In search of a physician career change opportunity or a new non-clinical career? An executive search firm is looking to fill the position of Director, Experimental Medicine, for their client, a pharmaceutical company located in north-central New Jersey.
Responsibilities:
* Ensure effective, scientifically sound, medically appropriate and consistent design and conduct of Phase 1 studies especially for compounds with novel or unknown mechanism of action.
* Collaborate with preclinical research during IND-enabling phase of drug development to facilitate effective translation of compounds into the clinic and timely filing of high quality IND/CTA dossiers.
* Provide feedback to preclinical research on the clinical outcomes of Translational Medicine Phase 1 studies.
* Represent the Translational Medicine & Clinical Pharmacology Department on Global Product Development.
* Oversee study protocol writing, clinical conduct and medical monitoring of these studies.
* Oversee the collaboration of Experimental Medicine with supporting functions such as Study Logistics, Data Management and Biostatistics to ensure timely data base lock, analysis and reporting of Translational Medicine Phase 1 studies within the project timelines.
* Collaborate with Global Product Development Teams during the IND-enabling phase of drug development to ensure timely submission of high quality IND/CTA dossiers for compounds entering the clinic.
* Guide the development of standardized working practices for clinical design and conduct of Translational Medicine Phase 1 studies across all projects to ensure integrity of clinical outcomes used in the decision process.
* Collaborate with TMCP functions on identification of Phase 1 units and other CROs involved with conduct and analysis of Translational Medicine Phase 1 studies.
* Ensure that biomarkers, pharmacogenomic and clinical technology endpoints are correctly incorporated in Translational Medicine Phase 1 studies.
Qualifications:
MD and or MD/ PhD. 5+ years of academic or pharmaceutical industry experience (preferably in clinical pharmacology) with 3+ years in a role having responsibility for design and conduct of Phase 1 study protocols. Experience across multiple therapeutic areas is very desirable.
Must have experience in issues around design and conduct of Phase 1 studies, and in regulatory and preclinical issues. Familiarity with ICH, FDA and GCP guidelines governing clinical trial design and conduct, biomarkers, pharmacogenomics and clinical technologies. 20% travel.
Highly competitive remuneration including base salary, benefits, bonus and incentives.
If you are interested in this position, please email your CV and a cover letter to info@prnresource.com, and we will forward them to the executive search firm looking to fill the position.
BR 7-08
