Director, Toxicology

Our goal is to disrupt today’s chronic care model for treating cardiovascular disease by providing a new therapeutic approach with single-course gene editing treatments.

  • REMOTE
  • San Francisco, CA
  • $160,000 - $230,000
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A bit about us:

JOB DUPLICATED under different client. Please update this section!

Why join us?

JOB DUPLICATED under different client. Please update this section!

Job Details

Responsibilities

Develop and direct the safety strategy throughout the drug development life cycle of current and future gene editing medicines
Lead the toxicology functional area, manage toxicology goals, priorities, resource requirements, budget, and timelines
Provide strategic guidance to project teams and senior management including evaluation of conclusions and potential impact of toxicology results on programs
Develop together with the gene editing, CMC, regulatory and clinical team safety strategies and customized solutions specific for novel editing modalities
Serve as a member of program development teams and collaborate with internal and external research partners including preclinical pharmacology, bioanalysis and translational sciences to advance drug candidates from discovery to clinic
Provide internal expertise to understand the mechanisms of toxicity, propose steps for mitigation and back-up strategies
Design and direct nonclinical safety studies, including the evaluation and interpretation of safety pharmacology, toxicology and toxicokinetic information
Oversee toxicology study monitoring team and either delegate or serve as study monitor and sponsor representative for outsourced studies as needed
Review and provide feedback on study protocols and reports
Communicate toxicology data to stakeholders including nonclinical functional areas, program teams, and executive leadership
Author or facilitate authoring of nonclinical summaries for safety pharmacology, biodistribution and toxicology for submissions to regulatory bodies in US and ROW (e.g., NDAs, INDs, IBs and briefing packages)
Represent Verve in Regulatory Agency interactions for toxicology-related issues
Develop optimal CRO network for toxicology studies, build and maintain effective vendor relationships

Education / Experience

DVM or PhD in a relevant field (Pharmacology, Toxicology) with at least 15 years of post-graduate drug development experience
Board certification in toxicology is highly desirable
Experience in developing toxicology programs to support early and later stage drug development
Experience in authoring of preclinical safety section in regulatory filings such as INDs/CTAs
Knowledge of relevant ICH & FDA guidances and regulations for the strategic planning and conduct of safety studies to support first-in-human (FIH) testing
Extensive experience working with CROs is necessary
Experience with drug development in gene editing, gene or cell therapy is advantageous but not required
Outstanding interpersonal skills and oral and written communication skills
Demonstrated ability to apply critical thinking to solve complex problems to craft customized preclinical strategies for novel therapeutics
Ability to critically evaluate written toxicology documents for overall quality and acceptability of scientific interpretation
Ability to manage a team with remote employees in a hybrid environment
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Job Details
Managed by Jobot Pro
Location
REMOTE
Job Type
Permanent
Compensation
$160,000 - $230,000