Associate Director, Clinical Operations (Site Operations)

TG Therapeutics, Inc.; North Carolina; On-site; USD 150,000 - 190,000; Full time

Job summary

The position focuses on Late Phase studies, PMRs, and real-world studies, with responsibilities to develop budgets, ensure compliance, and guide study operations leads. Strong leadership and CTMS experience are essential.

Qualifications

• 6+ years in clinical site start-up, ongoing site operations, and site close-out.
• Experience leading operational delivery of clinical trials; Phase 4, PMRs, and real-world studies preferred.
• Experience leading, coaching, and developing individuals and teams.
• Experience using metrics to identify risks and drive improvements.
• Experience with CTMS and document management/collaboration platforms.

Responsibilities

• Provide strategic leadership and oversight for Site Operations across the clinical portfolio.
• Partner with Manager, Site Operations to set priorities and improve execution.
• Develop site budgets templates reflecting protocol requirements and cost benchmarks.
• Develop and monitor Site Operations metrics to identify trends and risks.
• Evaluate and implement best practices and tools to improve efficiency and site experience.
• Provide guidance for complex cross-functional site operational issues.
• Collaborate with Clinical Ops and other functions to align site operations with study goals.
• Lead Study Operations Leads and oversee the growth of the team.
• Promote quality, compliance, sponsor oversight, and inspection readiness.
• Lead or contribute to strategic initiatives, audits, and regulatory inspections.

Skills

Leadership

Strategic thinking

Cross-functional collaboration

Problem-solving

Mentoring/People development

Communication

Education

University degree in life sciences

Tools

CTMS

Veeva CTMS

Job description

Legitimate TG Therapeutics job offers will only come from individuals whose email addresses end in @tgtxinc.com. TG Therapeutics only uses LinkedIn and our TG corporate website for job postings. TG Therapeutics does not use Flock or any other social media platforms other than LinkedIn.

Organizational Overview:

TG Therapeutics is a fully-integrated, commercial-stage, biopharmaceutical 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 has received approval from the United States Food and Drug Administration (FDA) for BRIUMVI (ublituximab-xiiy) in the US and European Commission.

Position:

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.

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.