Job Summary

The primary focus of the role is bioanalytical method implementation at external CROs and coordination of biological samples analysis for non-GLP and GLP studies in support of clinical development programs across all projects within the Roivant family of companies. The manager will also contribute to relevant regulatory submissions for clinical programs.  Secondary roles within the bioanalytical remit will include CRO site qualifications and study specific audits. The position will include the opportunity to learn and support nonclinical drug metabolism and pharmacokinetic studies. This is an ideal opportunity for a motivated and energetic bioanalytical scientist that wishes to broaden their expertise in nonclinical drug disposition.

Responsibilities

  • Provide operational support to nonclinical and clinical bioanalytical programs for the development of drug candidates by establishing appropriate methods in each species and matrix required to meet development program timelines at qualified CROs
  • Review method development, validation, and stability data to ensure adequate accuracy, precision, reproducibility, and stability, in line with regulatory requirements
  • Ensure on-time delivery of bioanalytical data to project team members by liaising closely between the project team member and the CROs
  • Perform site CRO site qualifications, set up MSA’s and obtain cost estimates for the bioanalytical support of clinical and nonclinical studies
  • Represent the bioanalytical function of the nonclinical department on project teams to critique and interpret existing data and develop and execute project plans to support clinical development
  • Support the product development teams by providing operational and scientific oversight for studies in other DMPK disciplines such as drug metabolism, PK, and in vitro transporter studies; this may be a growth opportunity for scientists with strong expertise in bioanalysis that wish to broaden their experience in nonclinical drug development
  • Author and review regulatory submissions (INDs, CTAs, IBs, NDAs, etc.)
  • Participate in performing reviews of due diligence data packages to identify issues/risks/gaps to development
  • Effectively communicate data to project teams, senior management, and collaborators as necessary
  • Present data in the form of poster and/or oral presentations at relevant scientific meetings; draft manuscripts for peer-reviewed literature based on study results

Qualifications

  • BS/MS with at least 5 years of relevant pharmaceutical industry (or related industry) experience
  • Track record in developing LC-MSMS based bioanalytical methods; additional expertise in biological methods (e.g. ELISA) would be a plus
  • Experience providing bioanalytical expertise and support for multi-disciplinary drug development teams
  • Experience in providing scientific oversight to outsourced bioanalytical assays
  • Experience in managing or performing regulated (GLP) bioanalysis
  • Familiarity with DMPK disciplines such as TK/PK, in vivo metabolism, transporters, or metabolite identification
  • Ability to analyze and interpret study data with minimal supervision
  • Experience working in a fast-paced company or in a multi-project support role with a proven ability to manage multiple projects/tasks at one time is essential
  • Excellent written and oral communication skills

Personal Attributes

  • Self-starting motivation and entrepreneurial spirit
  • Ability to thrive in a quickly changing, fast-paced environment
  • Desire to work in multiple therapeutic areas
  • Unrelenting dedication to delivering quality results
  • Moral integrity in word and action
  • Willingness to roll up your sleeves to get the job done
  • Ability to work with CRO personnel and gain their trust and respect
  • Willingness to travel up to 15% of the time
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