Director/Senior Director, Head of Toxicology
We are seeking an exceptional Director/Sr. Director of Toxicology to lead our Safety Pharmacology/Toxicology efforts. The Head of Toxicology will be reporting to VP Nonclinical Development and will providing leadership and scientific expertise to nonclinical safety assessment from early research through clinical development to drive projects toward successful registration. The incumbent will be responsible for all aspects of non-clinical safety including the design, oversight, and interpretation of non-clinical toxicology and investigational safety studies; identification and management of external CROs; and authorization of regulatory documents, including relevant sections of IND and CTA submissions.
- Provide leadership, strategic guidance, and scientific oversight for all nonclinical safety studies conducted to support research and development programs.
- Serve as the nonclinical safety representative on discovery and development project teams. Responsible for interpreting toxicology data and communicating results to program teams and senior management.
- 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.
- Drive the science for investigative and discovery toxicology as needed.
- 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.
- DVM or Ph.D. in Toxicology or relevant field; DABT Board certification preferred.
- 5+ years of experience in Pharmaceutical or Biotechnology industry with a proven track record of conduct of drug safety assessment studies; title will be commensurate with experience.
- Possess an in-depth understanding of regulatory guidance as they pertain to the nonclinical development of therapeutic antibodies and/or small molecules, along with documented experience designing and critically evaluating results of exploratory and GLP-compliant toxicology studies.
- Previous experience in authoring and reviewing nonclinical regulatory documents as well as interactions with regulatory authorities is required.
- 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.
- Must excel at working in a highly collaborative matrix team environment, have good organizational, communication [both oral and written], and interpersonal skills.
ABOUT DISC MEDICINE:
Disc Medicine is a biopharmaceutical company committed to applying our scientific leadership in hematologic diseases to transform the lives of patients. We are committed to bringing hope to patients who suffer from hematologic diseases through innovation. Our team has built a pipeline of first-in-class therapies that each have the potential to address a wide array of hematologic diseases, ranging from rare genetic disorders to widely prevalent anemias associated with chronic disease.
Interested in joining our team? Please contact us at email@example.com
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