Functional area: Toxicology
The Toxicology Group provides scientific leadership and has a critical role in the drug discovery and development being conducted at Ironwood Pharmaceuticals. Ironwood is focused on three goals: transforming knowledge into medicines that make a difference for patients, creating value that will inspire the continued support of our fellow shareholders, and building a team that passionately pursues excellence.
The successful candidate is responsible for the execution of nonclinical toxicology and safety pharmacology studies to support Ironwood’s drug discovery and development goals.
Participate in nonclinical study design and protocol development for toxicology, toxicokinetic and safety pharmacology studies to support discovery and development programs;
Plan, coordinate and manage nonclinical toxicology studies, interact with study personnel and monitor ongoing toxicology studies;
Review and summarize toxicology data collected and manage the preparation and presentation of nonclinical safety data for project teams, regulatory agencies, management and in other internal and external arena;
Interact cross functionally on program teams and, as appropriate, represent the Toxicology functional area in related scientific planning and discussions;
Influence the selection of contract research organizations; assist in study cost negotiation and track all expenses and invoices; participate in preparing nonclinical budgets for discovery and development programs.
B.S., M.S. or Ph.D. with at least 2 years of experience in preclinical toxicology and drug development in the pharmaceutical/biotechnology sector
Familiarity with GLP regulations and ICH/FDA guidelines for the conduct of toxicology studies to support regulatory filings
Experience working at or with Contract Research Organizations
Strong verbal, written and interpersonal communication skills