3 weeks ago
Princeton 0 - 0 Contract
The Associate VP or VP, Dermatology/Rheumatology will be responsible for all day-to-day aspects of the Dermatology and Rheumatology clinical drug development programs. He/ she will work in cross functional teams to assure the highest standards of clinical drug development. This person will be responsible for all medical aspects of regulatory communications documents, as well as the medical review of Dermatology/Rheumatology clinical trial data.
This individual must be able to communicate both verbally and in writing his or her medical expertise to guide the development and execution of clinical development plans, protocols, abstracts, and clinical trial reports for company clinical programs. This will involve a deep knowledge and understanding of Standard Operating Procedures, medical monitoring and the monitoring of competitor activities and data. He/she will serve as the key individual providing medical expertise and input into, including authoring of, the clinical development plans, protocols, abstracts, and clinical trial reports for all drug candidates. He/she will also contribute to pharmacovigilance review of clinical trial data as well as collect external data and competitive intelligence in select compound targets. Furthermore he/she will give clinical input in development activities related to the company pipeline and will serve as an internal resource for all functions requiring clinical input.
• Directing the development, presentation and publication of clinical data on the company’s therapeutic candidates, ensuring the highest quality and consistency with corporate strategy
• Manuscript writing of publications or other documents intended for external audiences
• Supervision of internal Medical Directors and external consultants if applicable
• Primary point of contact for clinical trial staff at study sites, as well as for regulatory, safety and clinical operations and other functions requiring clinical input
• Review safety data for clinical detection and prepare safety charters, DMC charters, or other specific management plans or manuals in a cross-functional team if not primary author
• Support or preparation of data interpretation and clinical trial reports
Education & Experience:
In terms of professional experience, we are seeking an individual who should possess significant experience in clinical development with publication in peer-reviewed journals. This person must have knowledge of clinical development, the FDA, international global clinical trial regulations and good clinical practices (GCP) guidelines. Preference will be given to candidates who have previous experience with drug development within the pharmaceutical or biotechnology industry, particularly at companies addressing dermatology