Director of Toxicology
(Job Code: 8HR151)
Responsibilities/Accountabilities:
Manage toxicology group and responsible for the operation of
all toxicology / safety programs (GLP and non-GLP)
Supervise, plan, design, manage, and report nonclinical
safety / toxicology and other nonclinical studies
Coordinate, supervise, and manage contract GLP toxicology and safety
pharmacology studies
Strategize, plan, and prepare regulatory documents and submissions;
communicate and interact directly with FDA and other regulatory
agencies.
Qualifications:
Ph.D. with 8+ year in toxicology, or equivalent; DABT preferred.
Hands-on experience in managing nonclinical tox/safety programs,
including design and execution of GLP tox and safety pharmacology
studies
Experience in small molecule and/or protein drug development and
regulatory submission, including IND/CTA and NDA
Knowledge and experience in and/or direct communication and
interaction with regulatory agencies
A team player/manager experienced in leading, cultivating,
motivating, and developing subordinates and staff.
Open-minded, self-motivated, attention to detail, dedication to
quality and safety of therapeutics.
Ability to work independently and interdependently in a
multi-functional team setting.
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