Senior Director Clinical Development

Senior Director, Clinical Development – 37 hours per week - 6 months

This position is responsible for overseeing the medical aspects of clinical trials. The role ensures compliance with company standard operating procedures (SOPs), client directives, good clinical practices, and regulatory requirements.

The Senior Director will participate in investigator and sponsor meetings, provide medical consultations to clients, investigators, and project teams, and support business development initiatives. Additionally, the position involves reviewing and analyzing serious adverse events from clinical trials, as well as periodic safety reports and other client deliverables.

In this capacity, the Senior Director manages all medical components of contracted tasks throughout the pharmaceutical product lifecycle. It is essential to ensure that tasks assigned to the Pharmacovigilance Group are executed effectively while adhering to relevant regulations and ICH guidelines.

The Senior Director will also provide medical consultation to team members, addressing any study-related medical inquiries, and maintain clear communication with associates and clients to ensure compliance with established procedures. Training on therapeutic areas and study protocols may also be provided as needed. Furthermore, the Senior Director will monitor safety variables in clinical studies, including adverse events, laboratory abnormalities, and changes in patient medical status. Engaging in discussions with principal investigators and clinical teams regarding medical concerns is a critical aspect of this role. The Senior Director will also assist in the writing and review of various regulatory documents, ensuring that the medical content is both accurate and comprehensive.

This is a freelance project, where you can be based in any EU country, and it will be a 6-month project with scope to extend.