$200K — $250K *
• Support the establishment of clinical trial strategies for oncology products in development.
• Design, prepare and initiate study protocols and other required documentation in compliance with project plans, federal regulations, GCP and good medical practice.
• Act as medical monitor for company sponsored trials.
• Support project teams with therapeutic area specific information.
• Collaborate with internal safety group in analyzing and reporting of safety data from clinical trials.
• Analyze and interpret other clinical trial data and prepare reports for regulatory agencies and publication.
• Interact with key opinion leaders and investigators in relevant disease specific area.
• Ensure consistency of scientific and development strategies for oncology products in development.
• Maintain the highest level of scientific and clinical /clinical trial outcomes knowledge in relevant disease specific area.
• May supervise employees, both directly and indirectly through a dotted line structure; responsibility working with Clinical Research Organizations and other internal support groups.
• MD with board certification or eligibility in Oncology or Hematology/Oncology, or related specialty.
• Five to seven years of drug development experience in biotechnology or pharmaceutical industry, or a combination of academia and industry. Note: Individuals with extensive academic experience including clinical trial work but without experience in the pharmaceutical industry may be considered.
• Hands-on experience in the design, execution, and reporting of early stage and controlled clinical trials in oncology.
• Participated in clinical oncology studies with molecular targeted or immunological therapies.
• Understanding of basic science relevant to clinical oncology (biochemistry, immunology, molecular biology and/or genetics).
• Proven ability to effectively work in a cross-functional/matrix environment
• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
• Develops technical and/or business solutions to complex problems.
• Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
• Leads or manages the work of others by providing guidance to subordinates based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
• Ability to develop and maintain relationships with significant key opinion leaders.
• Strong interpersonal, influencing, presentation, and written and verbal communication skills
Valid through: 12/7/2020