Vice President Clinical Development & Regulatory
Presenting a unique opportunity for a Vice President of Clinical Development & Regulatory Affairs. Our client is an emerging growth, innovative pharmaceutical company focused on the development and commercialization of oral sedation and anesthesia therapeutics for medical procedures in hospital, outpatient, and in-office settings.
Responsible for the strategy, design and execution of the clinical development program, the outstanding candidate will build a department of internal and external stakeholders that meets a high standard of ethics, scientific merit, and regulatory compliance, as well as satisfy the requirements for registration, approval and post-approval commitments of all relevant products.
Key responsibilities include managing the preparation and review of relevant IND documents, clinical development plans, reports and regulatory documents. This individual will interact with regulatory agencies and assume responsibility for responding to questions from the agency as well as applying for regulatory status for Breakthrough Therapy, Orphan Drug, Fast Track and/or Priority Review applications.
An MD preferably in disciplines related to anesthesia, pain management and/or sedation is sought with a minimum of 10 years of relevant experience in drug development and phased clinicals through regulatory submission of small molecules in the pharmaceutical or biotech industry.
The company is currently led by a CEO and board of entrepreneurial pharma veterans with a proven track record of founding & growing companies for exceptional value. The company possesses an entrepreneurial, collaborative culture where exceptional talent is sought and rewarded. The company offers a competitive compensation package and a highly attractive equity opportunity.