Sr. Clinical Research Scientist - Pharmaceutical - North NJ
We are a publicly traded research-based pharmaceutical company and our purpose is to bring
diagnostic and therapeutic innovations to the healthcare community. We serve in the female
healthcare, diagnostic imaging, cardiovascular, neurology, oncology and dermatology markets.
CLIENT WILL RELOCATE FOR A QUALIFIED CANDIDATE
- Provide timely and scientifically sound Clinical Pharmacology (pharmacokinetic,
pharamcodynamic) input into Clinical Pharmacology Development Plans supporting the needs of
Global Medical Development..
- Plan, design and prepare study outlines, study protocols and final study reports.
- Develop and propose study budgets and logistical plans to facilitate the selection of
appropriate study sites.
- Coordinate the planning of Clinical Pharmacology studies, manage and coordinate the
preparation of study CRFs, study monitoring, study package tests, GCD roles, and the review of
data listing tables and final study reports.
- Coordinate with the study team document submissions, study conduct and reporting, clinical
data coordination and statistical analysis.
- Responsible for NDA and IND and interacting with global regulatory agencies regarding
clinical pharmacology aspects of assigned projects including preparation of required meeting
packages and representing company at such meetings/ interactions .
- Manage the contracted studies including data analysis review and compliance with SOPs.
- Plan, design and prepare Clinical Pharmacology sections of Global Submission documents.
- Perform state-of-the art analysis of phamacokinetic/pharmacodynamic data summaries using the
- Analyze and interpret complex pharmacokinetic and sophisticated pharmacodynamic data of
intra and extramural origin.
- Conduct computerized simulations using state of the art modeling software.
- Put together the study outline.
- Work with the clinical team lead, medical monitors statisticians, CRA's, data management,
sites, outsourcing who are responsible for managing the study.
- Full responsibility for pharmacokenetics and pharmacodynamics.
- Interact with CROs who conduct the study and lead the study teams.
- This is a global role and responsible for the compound globally.
- Travel is about 10-20% to scientific meetings