Toxicology Program Manager- Pharma

Our client is focused on the discovery and development of novel and selective small molecule drugs targeting ion channels and large classes of receptors. With a drive for developing ground breaking therapeutics and diagnostic technology, our clients strong collaborations with well established leaders in the Pharmaceutical Industry has pushed them to the forefront of the Pharmaceutical industry.

Our current opportunity is seeking a driven and established scientist to take a lead role in managing late stage Toxicology Programs.

This role would involve designing and overseeing the nonclinical safety testing programs for assigned clinical candidates in development.

Specific responsibilities will include:
Nonclinical study design, contract research laboratory (CRO) selection/study
director interactions/monitoring, study result interpretation, report finalization, and preparation of integrated nonclinical summaries for IND and NDA submissions. This person will interact with all levels of the organization, including Regulatory, Operations, Discovery Research, Clinical Research, Quality Assurance, and Manufacturing groups.

Education & Experience:
Our ideal candidate should have a Ph.D. with 5-10 years of experience as a toxicologist
within the biopharmaceutical industry. Post-doc experience preferred in
toxicology or pharmaceutical development. Must be familiar with
the worldwide nonclinical testing guidelines to support clinical development
and registrational filings. Experience in developing IND testing programs
and in preparing IND and NDA/MAA filings critical. Knowledge of
pharmacokinetics or toxicology specialization is desirable.




job Requirements


Please refer to the job description above.