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 Scientist
Responsible 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 vendors
Job Responsibilities
Program/Trial Planning, Execution & Reporting
Responsible for leading the translation of scientific concepts into program & study design
Responsible 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), imaging
Accountable for shaping and implementing compound and program DEI strategy together with Clinical Leader
Provides expert input in clinical development plans
Contributes 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 meetings
Reviews medical and scientific literature
Along with SRP or Clinical Leader and global development partners, responsible for oversight and high-quality implementation and closure of the study, ensuring data integrity
Responsible for the TA review and sign off on various operational plans
Responsible 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 aspects
Works closely with Data Sciences, Data Management, Statistics, Programming, JJIT and others to ensure data are received in the manner needed to support trial outcomes
Responsible for the review of the data to ensure quality and to identify data quality trends.
Sets up and leads Adjudication Activities
Leads data visualization (DV) meetings and ensures decisions are documented and communicated internally and externally
Owns 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 trials
Contributes to completion of clinical study reports
Contributes 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 Responsibilities
Partners with Regulatory Affairs in developing regulatory strategy and determining requirement for health authority reporting or corrective actions on trial/program level
May help explore and evaluate new assets (BD) and/or products to support compound value
Safety Management
Oversees the set-up of medical review tools to meet medical review plan requirements
Participates in Data Review Meetings
Qualified CS may perform aspects of medical review under supervision of CL or SRP
Safety monitoring summaries linked to quarterly medical reviews and/or monthly medical reviews may be delegated to qualified CS
Assists in organizing content for IDMC presentation
External Communication & Publication
Contributes in all areas where scientific data will be generated and shared with the patients and/or the scientific community
May be asked to assess medical publications emerging from the Team and its affiliates
May 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 Required
PG30: 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 experience
Experience 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 Practice
Energy 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.