DEEPLY COMMITTED TO PATIENTS

Title: Associate Director, Clinical Operations (Site Operations)

Location: North Carolina

If you are interested in the below position, please send your resume to [email protected] and REFERENCE THE POSITION TITLE within the subject line.

Organizational Overview

TG Therapeutics is a fully integrated, commercial stage, biotechnology company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for BRIUMVI® (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by several foreign nations for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features. For more information, visit www.TGTherapeutics.com.

Role

The Associate Director, Clinical Operations provides strategic leadership and oversight for the Site Operations function, supporting effective and consistent site start-up and ongoing site operations across the clinical portfolio. This role partners closely with the Manager, Site Operations to strengthen operational performance, establish and monitor meaningful metrics, identify trends and opportunities for improvement, and implement industry best practices. The Associate Director provides guidance and support on complex issues and helps ensure the function has the capabilities, tools, and resources needed to effectively support study teams and investigative sites.

This role also provides operational oversight for Late Phase studies, including Phase 4, post-marketing requirements (PMRs), and real-world studies.

Key Responsibilities

• Provide strategic leadership and oversight for the Site Operations function, including site start-up and ongoing activities related to essential documents, IRB submissions, site-specific informed consent forms, site budgets and contracts, safety notifications, study communications, and site closeout.
• Partner with the Manager, Site Operations to establish priorities, strengthen team capabilities, and support consistent and effective execution across studies.
• Develop study-specific site budget template ensuring protocol requirements, study assumptions, site cost benchmarks, and operational considerations are appropriately reflected.
• Develop and monitor Site Operations metrics and performance indicators to identify trends, risks, bottlenecks, and opportunities for improvement.
• Evaluate and implement best practices, tools, and approaches that improve efficiency, quality, consistency, and the site experience.
• Provide guidance and escalation support for complex or cross-functional site operational issues.
• Partner with Clinical Operations and other functions to anticipate site operational needs and ensure Site Operations strategies support study and portfolio objectives.
• Provide operational oversight for Late Phase studies and guidance to assigned Study Operations Leads; serve as Study Operations Lead for select studies, as needed.
• Lead and develop direct reports and support the continued development and growth of the broader team.
• Promote quality, compliance, sponsor oversight, and inspection readiness across assigned responsibilities.
• Lead or contribute to Clinical Operations strategic initiatives, process improvement projects, audits, and regulatory inspections.

Professional Experience/Qualifications

• Strong expertise (e.g. 6+ years) in clinical site start-up, ongoing site operations, and site close-out.
• Demonstrated experience leading the operational delivery of clinical trials; experience with Phase 4, post-marketing, and/or real-world studies preferred.
• Demonstrated experience leading, coaching, and developing individuals and teams.
• Experience using metrics, trends, and performance data to identify risks and drive operational improvements.
• Demonstrated ability to identify and implement best practices and process improvements within Clinical Operations.
• Strong leadership, communication, problem-solving, and cross-functional collaboration skills.
• Ability to provide strategic direction while effectively managing competing priorities in a dynamic environment.
• Experience with clinical trial systems and technologies, including CTMS and document management/collaboration platforms; Veeva CTMS experience preferred.

Education

• University degree in life sciences or related fields.

Applicants must be currently authorized to work in the United States on a full-time basis. The company does not sponsor employment visas for this position.

TG Therapeutics is an equal employment opportunity employer, and does not discriminate on the basis of race, color, religion, gender, sexual orientation, gender identity or expression, age, disability, national origin, ancestry, genetic information, military or veteran status, pregnancy or pregnancy-related condition or any other protected characteristic.