Director of Clinical Development - 6-month contract.
The primary role involves overseeing medical aspects of clinical trials to ensure compliance with company standard operating procedures (SOPs), client directives, good clinical practices, and regulatory standards. Responsibilities include attending and presenting at investigator and sponsor meetings, providing medical consultations to clients, investigators, and project teams, as well as supporting business development initiatives. The position also entails conducting medical reviews and analyses of serious adverse events in clinical trials, as well as evaluating marketed product individual case safety reports (ICSRs) and periodic safety reports such as PBRER, PSUR, DSUR, and other client deliverables.
The director will manage all medical components of contracted tasks throughout the pharmaceutical product lifecycle. This includes ensuring that tasks assigned to the Pharmacovigilance Group are executed correctly and in accordance with relevant regulations and ICH guidelines. The director will provide medical consultation to team members, addressing all study-related medical inquiries, and will maintain clear communication with associates and clients to ensure proper adherence to procedures.
In terms of clinical trial support, the director will monitor safety variables, including adverse events, laboratory abnormalities, changes in patient medical status, and the evaluation of concomitant medications for protocol compliance. The role involves discussing medical concerns with principal investigators and clients to ensure that all safety issues are addressed effectively. Additionally, the director may assist in the writing and review of clinical study reports (CSRs), IND/NDA reports, signal detection reports, and other regulatory documents to ensure the accuracy and completeness of medical content.
Education and Experience: A medical degree (MD or equivalent) is required, with an active medical license preferred. Candidates must possess at least one of the following qualifications: clinical experience in the relevant specialty or sub-specialty, equivalent to two years; relevant clinical trial experience in a Contract Research Organization, pharmaceutical company, or as a principal investigator, equivalent to one to two years; or direct experience in safety and pharmacovigilance, equivalent to two years.
If you are interested in this role, please email me on vik.patel@arm-talent.com for more details.