Scientist 3 - Clinical Research

Title: Scientist 3 - Clinical Research -

Location: TITUSVILLE / NJ / 08560

Duration: 5 months (possible for extensions)

(REMOTE Position

Job Description:

Senior Scientist Clinical Research

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 and Reporting

Responsible for leading the translation of scientific concepts into program and study design

Responsible for identifying and implementing (non-medical) scientific aspects of the program and/or study at planning, execution and 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 and 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).

Education and Experience:

PhD in relevant field (e.g. Neuroscience, Biomedical Sciences, Biology; chemistry: pharmacy) , PharmD or MD degree from an accredited institution with 1-2 yrs. work experience; or Masters in relevant field with 2-4 yrs work experience