Our client is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
In collaboration with the clinical teams the primary role is to lead and execute early/late stage clinical trials for oncology products in the hematology/stem cell transplantation space in development. Participates in the design/planning of clinical studies and helps with the interpretation of study results. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. May recruit clinical investigators for research studies. Responsibilities also include adverse event monitoring/safety signal assessments and clinical trial safety responsibilities. Coordinates and develops reporting information for reports submitted to the FDA. Participates in investigator training, site training, advisory board preparation, protocol generation, clinical study report generation, etc. Monitors adherence to protocols and oversees study completion.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• 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
• Strong organizational and time management skills
Very competitive salary and benefits!
Great company to work for!
Full relocation package is available!
Don't miss out! Apply now and we'll be in touch immediately with more specific details, salary information and to answer any questions!!
This position does NOT provide sponsorship so please do NOT apply if you require sponsorship. Thank You
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