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Scientist II, Toxicology

Position Summary:                     

Achaogen is a clinical-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of innovative antibacterials to treat multi-drug resistant, Gram-negative infections. In light of recent positive Phase 3 data for our NDA-candidate, plazomicin, and a growing pipeline that includes two small molecules in early development and multiple large and small molecule discovery programs, we are looking for an accomplished toxicology to join our growing team.

We seek a highly motivated and driven toxicologist with experiences in preclinical safety evaluation of drug candidates (small and/or large molecules). This position will provide an exciting opportunity to support the Toxicology team as they advance drug development programs through IND/NDA, and partner with the research group as they look to translate their work into the clinic. If you are passionate about science, looking to grow in your career, and are committed to performing rigorous experiments that inform drug development, then this is the place for you!

Essential Functions:

  • Responsible for providing non-clinical toxicology and safety pharmacology expertise to support drug discovery, drug development, regulatory, and post-marketing commitments for both small and large molecule programs.
  • Responsible for non-clinical study design, study result interpretation, and report finalization.
  • Collaborate with Research in the screening and selection of lead candidates using existing assays and through the development and validation of novel methods.
  • Serve on project teams as the accountable toxicology representative; design and implement the safety testing strategy to support drug development projects.
  • Assess mechanism(s) of toxicity to determine clinical relevance and ways to minimize clinical impact; provide perspective on safety concerns prior to and during clinical trials.
  • Prepare non-clinical regulatory documents (study summaries, CTD tables, IB, IND and NDA/MAA sections, etc.), respond to questions from Regulatory Authorities, and interact with Regulatory Authorities.
  • Work cross-functionally across the organization, including Regulatory, Research, Clinical Research, Quality Assurance, and Manufacturing groups, etc.
  • Contribute to the preparation of non-dilutive funding proposals.
  • Collaborate with consultants, key contacts and experts in the field.
  • Partner with the study management group to ensure operational and scientific rigor for outsourced studies  at Contract Research Organizations (CROs).
  • Up to 10% travel within North America may be required.

Essential Experience:

  • Successful candidates will have a MS with 8-10 years or PhD with 3-5 years of experience as a toxicologist within the biopharmaceutical industry.
  • Candidates must be familiar with the worldwide nonclinical testing guidelines to support clinical development and regulatory filings.
  • Experience in developing IND testing programs and in preparing IND filings.

Preferred Experience:

  • Experience with antibody drug development, or expertise in safety pharmacology.
  • DABT accreditation preferred.

Preferred Additional Skills:

  • Motivated and passionate about making a difference for unmet medical needs.
  • Strong oral and written communication skills and business partnering ability.
  • Strong interpersonal skills and ability to work with others in a positive, collaborative manner, inspiring trust and confidence with colleagues.
  • Committed to values of integrity, accountability, transparency, scientific rigor and drive.
  • Current US work authorization required.
  • Ability to travel domestically.
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