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.
NGM is seeking an Associate Director with drug development and regulatory submission experience, and a proven ability to contribute to the understanding of the pharmacologic / toxicologic mechanisms of drug-induced responses. Qualified candidates must have a solid understanding of regulatory toxicology and understand complex biologic pathways across multiple therapeutic programs, identify key research activities of importance, be detail-oriented, and possess strong documentation and organizational skills. Industry experience designing and monitoring in-house and CRO-run toxicology studies and study monitoring required.
- Key member / lead on multidisciplinary Product Development Teams representing the toxicology function; help define and implement nonclinical safety evaluation strategy and development plan for novel candidate molecules.
- Experience participating in / leading Research Project Teams to evaluate potential safety and toxicity liabilities of biologic pathways of interest.
- Proven ability to lead study design and execution to help inform the potential translatability and relevance of nonclinical safety findings to humans / clinic.
- Responsible for drafting and reviewing pertinent sections of regulatory documents (IND, BLA, IMPD, IB, briefing packages) including nonclinical pharmacology and toxicology.
- Design and manage toxicology studies in-house and at contract research organizations (CROs).
- Minimum 8+ years of experience in the biotech/pharmaceutical industry in nonclinical or preclinical drug discovery and/or development (title commensurate with experience).
- PhD degree in toxicology, pathology, pharmacology, or related discipline; comparable doctorate will be considered.
- Post-doctoral experience preferred.
- Experience with large molecule (proteins and monoclonal antibody) drug discovery and development strongly desired.
- 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
- Proven ability to work independently and self-motivate
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.