Clinical Trial Manager, Immunology

🔥 1 hour ago

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SAB BIO

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2014

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

SAB BIO is a clinical-stage biopharmaceutical company focused on developing multi-specific, high-potency human immunoglobulin G (hIgG) therapies to treat and prevent immune and autoimmune disorders, with a stated mission to redefine diagnosis and treatment of type 1 diabetes (T1D) through disease-modifying medicines. Founded in 2014 and traded on Nasdaq (SABS) since 2021, SAB BIO uses proprietary genetic engineering and antibody technologies to generate therapeutic candidates without relying on human donors or convalescent plasma. The company has conducted seven clinical trials dosing roughly 700 individuals across multiple therapeutic areas, reporting no patients with serum sickness or neutralizing anti-drug antibodies in its safety and immunogenicity database. Its lead candidate, SAB-142, is aimed at delaying onset and potentially preventing progression of Stage 3 T1D.

📋 Description

• Oversee the planning, implementation and management of clinical trials to ensure they are conducted efficiently, ethically, and in compliance with regulatory guidelines • Lead the design and implementation of clinical trial protocols, including site selection, patient recruitment strategies, and timeline development • Manage all aspects of clinical trial operations, ensuring adherence to timelines, budgets, and regulatory requirements • Establish and maintain strong relationships with clinical trial sites • Monitor trial progress, ensuring accurate data collection, timely reporting, and adherence to Good Clinical Practice (GCP) guidelines • Identify potential study risks and develop mitigation strategies to ensure successful trial outcomes • Prepare and present updates to stakeholders, including internal teams and external partners

🎯 Requirements

• B.S. degree with minimum 6-8+ years of experience managing clinical trials in biotech, pharmaceutical • Strong clinical study conduct experience from start-up through close-out, with global trial and CRO management experience • Experience with phase II, III study oversight and management • Experience with timeline management • Strong leadership, effective decision making, and problem-solving skills required • Document reviews in relevant systems with a focus on inspection readiness • Working knowledge of relevant GCPs and FDA, EMA and MHRA regulations • Demonstrated experience using various EDC, CTMS and eTMF (Veeva, Agatha) systems • Experience with operational financial tracking systems a plus • Demonstrated proficiency using MS Office applications, including MS Word, Excel, PowerPoint • Experience using Smartsheet • Ability to work effectively with minimal supervision and multi-task activities to effectively manage deliverables across all trials • Excellent written and verbal communication skills

🏖️ Benefits

• Travel up to 25% • Reasonable accommodations in compliance with the Americans with Disabilities Act of 1990 • Equal Opportunity Employer