Provides medical expertise and medical support: global clinical trial programs, feasibility assessment, medical training, and medical/clinical input for the design and execution of study protocols and/or clinical development programs and other special studies. The medical monitor will ensure clinical trials are conducted according to Good Clinical Practice, federal and international regulations and good medical practice.
Primary Responsibilities and Duties:
• Provide medical input into the design of clinical development programs, study protocols, etc.
• Manage the development of clinical trials, including input into the planning, design, preparation, initiation, and execution of study protocols, and provide medical monitoring and medical expertise during the course and the analyses of clinical trials.
• Provide Investigator Sites with medical consultation, protocol and safety training, and guidance on protocol requirements and waiver requests.
- Answer safety related questions and respond to inquiries from IRB/IEC, IBC, DMC, etc.
• Ensure the medical and scientific quality of clinical trial protocols, case report forms, clinical trial reports, adverse event coding (MedDRA and/or WHO Drug), and ensure other required documentation is in compliance with project plans, federal regulations, GCP, and good medical practice.
• Research, evaluate and select investigators and study sites.
• Participate in the analysis and interpretation of study data and preparation of reports for FDA and other Regulatory Authorities as well as publications.
• Meet with FDA and other Regulatory Authorities as necessary.
• Interact with staff across functional areas to ensure execution of successful projects
• Maintain working knowledge of GCPs and regulatory requirements relating to clinical development and safety compliance with ethical, legal and regulatory standards.
• Participate in proposal, feasibility assessments and review of proposal/contracts of Contract Research Organizations for clinical operations or medical services.
• Participate in the review and reporting of Serious Adverse Event information.
• Secure and manage medical consultants for specific therapeutic areas when necessary.
• Maintain excellent relationships with investigators and key opinion leaders.
Education and Experience Typically Required:
Must possess an MD. Experience in oncology and/or gene therapy is highly preferred.
Minimum 4 years of clinical research experience in the Pharmaceutical/Biotech or Contract Research Organization industry as a Medical Director (Associate) / Medical Monitor or equivalent in support of clinical trials.
Proven influence management and ability to identify potential hurdles and solutions that may impact the success of clinical trials.
Excellent interpersonal, communication and leadership skills and proven ability to work in a dynamic environment and manage competing priorities.
Proven presentation skills in public at scientific conferences, external organizations, advisory boards, etc.
High attention to detail and accuracy
Strong computer skills (MS Office)
Ability to travel up to 50% to clinical sites, investigator meetings, conferences, etc. including international travel.