- PhD (or PharmD; or MD with relevant post-doctoral training and 3 years related experience; or Master’s and 6 years; or Bachelor’s and 8 years)
Preferred Qualifications
- PhD in PK/Pharmaceutical Sciences/Biochemistry/Pharmacology/Bioengineering/Immunology or related field
- Expertise in large molecule ADME and pharmacokinetics; experience as functional project team representative
- Strong preclinical PK/PD knowledge (target-mediated disposition, biodistribution)
- Experience across biologic modalities; mechanistic in vitro/in vivo PKDM study design/interpretation
- Bioanalytical understanding for biologics/complex modalities
- Regulatory submission and preclinical ADME/PK documentation experience; independent strategy and cross-functional influence
- Strong communication skills; collaborative matrix experience
- Record of scientific achievement; mentoring experience
Application Instructions
- Apply via careers.amgen.com. No application deadline; applications accepted until sufficient candidates are received or a candidate is selected.
What You Will Do
Serve as Pharmacokinetics and Drug Metabolism – Bioanalytical (PKDM-BA) Project Team Representative (PTR) supporting large molecule discovery and early development. Characterize absorption, distribution, metabolism, excretion (ADME), and pharmacokinetic/pharmacodynamic (PK/PD) properties of biologic therapeutics to advance programs from discovery through candidate selection and development. Provide strategic/scientific leadership across multidisciplinary teams.
Key Responsibilities
- Serve as PKDM-BA functional representative and subject matter expert for large molecule therapeutic programs
- Design and execute translational PK/PD and mechanistic ADME strategies for biologic modalities (mAbs, bispecifics, multispecifics, conjugates, peptides, oligonucleotide conjugates, emerging modalities)
- Lead discussions on pharmacokinetics, biodistribution, target-mediated disposition, tractability, and differentiation
- Design, coordinate, and interpret in vitro/in vivo studies to characterize exposure, disposition, clearance mechanisms, and pharmacologic activity
- Partner to execute program strategies and forecast project needs
- Drive hypothesis-based scientific decision-making across discovery/development
- Provide scientific leadership for preclinical PKDM components of regulatory submissions (IND-enabling support, nonclinical summaries, pharmacokinetic written summaries)
- Communicate strategy, data interpretation, risks, timelines, and resources; build cross-functional relationships
- Mentor junior scientists; contribute to scientific excellence; publish/present and engage in conferences/consortia
Basic Qualifications
- PhD (or PharmD; or MD with relevant post-doctoral training and 3 years related experience; or Master’s and 6 years; or Bachelor’s and 8 years)
Preferred Qualifications
- PhD in PK/Pharmaceutical Sciences/Biochemistry/Pharmacology/Bioengineering/Immunology or related field
- Expertise in large molecule ADME and pharmacokinetics; experience as functional project team representative
- Strong preclinical PK/PD knowledge (target-mediated disposition, biodistribution)
- Experience across biologic modalities; mechanistic in vitro/in vivo PKDM study design/interpretation
- Bioanalytical understanding for biologics/complex modalities
- Regulatory submission and preclinical ADME/PK documentation experience; independent strategy and cross-functional influence
- Strong communication skills; collaborative matrix experience
- Record of scientific achievement; mentoring experience
Application Instructions
- Apply via careers.amgen.com. No application deadline; applications accepted until sufficient candidates are received or a candidate is selected.