Toxicology Expert

3 days 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 neurodegenerative diseases. Our team of neurodegenerative biologists from Harvard Medical School and Harvard University is dedicated to discovering and developing effective precision medicines.

Job Summary

We are seeking a highly motivated Toxicology Expert to support our toxicology strategy for successful development of our lead molecules across all stages of development. This position will provide scientific expertise associated with Toxicology and Safety Pharmacology needs on Discovery and Development Project Teams.

Key Responsibilities
  • Serve as Preclinical Safety project team representative on multi-disciplinary Discovery and Development teams responsible for the progression of both small molecule compounds and ASOs for regulatory submissions.
  • Interact with multiple functions (Pharmacology, Regulatory Affairs, Clinical, Project Leaders & Managers, etc.) on a daily basis.
  • Participate in issue-resolution teams, where you will be required to 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 (staff meeting, scientific forums, etc.), 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.

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