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Director, Toxicology at Decibel Therapeutics
Boston, MA, US

Position Overview & Responsibilities

Decibel is seeking a Director of Toxicology to progress a broad portfolio of drugs across multiple modalities (small molecule, mAb, gene therapy etc.) in a fast paced and dynamic biotech environment.

  • Direct participation in discovery programs as the head of toxicology evaluation, including oversight of strategy, toxicology study design, data interpretation, document authoring, IND writing (2.6.2 and 2.6.6.) and regulatory interactions
  • Work closely with development teams to drive toxicology activities that support clinical advancement (chronic toxicity, carcinogenicity and DART assessments) leading to regulatory interactions for registration
  • Ensure appropriate project management and oversight for multiple CROs to enable appropriate/timely initiation, progression and completion of nonclinical studies
  • Develop overall toxicology evaluation strategy for Decibel portfolio, including evaluation of in-licensing opportunities
  • Serve as the internal expert for the design of project-specific strategies to predict, assess and mitigate target- and treatment-related safety risks; provide expert opinion on non-clinical safety and risk assessment to senior management
  • Develop and oversee toxicology budgets
  • Generate, analyze and present data, both orally and as written reports; deliver presentations internally or externally as needed

Requirements

  • PhD in toxicology or related field or DVM with minimum of 10-12 years of relevant industry experience
  • Expertise in technical, scientific, and regulatory aspects of toxicology evaluation
  • Proven ability to design, manage and interpret outsourced toxicology studies
  • Demonstrated ability to tackle complex scientific problems to enable first in man dosing or progression of programs into late-stage development
  • Previous experience having progressed molecules into first in man (IND) is a must, through to registration is a plus
  • Comprehensive understanding of the interplay between toxicology, pharmacology, biomarkers, DMPK and formulations
  • Experience with investigative toxicology including proven ability to research and develop strategy around novel findings
  • Extensive experience interfacing with, and providing scientific guidance to, CRO partners and proven ability to work efficiently in a hybrid model
  • Experience interacting with worldwide regulatory agencies and authoring regulatory filings
  • Proven success in supporting cross-functional project teams and ability to collaborate in a cross-functional matrixed organization
  • Strong oral communication skills and demonstrated proficiency at technical writing are essential
  • Ability to integrate data across disciplines and communicate salient data to executive leadership and/or a broad audience

Additional Desirable Experience

  • DABT and/or DACVP is preferred
  • Previous experience with local delivery modalities is a plus
  • Experience in successful development of gene therapy toxicology programs and FDA OTAT interactions is highly desirable

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