Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Pharmacokinetics & Pharmacometrics
Job Category:Scientific/Technology
All Job Posting Locations:Spring House, Pennsylvania, United States of America
Job Description:We are searching for the best talent for our Scientist, Trial Support position, to be located in Spring House, PA. Remote work options may be considered on a case-by-case basis and if approved by the Company.
Purpose: The Scientist, Trial Support position is a clinical operations support role within Bioanalytical Discovery and Development Sciences (BDDS). We work with internal bioanalytical groups and external partners to ensure the completion of all activities related to clinical study data deliveries and sample management. We work to support all therapeutic areas within Johnson & Johnson, spanning non-clinical studies to post-market clinical development.
You will be responsible for:- Acting as a developing individual contributor in the execution of pharmacokinetic/pharmacodynamics (PK/PD) research projects to support development programs and research of the properties of drug candidates.
- Contributing to studies supporting the discovery, clinical candidate selection, development and approval of medicines.
- Participating in the completion of all activities related to Global Bioanalytical Discovery & Development Sciences (BDDS) clinical and nonclinical study deliveries. At times, assist with the completion of activities by other members of the group, to ensure timelines are met.
- Partnering with Global Clinical Development Operations Integrated Data Analytics & Reporting (GCDO IDAR), BDDS, Compliance & Data Integrity, the Central Laboratory, and the clinical trial teams when the bioanalytical sample management and data reporting requirements are established for a trial.
- Reviewing specifications documents from internal groups and Central Laboratories for studies where BDDS will be conducting analyses or reporting results.
- Defining studies in LIMS for clinical and nonclinical studies so that samples can be inventoried and analyzed.
- Delivering bioanalytical results to Global Clinical Development Operations Integrated Data Analytics & Reporting, Translational Research with BDDS, Global Clinical Pharmacology and/or CROs.
- Providing support with acquisition, storage, and disposition of clinical and nonclinical study samples.
- Generating status reports for sample data cleaning activities, and issues, relative to planned bioanalysis dates for multiple clinical studies, and/or for multiple external service providers.
- Participating in process and system optimization projects.
- Coaching more junior colleagues in techniques, processes and responsibilities.
- Understanding and applying Johnson & Johnson's Credo and Leadership Imperatives in day-to-day interactions with team.
Qualifications / Requirements:- Bachelor's degree with 3 years of relevant experience, Master's degree with 2 years of relevant experience or a PhD with 1 year of relevant experience is required.
- Sample management experience is required.
- Basic understanding and experience reviewing lab-based technical documents (e.g., Protocols, Statements of Work, and/or Lab Manuals) is required.
- Experience working in database systems (e.g., Watson LIMS, LabVantage LIMS, etc.) is required
- Good communication skills and ability to communicate effectively across all levels of the organization required.
- Good organization, attention to detail and time management skills required.
- Experience in areas of GLP/GCP is required.
#LI-HybridRequired Skills: Preferred Skills:Analytical Reasoning, Clinical Data Management, Clinical Pharmacology, Coaching, Data Savvy, Detail-Oriented, Drug Discovery Development, Pharmacokinetic Modeling, Pharmacokinetics, Pharmacometrics, Process Chemistry, Regulatory Environment, Relationship Building, Report Writing, Research Documents, Scientific Research, Study Management, Technologically Savvy
