Medical Lead - Translational - Clinical Pharmacology
Edison-New Brunswick Metro Area, NJ
- Clinical Pharmacologist - MD or PhD with At least 3 years experience in pharmaceutical/biotech company, CRO, or related clinical research/trials
- Specialized training in clinical pharmacology or experience working in the field of clinical pharmacology.
- Specialized training in Translational Medicine of clinical research experience in the relevant therapeutic area.
- Good knowledge of Good Clinical Practice.
- Track record of successfully managing multiple Phase 1 or clinical pharmacology trials concurrently.
- Experience in managing external relationships in clinical research setting.
- Implementation of strategies for assigned drug development projects in liaison with appropriate line functions and leading clinical pharmacology (CP) studies that meet regulatory requirements (ICH/GCP, SOPs/NIPs).
- Provide medical and scientific expertise to drive success of fully outsourced clinical pharmacology studies and implement strategies to achieve timely delivery of CP data for regulatory submissions with good quality.
- Develop and implement study concept sheet for different types of clinical pharmacology PK studies in Full Service Outsource Model (FSOM).
- Responsible for clinical monitoring and safety data review during and after the study.
- Provide medical and scientific leadership and expertise to all line functions on the FSOM study team.
- Lead the oversight of study analysis, data interpretation at the CRO partners and communication of the results internally.
- Oversee publication and external presentation of study results.
- With support from project Translational Medicine Expert (TME) and Therapeutic Area (TA) Heads, participate in selection of FSOM clin pharm studies according to the CP and profiling plan for the project. Together with the project TME may represent Translational Medicine (TM) on Global Project Team (GPT) communications.
- Act as an effective representative to external partners on medically related questions and issues.
- Recognized expert in clin pharm, drives project team clinical strategy. Works globally across Divisions, as well as therapeutic areas.