Associate Director, Clinical Operations (Auto-Immune Experience)- Mostly Remote

Position Summary: The Associate Director, Clinical Operations will provide strategic and operational leadership for early-phase clinical trials, with a primary focus on Phase 1 and Phase 2 studies within Immunology and Autoimmune therapeutic areas. This role is responsible for overseeing clinical trial execution from study start-up through close-out, ensuring timelines, quality, compliance, and budget objectives are met. The Associate Director will collaborate cross-functionally with internal teams, CROs, and external partners to drive successful clinical outcomes. This position is mostly remote with infrequent travel to Germantown, MD. 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.