MEDICAL DIRECTOR - TRANSLATIONAL MEDICINE –
CLINICAL PHARMACOLOGY Mission Statement:
This key role is with a global Bio-Pharmaceutical company that conducts research, clinical studies and product registrations in the USA and in Europe. This Company develops and delivers new therapies in a variety of therapeutic areas (Oncology, Neurology, etc.) for patients around the world. Because of continued expansion, we are currently engaged in a search for an exceptional candidate as Medical Director of Experimental Medicine who will work under the direction of the Vice President of Clinical Development and Clinical Pharmacology. Responsibilities:
• Guide the development of standardized working practices for clinical design and conduct of Translational Medicine Phase 1 / Phase 2A studies across all projects to ensure integrity of clinical outcomes used in the decision process.
• Collaborate and assist in overseeing CROs involved with conduct and analysis of Early Clinical Development studies.
• Guide the development of standardized working practices for clinical design and conduct of Early Clinical Development studies across all projects to ensure integrity of clinical outcomes used in the decision process.
• Direct responsibility for study protocol writing
• Ensure that Phase 1 programs provide appropriate data for an efficient and timely transition to clinical PoC and/or full development.
• Collaborate and work with teams to include Pharm/Tox, PK, Clinical and Regulatory both in the US and in Europe. Qualifications:
• MD or MD PhD and 3+ years of industry experience (preferably in clinical pharmacology),
• Previous responsibility for design and conduct of Phase 1 / Phase 2A study protocols.
• Experience across multiple therapeutic areas is very desirable.
• Ability to work with minimal supervision to identify, prioritize and resolve problems.
• Ability to work effectively in a team environment.
• Strategic orientation with evidence of implementation and oversight of novel methodological approaches coupled with a strong focus on set up and conduct of exploratory clinical studies.
Experience in issues around design and conduct of Phase 1 /Phase 2A studies, and in regulatory and pre-clinical issues.
• Familiarity with ICH, FDA and GCP guidelines governing clinical trial design and conduct, biomarkers, pharmacogenomics and clinical technologies. | 