About Dermavant:


Dermavant Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies for inflammatory skin diseases and medical dermatologic conditions. We are passionate and dedicated to realizing the full potential of biomedical research and to developing and commercializing novel first-in-class or best-in-class therapies that improve patients’ lives. The patient is at the heart of everything we do.


Position:


The Director, Clinical Operations will be accountable for the implementation, management and reporting of assigned clinical trials. In this role, she/he will lead a team that executes the clinical studies in conformance with Good Clinical Practices (GCP) and in accordance with the International Conference of Harmonization (ICH) Guidelines.As a key member of the clinical study team you will be accountable for all aspects of assigned study execution including where applicable, CRO selection, study plan design, execution, study start-up, CRO and vendor management and performance, study budget and timelines. Develops all study plans in collaboration with the CRO. Manages all aspects of clinical operational plan. Responsible for managing full scope of study, protocol.


Responsibilities:


  • Lead Contracting / Outsourcing Process:
  • Identification, evaluation, selection, training, and ongoing relationship development of vendors (CROs, labs, medical writers, statisticians, bioanalysis, etc),
  • Generate, manage, and track proposals and contracts (RFPs, MSA, SOW’s, etc)
  • Information maintenance to enable internal benchmarking for future clinical studies
  • Training CRO, monitors, and clinical sites (via Investigator meetings or Site Initiation Visits)
  • Oversee Study Set Up Process: Develop Clinical study proposal/protocol, establish Investigator meetings, create site source documentation tools, electronic database set up, IRB process, forms and procedures manual, site preparation, study supplies, lab services, coordinate drug supple, etc.
  • Lead Study Conduct, Execution, and Close Out:
  • Identify recruitment goals
  • Review/approve monitoring visit reports
  • Manage interim data analyses
  • Study close-out (archive appropriate documentation, study records, study analysis archive, all remaining sponsor records as appropriate).
  • Budget management (initial budget development + life of study/program budget management)
  • Interface with CMC contact for management of study drug/supplies
  • Manage outsourcing of CSR, CTR summary, etc. based on sourcing strategy for study.
  • Contribute to design of phase II and III clinical development programs, clinical studies; drafting of high quality, regulatory compliant study protocols and other required clinical documents
  • Contribute to Clinical development plan (literature searches, competitor landscape, recruitment & treatment projections, etc)
  • Liaise with CRO on Investigational Review Boards (IRBs) and Ethics Committees (ECs) requirements and questions.



Qualifications:

  • Bachelor’s degree in Life Sciences, Pharmacy or Life Sciences. Advanced degree preferred.
  • 5+ years of experience working in industry and or with a CRO is required-managing clinical studies. The director must be able to work collaboratively with others both internally and externally.
  • Prior experience in clinical research development activities combined with direct clinical operations study management experience
  • Dermatology experience preferred or 8-10 years of multi-therapeutic clinical operations experience
  • Good working knowledge of GCP and ICH guidelines
  • This position requires approximately 20% travel.


What we look for in our people:

  • Highly motivated self-starter with an entrepreneurial spirit and commitment to personal and career development.
  • Desire to work in a quickly changing and fast-paced growing business.
  • Unrelenting dedication to delivering results and a desire to shape the strategic goals of the business. Willing to roll up your sleeves to get the job done.
  • Ability to overcome ambiguity and challenge the status quo
  • Manage multiple programs with competing and aggressive time lines, prioritize activities, and work independently.
  • Excellent written and oral communication skills; experienced presenter of key messages to broad audiences including Senior Stakeholders

This position has been filled.