Senior/Executive Medical Director
- Experience Level
The Executive Medical Director works with an international team of medical monitors and safety officers to ensure the medical/clinical integrity and quality of studies are conducted in compliance with all applicable competent authority regulations and international Good Clinical Practices (GCP). To serve as the medical contact in study protocols to investigators and study sites team regarding protocol compliance issues and safety of the subjects enrolled. Advises and assures investigators, project teams, and clients on safety issues arising from medicinal products, devices and study designs undertaken by Pharm-Olam. Work with internal team members, senior management and business development on issues and questions of any medical /clinical nature. Reviews SAEs, SUSARs and AEs reports in accordance with all applicable competent authority regulations and ICH E2 reporting standards. Ensure that protocols, investigator’s brochures, clinical trial reports written are appropriately reviewed and approved in accordance with SOPs and good medical practices.
- Oversee the safety aspects of assigned clinical trials managed including adverse events, safety reporting and laboratory testing. When appropriate, assist the Project Manager in discussions with clients on safety issues or concerns that may have arisen.
- Prepares the Medical Monitoring and other relevant Plans for studies conducted prior to the start of the study.
- Serves as the medical monitor contact in study protocols.
- Reviews IND safety narratives in accordance with FDA and ICH E2 reporting standards and oversees the processing of SAEs, SUSARs, etc. to clients and to regulatory agencies.
- Provide ongoing tutoring/medical education to DSOs (Drug Safety Officers), Regulatory, Clinical Operations personnel and other team members.
- Provides 24/7 monitoring coverage as required for the assigned protocols.
- Reviews and addresses all medical alerts setup for the safety of assigned projects.
- Reviews clinical laboratory data on selected studies for safety tends or signals detection.
- Assists clinical data management with MedDRA and WHO coding.
- Conducts the medical reviews of safety listings and clinical trial data in assigned studies.
- Assists by reviewing or writing safety section of a clinical study report (CSR) and other safety reports including post marketing reports (e.g., PSUR).
- Reviews Investigational Brochures, protocols or other study-related documents produced for accuracy, completeness and comprehension and to provide scientific input as needed.
- Assists in the set up and conduct of Data Safety Boards (DSMB, DMB or similar) as required .
- Assists with protocol interpretation and, as needed, contacts appropriate team members to ensure appropriateness of decisions arising from such interpretation.
- May advice and assist clients on product development, study designs, endpoint analyses and the feasibility of conducting Phase I to IV clinical trials in countries proposed. Liaise with country managers and department heads as needed to meet this task.
- With the assistance of the country manager, advises on federal and local laws, regulations or medical practices affecting the clinical trials managed. Where appropriate, maintains contact with various medical consultants.
- May provide therapeutic consultation in support of the scientific, medical and regulatory operations of the company, including medical assessments on a consultative basis for post marketing activities (e.g., product labelling, health hazard evaluations, etc.).
- Provide direction to the medical writing personnel and activities of the company.
- Attends and participates in Investigators’ meeting and other committees, meetings as requested.
- Attends and presents at major therapeutic conferences and drug development conferences.
- Supports the company’s growth through finding new clients and developing existing accounts in Business Development.
- Other duties as assigned.
- Typically reports to Chief Medical Officer.
- Works with Clinical Research Associates, Project Managers, ADPMs and other Departments (DM, Biostatistics, Regulatory, BD etc.) to support cooperative exchange of study and safety data.
- MD or DO Degree required.
- At least five years medical monitoring experience and/or relevant clinical research experience.
- Able to make medical decisions for the study independently and can act as primary medical monitor on assigned studies.
- Able to review relevant medical documentation to give assistance to Business Development.
- Previous experience within a clinical and research environment, preferably CRO.
- High level of Organizational and technology skills.
- High level of interpersonal and presentation skills.