The Senior Clinical Project Manager is responsible for the strategic planning, implementation and management of multiple smaller studies or larger complex clinical trials across indications or programs.
The Principal Scientist, Toxicology assesses preclinical safety of experimental compounds and supports drug development programs - from lead identification through clinical trial support - in a collaborative team environment, playing a pivotal role at all levels of preclinical development.
The Principal Scientist has direct responsibility for the development of robust, safe, and cost effective chemical processes for the scale-up and manufacture of active pharmaceutical ingredients (APIs).
This position will primarily be responsible for leading CMC regulatory strategy development/execution and regulatory submission management for early development through late-stage (phase 3, registration, post-approval) programs and based on U.S. and International requirements as defined in FDA, EMA, and other HA.
Conduct enzymatic assays and in vitro/ex vivo drug metabolism studies, including liver microsome stability testing in different species, cytochrome P450 inhibition, hepatocyte metabolism, and metabolite identification, etc.
The Associate Director (AD), Clinical Operations is responsible for the strategic planning, oversight and execution of Ph1/II/III studies across indications or programs. The AD of Clinical Operations will have program oversight responsibilities while also managing a study or studies.
The Director of Clinical Research will work in a matrix organization across Preclinical, Clinical Operations, Regulatory, and Biometrics teams to ensure fully harmonized and integrated development strategies.