FierceBiotech and FiercePharma Jobs
Vice President, Endocrinology, Biopharmaceuticals - Pharma-Cruiting - Life Sciences Executive Recruiters
Categories: Clinical
Website: http://www.pharmacruiting.com
Position Description
We are seeking a Vice President, Endocrinology for our biopharmaceutical client in New Jersey.
Responsible for providing both clinical and scientific endocrinology expertise for the development of products within our client’s portfolio of products.
Provide clinical as well as scientific endocrinology expertise for the development of products within our client’s portfolio while managing the critical path toward product commercialization
• Provide high level medical and therapeutic guidance to internal and external customers including project teams, functional units, investigators and regulatory agencies
• Manage and direct clinical staff physicians with endocrinology and pulmonary expertise for the development of products within our client’s product portfolio
• Provide hands-on operational support to teams in clinical trial planning, protocol development, investigator selection, training of internal and external personnel, medical monitoring for trial safety and quality control
• Provide endocrinology expertise to clinical trials in the drug and device development process which includes the review and editing of protocols to ensure accuracy, consistency with standard of care, logistical ease and internal consistency within the company.
• Provide appropriate and consistent medical monitoring to ensure patient safety and adequate reporting and coding of adverse events in clinical trials
• Provide writing and editing of clinical reports for regulatory submission and updates while ensuring medical accuracy
• Provide direct physician support to quality assurance groups for review of product complaints, MDR reporting criteria, health risk assessments and product performance criteria
Required Skills
Requirements:
• Medical Degree (M.D. or D.O.) and current license to practice clinical medicine in Endocrinology, board certification preferred, board eligibility accepted
• Demonstrated knowledge of and capability of applying the science and methods of basic statistics to clinical study design considerations data analysis and to deriving descriptive data outcome conclusions
• Strong organizational knowledge and experience in regulatory processes and requirements (IND/CRF/GCP/NDA)
• Experience in writing scientific reports, authorship or co-authorship of scientific publications desirable
• Prior leadership experience including the management of professionals in a pharmaceutical environment
Please send your cover letter, resume and salary requirements to ruth@pharmacruiting.com


