Position Summary:
We are seeking a highly motivated Medical Affairs Manager with demonstrated experience in providing operational and strategic support for global late-phase (Phase 4) research in the Oncology or other Therapeutic Area (TA). The successful candidate will support the planning and execution of late-phase and real-world evidence studies, including company-sponsored research and Investigator-Sponsored Research (ISR), in close collaboration with internal cross-functional teams and external stakeholders.
This role is ideal for professionals with a background in Clinical Development, Clinical Operations, or Medical Affairs, who are seeking to build upon their experience in phase 4 and real-world evidence research in a dynamic and global environment.
Key Responsibilities:
- Provide operational support for global late-phase oncology research programs, including interventional and observational studies.
- Actively contribute to the planning and execution of Phase 4 clinical trials, Real-World Evidence (RWE) studies, and ISR programs.
- Schedule meetings via Outlook and secure participation from key stakeholders.
- Prepare and distribute agendas, presentations, meeting minutes, and follow-up materials.
- Collaborate cross-functionally with Clinical Development, Regulatory, Legal, Compliance, and external partners to ensure alignment on study goals and timelines.
- Support development of study protocols, charters, and data dissemination plans in collaboration with scientific and medical leads.
- Monitor and track key operational metrics, timelines, and budget aspects of assigned projects.
Qualifications:
- Advanced degree (PhD, PharmD, MD, or equivalent required).
- 1–2 years of experience in Clinical Development, Clinical Operations, or Medical Affairs.
- Proven experience in managing operational aspects of clinical or observational research studies.
- Strong knowledge of clinical trial regulations, ICH-GCP guidelines, and ethical requirements.
- Exceptional project management, communication, and organizational skills.
- Ability to work effectively in a global matrix environment and across multiple stakeholders.
- Proficient in MS Office tools (Outlook, PowerPoint, Excel).
- Multiple therapeutic area experience strongly preferred.
- Experience working with global teams and stakeholders.