Clinical Pharmacology, PK/PD
NGM Biopharmaceuticals, Inc. is a biopharmaceutical company dedicated to discovering and developing the next generation of medicines for the treatment of serious diseases. Our experienced scientific team has joined forces with an impressive group of industry professionals, Nobel Laureates and other distinguished researchers to build a company where innovation and cutting-edge science has provided the foundation for a robust drug discovery engine that has a track record of generating one new IND candidate per year. NGM’s current pipeline of clinical-stage programs consists of five drug candidates targeting liver and metabolic diseases, retinal diseases and cancer. The most advanced drug candidate, aldafermin (NGM282), is in Phase 2b clinical studies in non-alcoholic steatohepatitis (NASH) and is wholly-owned by NGM. Another drug candidate, NGM621, is in a Phase 2 study in geographic atrophy (GA) secondary to age-related macular degeneration (AMD). NGM’s strategic collaboration with Merck, with a current term running to March 2022, provides us with the resources and flexibility to pursue our ambitious R&D goals and further extend our pipeline of novel drug candidates.
- Responsible for the design and data analysis/interpretation of pharmacokinetic (PK), toxicokinetic and pharmacodynamics (PD) aspects of preclinical and clinical studies
- Represent PKPD on cross-functional research and early development project teams to support drug candidate nominations and IND-enabling studies
- Interpret preclinical PK data to inform human dose projections
- Investigate the PKPD relationships of novel drug candidates by conducting or being accountable for PKPD modeling activities
- Write scientific reports and prepare documents for PKPD-related sections in Investigator Brochures, study reports, manuscripts, summaries for regulatory authorities, INDs and BLAs
- Participate and present PKPD findings in project team meetings
- MS or PhD degree in pharmaceutics, pharmacokinetics, pharmacology, or related discipline
- 3-12 years in the biotech/pharmaceutical industry in the area of preclinical drug discovery and/or development (level commensurate with experience)
- Experience in the conduct, analysis and interpretation of in vivo preclinical pharmacokinetic studies
- Experience with large molecule (proteins and monoclonal antibody) pharmacokinetics and drug development preferred
- Experience with PKPD model development and human dose projections preferred
- Must be detail-oriented with strong documentation and organizational skills
- Excellent interpersonal skills, ability to work in a matrix environment and develop relationships with key stakeholders
- Excellent communication and presentation skills to efficiently relay information to project teams and other key stakeholders
- Strong research background and interest in understanding PK data in the context of complex biology
- Proven ability to work independently and be self-motivated
Interested applicants should click Apply
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