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 patients with liver fibrosis stage 4 (F4) and compensated cirrhosis due to 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), and the drug candidate NGM120 is in a Phase 1/2 study for the treatment of advanced solid tumors and pancreatic cancer. NGM’s strategic collaboration with Merck, with a current term running to March 2024, focuses primarily on the development of novel medicines for unmet patient needs in retinal and CVM diseases, and provides us with the resources and flexibility to pursue our ambitious R&D goals and further extend our pipeline of novel drug candidates.
We are seeking an experienced nonclinical project toxicologist to work in a team-based environment and join new and ongoing project teams. The candidate will serve as the nonclinical toxicologist working across discovery and development teams in a variety of disease areas. nonclinical toxicology and investigational safety studies at different stages of development, including exploratory, pilot, and pivotal studies. The toxicologist will review protocols, data, and study reports ensuring accurate presentation and interpretation of data in the context of the literature and project goals and contribute to regulatory documents to support global filings. Qualified Toxicologists will present results to project team and department meetings. Strong candidates will exhibit the ability to manage multiple projects simultaneously, and possess a basic understanding of regulatory guidance impacting drug development. Knowledge and understanding of GLPs and of regulatory requirements, including ICH requirements and other regional requirements, is also strongly desired.
- Serve as noncincial toxicologist in the project team and conducts toxicology safety assessment activities related to drug discovery, drug development, and regulatory, in research and development teams.
- Contributes to the design and assists in implementation of safety studies in collaboration with CROs
- Manage collaborations with study directors to support writing of study protocols, amendments, and study reports for non-GLP and GLP studies
- Analyze, interpret, summarize, and present nonclinical safety data, both interim and final to internal teams and department
- Contribute to investigative efforts into mechanisms of toxicity as needed
- Develop and implement target de-risking and screening strategies in discovery teams to support safety lead optimization efforts.
- Contributes to the authoring of toxicology and safety pharmacology sections of global regulatory documents (INDs, NDAs, BLAs and CTDs)
- PhD in Toxicology or a related scientific discipline or equivalent with 3+ years of relevant technical experience in Toxicology in the Pharmaceutical Industry and/or drug development
- Prior experience with protein therapeutics preferred
- Hands-on experience in designing and monitoring non-GLP and GLP toxicology studies, as well as data interpretation.
- Knowledge of preclinical drug development and regulatory filing documents, including authoring and review of relevant sections of regulatory submissions (e.g. INDs, NDAs, BLAs) is required.
- Strong written, verbal, and interpersonal communications skills including ability to communicate scientific information clearly and effectively
- Ability to work independently and direct day to day responsibilities supporting safety studies
- Demonstrated ability to work effectively with cross-functional groups and external partners/CROs in a matrix team environment.
- A team player with excellent verbal and written communication skills
- Proficient in relevant software & computer skills
- Proven flexibility to deal with changing timelines, shifting work priorities
NGM offers a creative, collaborative, highly challenging scientific environment, along with a strong compensation package that includes salary, stock options, employee stock purchase program participation, 401(k) and a comprehensive, industry-leading, benefits package.
Qualified candidates please apply directly at link below.