DIRECTOR DRUG SAFETY

Position code: 4312 Position Title: DIRECTOR DRUG SAFETY



Work Location: New Jersey - Nutley Corporate Headquarters



Major Responsibilities:

With the support of the non-clinical toxicologist identifies potential human safety issues from non-clinical safety investigations and published knowledge. Liaise with pre-clinical safety and toxicology to develop implications of animal findings to man. Recommends to the therapeutic area expert appropriate safety monitoring in early human studies. Reviews the clinical drug safety section of the clinical development plan in detail for presentation at decision-making bodies (Research and Development Committee, RDC). Participate in in-licensing safety activities.

Qualifications:

MD, PhD, DVM with a min. of 8 years experience in pharmaceutical industry or 5 years experience working in an academic and/or pharmaceutical industry setting which should include direct experience in pre-clinical research. Experience working with in-licensing evaluations of potential molecular for entry into clinical research is a plus. Drug safety expertise including understanding of clinical safety issues. Broad knowledge of EIM enabling studies and regulatory guidelines for EIM. Knowledge of preclinical concepts in pharmacology and toxicology, speciically of non-clinical pharmacokinetics, drug absorption, distribution, metabolism and excretion and of toxicokinetics (by training or work experience). Understanding of concepts in epidemiology. Proven ability of interpreting results of clinical studies with respect to potential safety relevant to target disease.