Overview
Physician providing medical expertise to ensure timely planning, designing, conduct, monitoring, and reporting of clinical trials.
Responsibilities
What you will be doing:
1. Represent the Medical Leader Function of the CST.
2. Serve as the responsible physician for all medical aspects of clinical studies from Phase I to Phase III.
3. Contribute to trial oversight by monitoring participant safety and data integrity, as documented in the Medical Monitoring and Oversight Plan.
4. Review study-related listings and perform reconciliation.
5. Provide medical input in the selection of CROs and other vendors for the assigned clinical study.
6. Interact with medical counterparts at CROs and key opinion leaders.
7. Review CRFs and data management plans.
8. Assist in preparing regulatory documents for CTA submission, including Briefing documents, IB, IMPD, protocols, and ICFs.
9. Contribute to the writing and review of site guidelines, laboratory manuals, and other clinical study documents.
10. Provide training to CRAs, investigators, and trial personnel; act as the central contact for study-related medical questions.
11. Participate in safety risk identification and mitigation as a member of the safety management team.
12. Review and approve protocol deviations.
13. Define and review CAPAs.
14. Contribute to the generation of study results and review/approve SAP, mock TLFs, and CSR.
15. Participate in external communications and publications of study results.
Qualifications
You are:
* An MD with at least 7 years of experience in the pharmaceutical industry in a medical director role.
* Experienced in Immunology.
* Knowledgeable in Phase II–III drug development.
* A strong leader and strategic thinker.
* Energetic with a positive, can-do attitude.
* Having at least 3 years of medical practice experience.
* Proficient in English speaking and writing.
What ICON can offer you:
We prioritize building a diverse culture that rewards high performance and nurtures talent. Along with a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:
* Annual leave entitlements
* Health insurance options
* Retirement planning
* Global Employee Assistance Programme (TELUS Health)
* Life assurance
* Flexible benefits such as childcare vouchers, gym discounts, travel passes, and health assessments
Visit our careers website for more: https://careers.iconplc.com/benefits
ICON values inclusion and belonging, providing an accessible environment free of discrimination. If accommodations are needed during the application process or to perform job functions, please let us know through the provided form: https://careers.iconplc.com/reasonable-accommodations
We encourage all qualified applicants to apply, even if they do not meet every requirement.
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