Associate Director, Clinical Study Lead

🔥 39 minutes ago

🇺🇸 United States – Remote

💵 $180k - $210k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 0%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Immunic Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2016

🏥 Healthcare

💼 Consulting

⚖️ Legal

Healthcare • Consulting • Legal

Immunic Therapeutics is a late-stage biotechnology company focused on developing novel, orally administered small-molecule therapies for chronic inflammatory and autoimmune diseases, with particular programs targeting multiple sclerosis and celiac disease. The company advances differentiated clinical-stage programs (e. g. , vidofludimus calcium, IMU-856, IMU-381) aiming to provide efficacious, safe, and well-tolerated oral treatment options for neurologic and gastrointestinal immune-mediated conditions, while pursuing regulatory protections and commercialization pathways.

📋 Description

• Provide operational leadership for planning, start-up, conduct, maintenance, and close-out of assigned global studies or regions • Serve as principal Clinical Operations representative on cross-functional study teams and sub-teams • Communicate operational status, risks, assumptions, dependencies, and recommendations • Develop, review, and maintain study execution plans, regional and country strategies, enrollment plans, oversight plans, monitoring plans, study manuals, and operational trackers • Contribute operational input to protocols, informed consent forms, eCRFs, investigator materials, clinical study reports, and other study documents • Lead or oversee country and site feasibility, identification, qualification, selection, activation, training, enrollment, maintenance, and close-out • Contribute to CRO and vendor selection and oversight, including scope definition, contracting support, governance, issue resolution, change control, invoice review, and reconciliation • Monitor study and vendor performance using KPIs, quality indicators, milestones, forecasts, and dashboards; implement corrective actions and escalate material issues • Identify and manage operational, quality, timeline, budget, and compliance risks • Provide inputs to timelines, budgets, accruals, resource forecasts, enrollment forecasts, clinical supply forecasts, and scenario planning • Coordinate investigator meetings, site communications, training, and engagement activities • Ensure sponsor oversight documentation is inspection-ready, including eTMF, essential documents, monitoring deliverables, deviations, CAPAs, and study correspondence • Ensure database-lock readiness, document reconciliation, site and vendor closure, final payments, archiving, and Clinical Operations content for clinical study reports and appendices • Support audits, inspections, and health-authority interactions • Provide technical guidance, coaching, and mentoring to junior Clinical Operations team members • Contribute to departmental standards, tools, and process improvements • Act as backup for the Global Clinical Study Lead or other study leadership roles

🎯 Requirements

• Bachelor's degree or higher in nursing, life sciences, health sciences, or a related discipline; equivalent education and relevant clinical research experience may be considered • Typically 7+ years of pharmaceutical, biotechnology, or CRO experience • At least 6 years of clinical research experience with increasing responsibility • Experience managing Phase 1-3 clinical studies or substantial regional components from start-up through close-out and clinical study report delivery • Experience in a fully or substantially outsourced operating model, including CRO and specialist vendor selection, contracting, oversight, and performance management • Strong working knowledge of ICH-GCP, FDA, EMA, and local regulatory requirements • Knowledge of sponsor oversight expectations, inspection readiness, and clinical quality management principles • Ability to manage complex timelines, budgets, risks, priorities, and cross-functional dependencies in a global matrix organization • Strong analytical, organizational, and problem-solving skills • Excellent written and verbal communication skills in English • Ability to work independently in a dynamic, flexible, and innovative environment while managing multiple responsibilities under pressure • Willingness and ability to travel domestically and internationally based on study needs • Must be authorized to work in the US

🏖️ Benefits

• Equity • Bonus • Remote work arrangement • Opportunity to work with global clinical operations teams

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume