Agenus

  • Director/Sr Director of Toxicology and Safety Pharmacology

    Job Locations US-MA-Lexington
    Job ID
    2018-1442
    Category
    Research
  • Overview

    Agenus is seeking an innovative Senior Toxicologist to help advance a variety of drug development candidates which will have utility the exciting immunobiology therapeutic arena

    This role requires a firm understanding of biologics/vaccine (large biomolecules) safety assessment in multiple species such as rodents, and non- human primates. The ideal candidate will be one who cherishes the ability to create novel and impactful approaches to an area which has been truly at the forefront of cancer research

    As the Senior Toxicologist, you will lead all aspects of toxicology work for select nonclinical programs around selected vaccines as well as immune-oncologic candidates. The candidate will be involved in multiple aspects from research through development and IND enabling studies. You will design, execute, and interpret nonclinical safety studies conducted in appropriate toxicological species. You will be involved in regulatory submissions and interactions with various health authorities as well as the in- house Clinical Team.

    The successful candidate must have the ability to multitask, and function effectively in a fast-paced environment. One must be capable of conducting work independently, but also capable of engaging outside experts when necessary to lead the conversation. Have a positive energy and be successful in leading projects to conclusion.

    The ideal candidate will possess an overall knowledge of biology and integrate all animal findings to understand the relevance of the findings to the human situation and communicate succinctly when issues arise.

    Responsibilities

    Responsibilities

    • In conjunction with program teams, develop toxicology strategies and provide expert support to research and 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 Res Ops 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 toxicology studies to support development programs.
    • Review, summarize and integrate complex data sets across multiple disciplines
    • Manage the preparation and presentation of nonclinical safety data for project teams, portfolio 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

    Qualifications

    • Doctoral degree and training in a field related to industrial pharmacology /Toxicology in a scientific discipline that encompasses the basic biologic sciences, including molecular biology, histology and pathology and DMPK
    • Minimum of 4 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 and necropsy of animals in a study.
    • Knowledge of global regulatory guidance (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.

    What can Agenus offer:

    • This is a company that offers a dynamic learning culture in a global setting.
    • Company has been a pioneer in immunobiology and has demonstrated the ability to progress agents toward the clinical rapidly.
    • The group is supportive of growth and development of leadership opportunities.

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