PK/PD Trial Support Scientist

6084-Janssen Research & Development, LLC Legal Entity

Spring House (PA)

Hybrid

USD 90,000 - 130,000

Full time

14 days+

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Job summary

Johnson & Johnson is seeking a Scientist, Trial Support in Spring House, PA to support clinical study data deliveries and sample management within Bioanalytical Discovery and Development Sciences. You will work with internal bioanalytical groups and external partners to ensure timely, compliant study data delivery.

The role requires a Bachelor's with experience or higher, strong communication, organization, and GLP/GCP knowledge.

Qualifications

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.

Responsibilities

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.