OneTrust

Director, Epidemiology – Neuroscience

OneTrust

full-time

Posted on:

Location Type: Remote

Location: Remote • Pennsylvania • 🇺🇸 United States

Visit company website
✨ AI Apply
Apply

Salary

💰 $164,000 - $282,900 per year

Job Level

Lead

Tech Stack

SQL

About the role

  • Lead epidemiology support for lumateperone (CAPLYTA) and our portfolio of depression-related compounds in development.
  • Lead the implementation of the REWARD initiative, an ambitious collaborative effort using observational database analyses to enable exploration and identification of differentiated benefits of medical products to support R&D's clinical development strategy.
  • Identify research study needs, draft proposals and protocols, and contribute to real-world evidence (RWE) strategy and study conduct across the neuroscience therapeutic area portfolio.
  • Lead RWE generation to support regulatory activities and inform decisions made by Global Medical Safety (GMS).
  • Work closely in collaboration with colleagues in the Epidemiology group when defining research questions, developing epidemiological protocols, conducting analyses, and interpreting and communicating evidence to internal and external stakeholders.
  • Participate in various multi-disciplinary matrix teams to address issues raised by product teams/regulatory agencies where real-world data (RWD)/RWE can inform decisions.
  • Provide epidemiological and/or statistical consulting and support to compound/product teams, and disseminate technical information through reports, presentations, and publications in peer-reviewed literature as agreed by the team.
  • Work within and outside of existing electronic databases to: assess feasibility of fit-for-purpose RWD; research natural history of diseases to understand background event rates in the indicated population expected with standard of care; perform statistical risk assessments; use historical clinical trial data and other data sources to contextualize potential safety issues for new medications; support benefit-risk assessments throughout the product lifecycle; design and conduct post-authorization safety activities, including rapid analytics for signal strengthening and formal required/committed evaluation studies, as part of Pharmacovigilance and Risk Management Plans.
  • Support efforts for the Office of the Chief Medical Officer (OCMO) and cross-sector collaborations, as prioritized.
  • Promote the use of standardized tools to support real world evidence generation across functions utilizing RWE as part of the Integrated Evidence Generation Plan.
  • Keep up to date with changes in the external environment, including working through professional society and public-private consortia to advocate as a subject matter expert, regarding RWE guidance/framework for regulatory decision making.

Requirements

  • A minimum of a Master’s degree in Epidemiology or related discipline is required.
  • A Ph.D. or M.D. in Epidemiology or related discipline is preferred.
  • A minimum of 6 years of Epidemiology research experience with a Master’s degree or a minimum of 5 years of Epidemiology research experience with a Ph.D. or M.D. is required.
  • Understanding of the epidemiologic landscape of specific diseases, conditions, or therapies is required.
  • Experience writing observational study protocols, proposals, and proposal requests, particularly the methods sections, is required.
  • Experience working with Health Authorities is preferred.
  • Understanding and ability to apply and interpret quantitative methods is required.
  • A minimum of 1 year of experience in statistical programming (e.g. R) is required.
  • A minimum of 1 year of database programming (e.g. SQL) in large healthcare databases is required.
  • Experience with developing R Shiny apps is required.
  • Product development experience in the pharmaceutical industry is preferred.
  • Knowledge of the Neuroscience therapeutic area is preferred.
  • A track record of authoring scientific communications (peer-reviewed publications, poster or oral presentations at conferences, technical reports) is required.
  • Must have excellent verbal and written communication skills.
  • The ability to collaborate with all levels in a global, cross-functional team environment is required.
Benefits
  • medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance
  • consolidated retirement plan (pension) and savings plan (401(k))
  • Vacation - up to 120 hours per calendar year
  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
  • Holiday pay, including Floating Holidays - up to 13 days per calendar year
  • Work, Personal and Family Time - up to 40 hours per calendar year

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
epidemiologyobservational study protocolsquantitative methodsstatistical programmingdatabase programmingRSQLR Shinyreal-world evidence (RWE)Pharmacovigilance
Soft skills
verbal communicationwritten communicationcollaborationconsultingpresentation skillsstakeholder communicationteamworkproblem-solvinganalytical thinkingadvocacy
Certifications
Master’s degree in EpidemiologyPh.D. in EpidemiologyM.D. in Epidemiology