Preclinical Toxicologist

Responsibilities

Provides non-clinical pharmacology and toxicology expertise, including but not limited    
•Leadership - provide expert scientific leadership in the areas of non-clinical safety to preclinical discovery project teams, and ensure preclinical packages support clinical development.
•CRO selection & oversight - principle accountability for delivering critical project data through a network of external study providers. In collaboration with project teams, select CROs and participate in study design, troubleshooting, data analysis and interpretation, QC/audit and oversight of study reports.
•Toxicology - design, operationalize and interpret studies to evaluate candidate molecule toxicities, therapeutic index, and overall risk/benefit assessment.
•Regulatory - manage the preparation and/or presentation of nonclinical pharmacology sections of external documents (e.g. Investigator’s Brochure, IND/CTA, PIP, CTD, etc.).
•Flexibility - must be able to contribute to a portfolio of projects spanning early and late preclinical discovery, translational medicine, and clinical development.
•Vision - in collaboration with senior management provide a vision and plan for future growth of pharmacology/DMPK/toxicology functions at SCG
•Communication - play a key role in representing to external parties data, interpretations and nonclinical plans for molecules in our pipeline.

Qualifications

•Must have 6+ years of experience in the pharma/ biotechnology industry
•Master or above in Pharmacology, Pathology or other discipline with appropriate experience/PharmD in Pharmacology or Pharmaceutical Sciences / DVM with appropriate experience
•Strong, demonstrable track record of scientific leadership excellence
•Demonstrated biologics drug discovery experience: track record of advancing multiple novel therapeutic agents from discovery into preclinical and subsequent clinical development as project team leader or member
•Experience in successfully selecting and managing CROs to provide high quality, timely and on-budget studies
•Demonstrated strong written and verbal communication skills - the ability to clearly and persuasively articulate complex concepts and strategies to a diverse audience.
•Experience in oncology is required and additional experience with animal models of infectious diseases strongly is a big plus
•Experience leading a multidisciplinary project team through successful transitions is preferred
•Desire and ability to work in a fast paced, cross-functional, flexible and team-oriented environment