Director, Preclinical Development (Toxicology and Pathology)

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Job Summary

The Director, Preclinical Development reports to the Vice President, Preclinical Development and is accountable for timely and effective drug safety support for programs in preclinical or clinical development for AVROBIO’s lentiviral-based gene therapies. 

We are looking for an individual to fill this scientific leadership role in Preclinical Development and will be responsible for AVROBIO’s preclinical toxicology and pathology needs. In addition to characterization and oversight of toxicology issues, individuals in this role will also collaborate with the R&D team in establishing hypothesis-driven research aimed at demonstrating efficacy and characterization of toxicity issues related to pharmacology or conditioning. Scientific expertise in biologics or cell and gene therapy drug development, regulatory sciences, and preclinical research is core to this role.

Director, Preclinical Development will supervise the Preclinical Development Team and work cross-functionally to define the preclinical strategy to support lentivirus cell and gene therapy research program, ensuring that AVROBIO considers all appropriate strategic and investigative needs for better lead-candidate selection and characterization of toxicology issues at the time of transition to early development. 

Research and Development
Key Responsibilities

Scientific leader with deep subject-matter expertise who will lead the preclinical pathology and toxicology needs for AVROBIO. This includes actively participating on preclinical and program teams, as well as collaborating with Research, Early Development, and on proof-of-concept initiatives. The candidate may also assist in the identification and review of new business initiatives and in-licensing opportunities.

This individual will be expected to:

  • Design and interpret GLP IND-enabling studies;
  • Review study reports and regulatory documents for technical accuracy and regulatory adequacy.
  • Provide stewardship, toxicology, and pathology support on studies of drug candidates
  • Support Regulatory and Clinical groups for all phases of development, including through preparation of regulatory documents (BB, IND, IB, DSUR, BLA, etc) and responding to regulatory agency interactions concerning toxicology issues.
  • Oversee AVROBIO’s preclinical pathology needs, including sample collection and histopathology evaluation of specimens to characterize preclinical disease models, assess efficacy, or determine target organs and morphologic toxicity profile of our drug product.
  • Conduct pathology peer-reviews of GLP studies performed off-site at CROs.
  • Provide concise written pathology reports that accurately and completely reflect the data collected and the impact on drug development, drug registration and human safety.
  • Develop talent and mentor Toxicologists and Preclinical Development Team members.
  • Develop strategies for addressing toxicology issues and present them to management and governance committees.
  • Collaborate and interface with project leaders across AVROBIO to ensure transition of programs into development.
  • Assist in the regulatory toxicology strategy, guiding development, and project prioritization by responding quickly to data from ongoing studies and providing input to management and development teams.
Minimum Requirements/ Qualifications
  • Must have PhD in Toxicology or related field,or be an DVM with DACVP or DABT board certification.
  • Experience in gene therapy and deep knowledge of pharmaceutical science, drug development of Biologics.
  • Demonstrated ability to be a successful leader and manager, who cares about people and invests in team success.
  • This individual will be a strategic thinker, highly analytical, goal-oriented, with good organization skills and demonstrated ability to adapt and work well with others.
  • Knowledge of regulatory requirements and expectations for first in human approval or registration of pharmaceutics/biologics.
  • Strong verbal and written communication, appropriate for executive or high visible external venues.
  • Strong organizational skills
  • Experience with conducting GLP pathology peer reviews.
  • Experience with team leadership and mentorship.
  • Experience with IHC, imaging, cell transplantation is a plus.

AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.

AVROBIO, Inc is an EEO employer