Clinical Scientist

Are you looking for your the next step in your career? Kelly FSP is seeking a Clinical Scientist with a background in Neurology to join us to partner with one of our pharmaceutical clients in Titusville, NJ. This position is a hybrid model requiring a minimum of one day on site weekly.

Clinical ScientistResponsible for the translation and implementation of (non-medical) scientific concepts into the study design and/or program across planning, execution, and reporting, including integration of biomarkers, digital technologies, data science initiatives, and select vendorsJob ResponsibilitiesProgram/Trial Planning, Execution & ReportingResponsible for leading the translation of scientific concepts into program & study designResponsible for identifying and implementing (non-medical) scientific aspects of the program and/or study at planning, execution & reporting, including (but not limited to) integration of Biomarkers and Data Science/Digital Health initiatives into studies.Oversees the assessment, selection and operational implementation for biomarkers, digital and other endpoints (scales), imagingAccountable for shaping and implementing compound and program DEI strategy together with Clinical LeaderProvides expert input in clinical development plansContributes to the preparation of PED, study protocols and training materials for clinical studies.Prepares for and participates in Protocol review Committee (PRC) and First in Human (FIH) Committee meetingsReviews medical and scientific literatureAlong with SRP or Clinical Leader and global development partners, responsible for oversight and high-quality implementation and closure of the study, ensuring data integrityResponsible for the TA review and sign off on various operational plansResponsible for scientific input into HA and EC responses.In concert with operational staff, acts as a liaison between the company and clinical investigators for overarching scientific guidance and other potential non-medical aspectsWorks closely with Data Sciences, Data Management, Statistics, Programming, JJIT and others to ensure data are received in the manner needed to support trial outcomesResponsible for the review of the data to ensure quality and to identify data quality trends.Sets up and leads Adjudication ActivitiesLeads data visualization (DV) meetings and ensures decisions are documented and communicated internally and externallyOwns contracting with clinical consultants, IDMC members and KOLs, including payment oversight.Participates in vendor oversight focusing on the integration of data and technology in clinical trialsContributes to completion of clinical study reportsContributes to the interpretation, reporting and preparation of oral and written results of product research in concert with senior clinical personal, in preparation for health authority submissions.Additional Clinical Research ResponsibilitiesPartners with Regulatory Affairs in developing regulatory strategy and determining requirement for health authority reporting or corrective actions on trial/program levelMay help explore and evaluate new assets (BD) and/or products to support compound valueSafety ManagementOversees the set-up of medical review tools to meet medical review plan requirementsParticipates in Data Review MeetingsQualified CS may perform aspects of medical review under supervision of CL or SRPSafety monitoring summaries linked to quarterly medical reviews and/or monthly medical reviews may be delegated to qualified CSAssists in organizing content for IDMC presentationExternal Communication & PublicationContributes in all areas where scientific data will be generated and shared with the patients and/or the scientific communityMay be asked to assess medical publications emerging from the Team and its affiliatesMay act, in concert with senior clinical personnel, as the company spokesperson regarding publication of clinical research findings. This may include presenting research results at internal/external meetings (i.e. investigator meetings and company sponsored events)

Specific Skills, Capabilities, and Knowledge RequiredPG30: PhD in a relevant field (e.g. Neuroscience, Biomedical Sciences, Biology; chemistry: pharmacy), PharmD or MD degree from an accredited institution) with 2-4 yrs work experience; or Masters with 4-8 yrs work experienceExperience in clinical research/drug development that has exposed the individual to the rigors of human trial conduct with pharmaceuticals, devices, basic clinical practice with the precepts of Good Clinical PracticeEnergy and enthusiasm are essential.Experience in Neurology, Psychiatry or Neuroscience is strongly preferred.Clinical research operational knowledge, strong project planning/management and excellent communication skills are required.Ability to operate with limited day to day supervision is required.Independent decision-making and analytical skills are required.Successful work experience in a (virtual) matrix team environment with cross functional teams is required.Travel up to 20% of time both domestic and international is required.