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.
$130,000 - $155,000 a year