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:
1. Attending and presenting at investigator and sponsor meetings.
2. Providing medical consultations to clients, investigators, and project teams.
3. Supporting business development initiatives.
4. Conducting medical reviews and analyses of serious adverse events in clinical trials.
5. Evaluating marketed product individual case safety reports (ICSRs) and periodic safety reports such as PBRER, PSUR, DSUR, and other client deliverables.
6. Managing all medical components of contracted tasks throughout the pharmaceutical product lifecycle.
7. Ensuring tasks assigned to the Pharmacovigilance Group are executed correctly and in accordance with relevant regulations and ICH guidelines.
8. Providing medical consultation to team members and addressing study-related medical inquiries.
9. Maintaining communication with associates and clients to ensure adherence to procedures.
10. Monitoring safety variables, including adverse events, laboratory abnormalities, and changes in patient medical status.
11. Discussing medical concerns with principal investigators and clients.
12. Assisting in the writing and review of clinical study reports (CSRs), IND/NDA reports, signal detection reports, and other regulatory documents.
Education and Experience: A medical degree (MD or equivalent) is required, with an active medical license preferred. Candidates should 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.
* Direct experience in safety and pharmacovigilance, equivalent to two years.
If interested, please contact via email at [emailprotected] for more details.
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