Director/Senior Director, Head of Toxicology

Director/Senior Director, Head of Toxicology

We are seeking an exceptional candidate who shares our passion and drive to make a difference in the lives of cancer patients to lead our Safety Pharmacology/Toxicology efforts. The Head of Toxicology will be part of the Preclinical Development function providing leadership and scientific expertise to nonclinical safety assessment from early research through clinical development to drive projects toward successful registration. The successful candidate will thrive in an innovate, fast-paced, and collaborative environment.

Position Responsibilities

  • Provide leadership, strategic guidance and scientific oversight for all nonclinical safety studies conducted to support research and development programs
  • Design, monitor, analyze and report nonclinical safety pharmacology and toxicology studies conducted in collaboration with contract research organizations
  • Address and resolve toxicology issues arising in drug development programs, and adequately assess the relevance of findings to human safety
  • Design and execute investigative toxicology studies to understand the mechanisms of toxicity observed to drive mitigation and/or back-up strategies
  • Serve as the nonclinical safety representative on discovery and development project teams
  • Provide strategic guidance to senior management including evaluation of conclusions and potential impact of toxicology results on program and clinical/regulatory strategy.
  • Build collaborative networks with external experts to evaluate emerging safety issues
  • Responsible for lead authorship of pertinent sections of regulatory submission documents including INDs, NDAs, annual reports, briefing documents, and investigator’s brochures
  • Represent nonclinical safety at regulatory meetings and responses to queries from health authorities
  • Manage toxicology function goals, priorities, budget, and timelines
  • Build and lead a strong toxicology function

Position Requirements

  • DVM or Ph.D. in Toxicology or relevant field; DABT Board certification preferred
  • 10+ years of experience in the pharma industry with a proven track record of conduct of drug safety assessment studies; title will be commensurate with experience
  • Demonstrated subject matter expert in regulatory toxicology
  • Track record of toxicology leadership on oncology development programs
  • Experience progressing drug candidates through preclinical development with successful achievement of drug candidate INDs and/or BLAs/NDAs/MAAs
  • Experience managing studies at contract research organizations
  • Previous managerial experience is preferred
  • Ability to work in a fast-paced, roll-up-your sleeves environment is essential
  • Superior communication skills, including the ability to influence cross-functionally and articulate complex issues clearly to drive understanding and decision-making
APPLY NOW

Director/Senior Director, Head of Toxicology

APPLY NOW