Role responsibilities (typical day):
- Serve on the Clinical Study Team and Global Clinical SubTeam; attend and actively participate in study team meetings.
- Contribute to program team meetings, scientific advisory boards, study steering committees, and data/safety monitoring meetings; collaborate with other departments.
- Apply basic scientific expertise to support execution of clinical research and development studies (early and/or late stage).
- Maintain understanding of therapeutic disease area(s), drug candidate (disease biology, clinical manifestations, standard practice, mechanism of action).
- Assist with trial documentation (medical monitoring plans, SAPs, informed consents, Clinical Study Report clinical components, regulatory documents) and provide scientific guidance.
- Ensure compliance with FDA/EMEA/ICH/GCP and applicable SOPs regarding clinical safety.
- Support preparation for external/stakeholder meetings (IM, Governance, DMCs, Regulatory Authority).
- Support clinical/medical data review (safety monitoring and patient safety).
- Identify data trends/inconsistencies and raise issues; support risk identification and mitigations.
Role may be for you if:
- Basic knowledge of drug development process, GCP, study design, and clinical research methodology; beginner-level medical writing.
- Ability to influence within the study team; strong management, interpersonal, and problem-solving skills.
- Independent resolution of most issues; ability to raise highly complex/out-of-policy issues.
- Proven track record in clinical trial process improvements; cross-functional experience.
Qualifications:
- BS/MS/PhD/PharmD in a related area.
- β₯ 6 years of pharmaceutical clinical drug development experience.
- Experience in immune/inflammatory related clinical trials.
- Basic knowledge of clinical development process, regulatory requirements, and ICH/GCP.
Application instructions:
- Apply now to take your first step toward living the Regeneron Way.