Responsibilities:

• Lead and oversee Phase 1 and Phase 2 clinical trials in Immunology and Autoimmune indications.
• Provide operational leadership for study planning, start-up, execution, and close-out activities.
• Develop and manage clinical timelines, budgets, and resource plans.
• Serve as the primary operational point of contact for CROs, vendors, and clinical sites.
• Ensure clinical trials are conducted in compliance with ICH-GCP, FDA regulations, and applicable global regulatory requirements.
• Collaborate closely with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Pharmacovigilance, and Medical Affairs teams.
• Review and contribute to clinical protocols, informed consent forms (ICFs), clinical study reports (CSRs), and regulatory submissions.
• Oversee site selection, site initiation, monitoring strategy, and issue escalation and resolution.
• Identify operational risks and implement mitigation strategies to ensure trial success.
• Mentor and provide guidance to Clinical Operations staff and cross-functional team members.
• Support inspection readiness activities and participate in audits and regulatory inspections as needed.

$130,000 - $155,000 a year