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Toxicology Expert

2 months ago

Cambridge, Massachusetts, United States QurAlis Full time
About QurAlis

We are a clinical-stage biotechnology company advancing a pipeline with therapeutic candidates that target specific components of ALS and FTD pathology and defined patient populations based on both disease-causing genetic mutation(s) and clinical biomarkers.

Job Summary

We are seeking a highly motivated Toxicologist to support our toxicology strategy for successful development of our lead molecules across all stages of development.

Key Responsibilities
  • Design and coordinate a multi-disciplinary effort to support preclinical safety projects through the development of the nonclinical safety strategy and program.
  • Interact with multiple functions on a daily basis, including Pharmacology, Regulatory Affairs, Clinical, Project Leaders & Managers, etc.
  • Participate in issue-resolution teams and contribute to hypotheses generation and drive the science for toxicology issue resolution in drug discovery and development.
  • Participate in Preclinical safety-US and global Preclinical safety department activities, and special projects.
  • Provide scientific input on design and analysis of research activities.
  • Serve as internal expert for scientific issues related to nonclinical safety issues.
  • Ensure high scientific standards and adhering to requested timelines in all aspects of the position.
Requirements
  • BS/MS degree and DABT with 10 yrs. of relevant experience.
  • PhD degree in toxicology, pharmacology or related disciplines with a minimum of 5 yrs. of experience, DABT preferred.
  • Minimum of 3 years of relevant industry experience.
  • Demonstrated drug development experience in non-clinical toxicology, including program design, study protocol development and study execution.
  • Experienced with non-clinical development programs for small molecules and antisense oligonucleotides or siRNA.
  • In-depth understanding of the drug development process and intimate understanding of non-clinical development.
  • Knowledgeable about GLP policies and/or regulatory nonclinical testing requirements for pharmaceutical development of biotherapeutics and small molecules.
  • In-depth familiarity with ICH, FDA and other regulatory guidance and regulations relevant to non-clinical research.
  • Excellent written and oral communication, interpersonal, and organizational skills.
  • Initiative in producing high quality work product in a small company environment.
  • Roll-up-the-sleeves attitude.
  • Competence with standard office computer software tools.
  • Ability to align activities with company objectives.
  • Meticulous nature with high attention to detail.
  • Able to work independently and work well in a team environment in a fast-paced environment.
  • Strong organizational skills.
  • Excellent written and oral communication with key stakeholders and work collaboratively.
Preferred Qualifications
  • Knowledge in biochemistry, toxicology, pharmacology, neuroscience, physiology, and statistics.
  • DABT certification is preferred, but not required.
  • Experience as a GLP study manager is preferred.
  • Proven ability to work in an international environment and with cross-functional teams, with good interpersonal skills/assertiveness/team spirit/coaching skills.
  • Early clinical phase experience with neuromuscular and/or neurodegenerative indications.