Objectives/Purpose:
The PDT BU R&D group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases.
The PDT BU R&D group is seeking to hire a Senior Clinical Scientist contractor to support the maintenance of marketed products. Responsibilities will include but not be limited to support of regulatory filings, regulatory correspondence, and preparation of reports.
A minimum of 3-5 years of drug development experience is required. Experience with developing products for bleeding disorders is desired.
The incumbent’s will contribute to guiding a multi-disciplinary, multi-regional, matrix team through highly complex decisions.
This individual has responsibility for integrating the input from various disciplines to create, maintain, and execute a global plans for product maintenance and geographic expansion.
Requirements:
• Minimum of 3-5 years experience with clinical research drug development in a pharmaceutical, or biotech industry.
• Master’s degree required, advanced university degree preferred.
• Knowledge of clinical research discipline and GCP.
• Excellent verbal and written communication skills.
• Presentation, organizational and interpersonal skills are a requirement.
• Confident decision-making, and ability to work affectively as a team leader, team member or individually.
• Interest in application of clinical/medical knowledge in drug development
