QurAlis
Toxicologist
QurAlis, Cambridge, Massachusetts, us, 02140
ABOUT THE COMPANYAt QurAlis, we are neuro pioneers on a quest to cure. We work with a relentless pursuit of knowledge, a precise attention to craft, and an optimistic mindset to discover and develop effective precision medicines that will alter the trajectory of amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), and other neurodegenerative diseases. Founded by an internationally recognized team of neurodegenerative biologists from Harvard Medical School and Harvard University, QurAlis is 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.Summary of PositionQurAlis is seeking a highly motivated Toxicologist to
support their toxicology strategy for successful development of the company’s lead molecules across all stages of
development.
Reporting to the Senior Director of Toxicology, this position will provide a wide range of scientific expertise associated with Toxicology and Safety Pharmacology needs on Discovery and Development Project Teams of QurAlis. Working closely with different teams from Discovery to Clinic within QurAlis, this position would provide toxicology scientific expertise across the drug discovery and development value chain on small molecules and ASOs. This position is based in Cambridge MA.Primary Job 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. These activities include designing and coordinating a multi-disciplinary effort to support such projects through the development of the nonclinical safety strategy and program which includes, but is not limited to attending various project team meetings; the design and interpretation of toxicity studies; the preparation and/or review of written safety pharmacology and toxicology reports; and the authoring of the nonclinical document sections for regulatory submissions (including CIBs INDs, MAAs, CTAs, CTDs and BLAs)Interact with multiple functions (Pharmacology, Regulatory Affairs, Clinical, Project Leaders & Managers, etc.) on a daily basisParticipate in issue-resolution teams, where she/he 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 projectsParticipate in special projects or inter-industry working groups, as needed.Provide scientific input on design and analysis of research activitiesServe as internal expert for scientific issues related to nonclinical safety issuesEnsure high scientific standards and adhering to requested timelines in all aspects of the positionPrimary Job 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 experienceDemonstrated drug development experience in non-clinical toxicology, including program design, study protocol development and study executionExperienced 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 moleculesIn 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 detailAble to work independently and work well in a team environment in a fast-paced environmentStrong organizational skillsExcellent written and oral communication with key stakeholders and work collaborativelyPreferred 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.
#J-18808-Ljbffr
support their toxicology strategy for successful development of the company’s lead molecules across all stages of
development.
Reporting to the Senior Director of Toxicology, this position will provide a wide range of scientific expertise associated with Toxicology and Safety Pharmacology needs on Discovery and Development Project Teams of QurAlis. Working closely with different teams from Discovery to Clinic within QurAlis, this position would provide toxicology scientific expertise across the drug discovery and development value chain on small molecules and ASOs. This position is based in Cambridge MA.Primary Job 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. These activities include designing and coordinating a multi-disciplinary effort to support such projects through the development of the nonclinical safety strategy and program which includes, but is not limited to attending various project team meetings; the design and interpretation of toxicity studies; the preparation and/or review of written safety pharmacology and toxicology reports; and the authoring of the nonclinical document sections for regulatory submissions (including CIBs INDs, MAAs, CTAs, CTDs and BLAs)Interact with multiple functions (Pharmacology, Regulatory Affairs, Clinical, Project Leaders & Managers, etc.) on a daily basisParticipate in issue-resolution teams, where she/he 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 projectsParticipate in special projects or inter-industry working groups, as needed.Provide scientific input on design and analysis of research activitiesServe as internal expert for scientific issues related to nonclinical safety issuesEnsure high scientific standards and adhering to requested timelines in all aspects of the positionPrimary Job 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 experienceDemonstrated drug development experience in non-clinical toxicology, including program design, study protocol development and study executionExperienced 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 moleculesIn 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 detailAble to work independently and work well in a team environment in a fast-paced environmentStrong organizational skillsExcellent written and oral communication with key stakeholders and work collaborativelyPreferred 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.
#J-18808-Ljbffr