Job Summary: The Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post registration. Responsibilities include the development of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies, conduct hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and Pharmacometrics/ Quantitative Clinical Pharmacology function. The incumbent will champion model-based drug development as an active team member of clinical and development teams.
Responsibilities: Responsible for all aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead; supports Phase 2/3 clinical pharmacology objectives with high-level supervision; participates in due diligence activities and represents global function on study and project teams.
Produces independent writing for publications & regulatory documents.
Serves as a specialist in PK-PD and Pop PK-PD concepts, phase 1-4 clinical studies, literature, and regulatory guidelines and can conduct/develop PK-PD and Pop PK-PD analyses.
Participates in KOL and regulatory interactions at project level, interacts with regional and global study and project team members, and to a limited extent with senior management, and outside vendors; works independently for all phases of studies.
Qualifications: Education: Bachelor's degree and Master's degree, MD or Ph.D.in pharmacology or pharmaceutical sciences, or a PharmD with a clinical pharmacology research fellowship.
Experience: 5+ years industry experience
Job Title Assoc Dir Clinical Pharmacology QCP
City Basking Ridge
Functional Area QCP
State New Jersey Associated topics: aseptic technique, cytometry, diet, food scientist, health, histology, immunology, kinesiology, protein, vaccine
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.