Company: Roivant Sciences, Inc.

Role: Manager, DMPK – Drug Disposition and Modeling

Location: Durham, North Carolina

Start Date: ASAP

Reports to: Director, DMPK

Compensation: Competitive and commensurate with experience


Roivant’s employees are its most important assets. We are seeking exceptional talent for our Nonclinical Drug Disposition and Modeling (DDM) group, which provides expertise and support to programs across the Roivant family and subsidiaries.

The primary focus of the role is the implementation and management of in vitro and in vivo drug metabolism and pharmacokinetic (DMPK) studies at external CROs 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 DMPK remit will include CRO site qualifications and study specific audits. The position will include the opportunity to learn and support nonclinical studies including bioanalytical, pharmacology and safety assessment. This is an ideal opportunity for a motivated and energetic scientist that wishes to broaden their expertise in nonclinical drug disposition.


Responsibilities include:

  • Provide operational support to nonclinical DMPK programs for the development of drug candidates by establishing appropriate study designs required to meet development program timelines at qualified CROs
  • Review and revise study designs, methods, results and conclusions of in vitro and in vivo ADME and in vitro drug-drug interaction studies in context of the clinical development program and ensure alignment with current regulatory requirements
  • Ensure on-time delivery of key DMPK 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 of nonclinical studies
  • Conduct non-compartmental PK/TK analysis (e.g. WinNonlin) and draft study reports to support DMPK, pharmacology and safety assessment projects
  • Represent the DDM 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 nonclinical disciplines; this may be a growth opportunity for scientists with strong expertise in a key aspect of DMPK 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
  • Effectively communicate data to project teams, senior management, and collaborators
  • 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


We are looking for a top-quality individual with the following characteristics:

  • Self-starting motivation and entrepreneurial spirit
  • Moral integrity in word and action
  • Ability to thrive in a quickly changing, fast-paced environment
  • Desire to work in multiple therapeutic areas
  • Unrelenting dedication to delivering quality results
  • 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


Requirements for consideration include:

  • PhD preferred, or BS/MS with equivalent experience; at least 5 years of relevant pharmaceutical industry (or related industry) experience is desired
  • Track record of conducting in vitro drug metabolism and drug-drug interaction studies; additional expertise in in vivo ADME/PK or bioanalytical studies would be a plus
  • Experience in providing scientific oversight to outsourced DMPK assays and managing operational aspects of in vitro and/or in vivo DMPK studies
  • Broad knowledge of DMPK and its related disciplines (e.g. Pharmacology, Toxicology) and nonclinical drug development (e.g. Manufacturing, Clinical, Regulatory)
  • 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


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