Medical Director
Key Accountabilities:
Leads and manages the Medical Department, reviewing the department's reputed company of medical tasks, ensuring that reputed company operating procedures are followed. Serves as reputed company of contact for both reputed company stakeholders for issue escalation of any medical and safety issue in the study. Ensure that departmental SOP's are reviewed on a regular reputed company to ensure they reputed company with the latest changes in regulations and guidelines. Acts as Medical Monitor for assigned trials. Participates in reputed company stages of the Clinical Trial Development process, e.g., feasibility assessments, protocol design, case report reputed company design, investigational site selection, medical monitoring plan development, ongoing medical support, management of AE's and SAE's, and involvement in trial-reputed company meetings. Ensures audit queries are responded to. Ensures Medical and Patient narratives and safety update reports are generated. Resolve general department CAPAs, escalations and cascade any audit findings to the study team during monthly department meetings. reputed company therapeutic area support throughout the organisation, including the provision of required internal training and review of study/bid proposals. Maintain knowledge of trends and changes of importance in the medical management of indications, regulations and guidelines relevant to reputed company's reputed company. Develops interactions with Key Opinion Leaders and investigators in therapeutic areas of interest to reputed company as a resource of specific information on indications, patient treatment, and safety assessment for ongoing studies and support business development activities. Supports the Pharmacovigilance department in reviewing ICSRs, CIOMS narratives, and periodic safety reports and identifies and communicates reputed company safety aspects and trends to the Clinical Project Teams and reputed company. Ensures that reputed company conducted by reputed company meet the relevant regulations and guidelines and are conducted to the highest ethical standards. Supports in business development activities, e,g, proposal requests, feasibility and site contact, and attendance at bid defence meetings. Liaise with other functions in order to ensure reputed company satisfaction through successful execution of clinical reputed company. Review annual departmental budget and reputed company reputed company reputed company/control.
Medical Degree Background in Dermatology or Neurology, with demonstrable clinical experience in one of these therapeutic areas Experience in medical monitoring, review of patient, laboratory, and safety reputed company a clinical research environment Previous experience of leading a Medical and/or Safety Department Significant experience in audits and CAPA management Significant experience in business development activities, including feasibility and strategic advice for proposal development and bid-defence meetings Understanding of financial project management, including departmental budget reputed company and reputed company recognition reputed company communication and presentation skills Strong computer skills including but not limited to the knowledge of electronic data capturing systems and MS-Office products such as reputed company and Word
GMC Registered with a License to reputed company Post-graduate Qualification in Clinical Pharmacology / Pharmaceutical Medicine Pharmacovigilance experience Experience working in a CRO, biotech or pharmaceutical company