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Senior Scientist, Toxicology

Employer
Xenon Pharmaceuticals Inc.
Location
Boston, MA
Start date
Oct 22, 2021

View more

Discipline
Science/R&D, Biotechnology, Toxicology
Required Education
Masters Degree/MBA
Position Type
Contract
Hotbed
Genetown

Xenon Pharmaceuticals (NASDAQ:XENE) – a biopharmaceutical company with operations in Vancouver, BC, Canada and Boston, MA, USA – is committed to delivering innovative medicines to provide a brighter future for patients suffering from neurological disorders. 

At Xenon, we are advancing an exciting pipeline of neurology-focused therapies, with a particular emphasis on novel treatments for both adult and pediatric patients with epilepsy. XEN496 is currently being evaluated in the Phase 3 “EPIK” clinical trial in young patients with KCNQ2-DEE, a rare and severe form of childhood epilepsy. Late-stage development plans are also underway for our XEN1101 program, building upon the compelling data from the Phase 2b “X-TOLE” study in adult patients with focal epilepsy. We are also proud of the leading-edge science coming out of our discovery labs, with many early-stage research programs underway. In addition to Xenon’s proprietary programs, we have ongoing collaborations with our valued pharmaceutical partners. With a healthy balance sheet to support our growth plans, we continue to build a fully-integrated, premier neuroscience company with strong discovery, development, and commercial operations.

Our employees are smart, passionate, dedicated, and driven by their incredibly important work to discover, develop, and deliver new medicines for patients in need. Building and maintaining a respectful, collaborative, inclusive, and productive culture is a priority for us.  We are looking for great people who thrive in a fast-paced, dynamic work environment to join our team during this transformative time for Xenon.

Xenon is looking to hire a Senior Scientist, Toxicology with a proven track record in non-clinical safety assessment of small molecules and their metabolites in support of the Company’s IND/CTA and NDA submissions.

This position reports to the Senior Director, Translational Drug Development and will be located in either the Vancouver, BC, Canada or Boston, MA, USA location; we may consider other locations for an exceptional candidate. Relocation and immigration support will be provided, if required.


RESPONSIBILITIES:

  • Plan, design, conduct, interpret, and report of in vitro/in vivo safety pharmacology and toxicology studies
  • Manage the timeline and conduct of internal and external toxicology studies to ensure timely generation of data and report finalization to support clinical trials
  • Develop comprehensive safety target reviews with risk mitigation plan for early drug discovery project teams based on literature, in silico assessment, and other predictive tools
  • Establish pharmacology and/or toxicology profile of disproportionate metabolites and potential genotoxic impurities and qualification of such impurities
  • Author relevant sections of regulatory modules and regulatory documents (IB’s, briefing packages, IND’s, CTAs, NDA’s, etc.)
  • Maintain knowledge of relevant scientific and regulatory practices, guidance and trends, and ensure that toxicology aspects of development programs are contemporary
  • Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics
  • Some travel may be required
  • Other duties as assigned

QUALIFICATIONS:

  • MSc or PhD in Toxicology, Pharmacology or a related scientific discipline with minimum 10 years of industrial experience
  • Extensive understanding of toxicology principles and hands-on experience with planning and conducting non-clinical safety studies for development of small molecules
  • Expert in critical review of safety pharmacology and toxicology study protocols/reports with good knowledge of bioanalytical method validation, pharmacokinetic/toxicokinetic and data presentation
  • Thorough knowledge and understanding of the nonclinical drug development process and regulatory filings
  • Good communication and interpersonal skills for successfully working in multidisciplinary teams
  • Ability to work independently and in multidisciplinary teams with excellent written and verbal communication skills

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