Associate Director, Toxicology and Biodistribution Full Time

Voyager is seeking an Associate Director level individual to help advance our drug development candidates for investigating life-saving gene therapies for severe neurological disease. This newly created role requires a firm understanding of biologics/vaccine (large biomolecules) safety assessment, biodistribution and molecular biology assessments in multiple species such as rodents, lagomorphs, ungulates, canines and non- human primates. The successful candidate must have the ability to multitask, to function effectively in a fast-paced environment, be capable of conducting work independently but also capable of pulling in subject matter experts when necessary to lead the conversation. The individual must have an overall knowledge of toxicology and molecular biology, be able to integrate all animal findings and understand the relevance of the findings to the clinical situation and communicate succinctly when issues arise.

Responsibilities

In conjunction with program teams, develop toxicology strategies and provide expert support to development projects.
Collaborate on the design of non-GLP investigative and pharmacology studies to support developmental compounds, as needed.
Directly interface with contract research organizations (CROs) to request quotes and derive cost estimates and work closely with Finance to develop program budgets. Additional responsibilities include working closely with the contracts group to develop confidentiality agreements, statements of work and track all expenses and invoices.
Plan, coordinate, execute, and oversee the conduct of external GLP biodistribution and toxicology studies to support development programs.
Be responsible for all sub-vendor activities that use molecular biology techniques to address the pharmacology endpoints in both DMPK
Review and summarize t and integrate complex data sets across multiple disciplines
Manage the preparation and presentation of nonclinical safety data for project teams, management presentations, and internal /external partners and scientific groups.
Provide strategic advice to project teams and senior management including evaluation of conclusions and potential impact of results on program and clinical/regulatory strategy.
Finalize toxicology reports and all sub-vendor reports, manage the tabular presentation of data in accordance with CTD format and have a familiarity with SEND requirements.
Support the preparation of national and international regulatory submissions and interactions with governments. And be capable of effective communications with regulatory bodies in the process of product defense.
Manage and prepare toxicological risk assessments to support drug development and manufacturing.
Interact cross functionally with Research, Regulatory, Clinical and Manufacturing.
Work closely with Clinical to support and defend with data the clinical trial design plans.
Knowledge of archiving requirements a must.

Qualifications

Doctoral degree (Board certification or eligibility) and training in a field related to industrial Pharmacology /Toxicology in a scientific discipline that encompasses the basic biologic sciences, including virology, molecular biology, histology and pathology and DMPK
Minimum of 10 years of pharmaceutical or biotechnology industry experience as a nonclinical toxicologist.
Proficient in both verbal and written communications.
Required ability to plan travel and oversee conduct of in life studies and necropsy of animals in a study.
Knowledge of global regulatory guidance’s (ICH /FDA) and Good Laboratory Practices.
Must be able to critically evaluate written and published toxicology documents for overall quality and acceptability of scientific interpretations.
Experience in developing toxicology program to support early and later stage drug development and in preparing regulatory filings such as INDs/CTAs, BLA activities, IB, DSUR.
Must be comfortable with periods of heavy travel

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