Latitude Inc ยท 3 weeks ago
Associate Director, Clinical Operations (Auto-Immune Experience)- Mostly Remote
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
$130K/yr - $155K/yrLatitude Inc is seeking an Associate Director, Clinical Operations to provide strategic and operational leadership for early-phase clinical trials in Immunology and Autoimmune therapeutic areas. This role involves overseeing clinical trial execution, ensuring compliance and quality, and collaborating with various internal and external teams to drive successful outcomes.
Manufacturing
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
Qualification
Required
Experience in leading Phase 1 and Phase 2 clinical trials in Immunology and Autoimmune indications
Strong operational leadership skills for study planning, start-up, execution, and close-out activities
Ability to develop and manage clinical timelines, budgets, and resource plans
Experience serving as the primary operational point of contact for CROs, vendors, and clinical sites
Knowledge of ICH-GCP, FDA regulations, and applicable global regulatory requirements
Ability to collaborate closely with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Pharmacovigilance, and Medical Affairs teams
Experience reviewing and contributing to clinical protocols, informed consent forms (ICFs), clinical study reports (CSRs), and regulatory submissions
Experience overseeing site selection, site initiation, monitoring strategy, and issue escalation and resolution
Ability to identify operational risks and implement mitigation strategies to ensure trial success
Experience mentoring and providing guidance to Clinical Operations staff and cross-functional team members
Ability to support inspection readiness activities and participate in audits and regulatory inspections as needed
Company
Latitude Inc
Company Summary Latitude is a Human Resource Consulting Firm headquartered in Hanover, MD with an office in Winter Park, FL.
Founded in 1990
11-50 employees
H1B Sponsorship
Latitude Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (4)
Funding
Current Stage
Early StageCompany data provided by crunchbase