Company: Roivant Sciences, Inc.

Role:Internship: PhD Candidate/ Postdoctoral Fellow / PharmD

Location:Durham, NC

Start Date:Multiple, rolling opportunities (ASAP through February 2018)

Reports to:Directors of Pharmacology, Toxicology, DMPK, Clinical Pharmacology, Regulatory (candidate/position dependent)

The Company

Roivant Sciences is a development-stage biopharmaceutical company focused on realizing the full value of promising drug candidates and systematically reducing the time, cost and risk of delivering new drugs to market. Roivant aims to develop under-resourced or deprioritized drug candidates across therapeutic areas of significant medical need. Our innovative business model was recently featured in a Forbes cover story.

Roivant is rapidly expanding its pipeline and the number of subsidiaries (or “Business Units”) around therapeutic areas of interest. Examples includeAxovant(dementia), Myovant (women’s health), Enzyvant (rare diseases), Dermavant (dermatology); and we plan to continue increasing the number of business units across multiple therapeutic areas. We currently have 14 clinical programs ranging from Phase I through Phase III (see for more details).

The Role

We are seeking exceptional talent for our Nonclinical, Clinical Pharmacology,and Regulatory groups, which will provide exposure to multiple therapeutic areas across the subsidiary companies. This rotation will offer an overview and provide real world experience of the drug development process.

The PhD candidate,postdoctoral fellowor PharmDselected for this rotation will work with a multi-disciplinary team of scientists with a track record of successful FDA approvals.Responsibilities include (but are not limited to) attending project team meetings, meeting with contract research organizations (CROs), learning to review regulated protocols, gaining an understanding of Good Practices (GLPs, GCPs, GMPs), designing applied pharmacology or toxicology studies, design and conduct of clinical pharmacology studies, reviewing and interpreting nonclinical and clinical data, revising CRO study protocols/reports to generate quality reports for regulatory submissions, regulatory document reviews, regulatory strategy discussions, and direct contributions to regulatory submission documents.

The PhD candidate,postdoctoral fellow or PharmDwill be given specific research projects to provide resource to various Roivant line functions. Potential projects include 1) researching target biology 2) determining appropriate pharmacology models that demonstrate drug efficacy and clinical translation for specific therapeutic targets 3) comparing pharmacology/toxicology packages of marketed products to provide development recommendations for newly acquired or putative Roivant compounds, 4) authoring abstracts and poster presentations of preclinical study data, 5) characterizing the absorption, distribution, metabolism or elimination (ADME) properties of clinical-stage drug development candidates,6) compiling, analyzing, and benchmarking asset/competitor clinical pharmacology information, 7) conducting Regulatory intelligence research on recent legislation or Guidance for US and International regulatory affairs, 8) transfer of IND files to support product integration into the Roivant Sciences portfolio, and 9) authoring regulatory submission documents targeted toward advancing the product development pipeline.

We are looking for top quality individuals with the following characteristics:

  • Deeply motivated self-starter with an entrepreneurial spirit
  • Ability to work independently and in a team environment
  • Desire to work in a quickly changing, fast-paced environment
  • Unrelenting dedication to delivering quality results
  • Being a role model of integrity by visibly and consistently speaking and acting with superior moral values
  • Willing to roll up your sleeves to get the job done

Requirements for consideration include:

  • Senior PhD candidate,postdoctoral fellows,PharmD fellows
  • Ability to manage multiple projects/tasks at one time
  • Excellent written and oral communication skills
  • Analytical andcreative problem solver
  • Able to work full-time (40hr/week for 4 weeks, 160hr total)

For more information, please contact Brante Sampey: