Dir. Legal

Location: Remote

If you are interested in the below position, please send your resume to careers@tgtxinc.com and REFERENCE THE POSITION TITLE within the subject line.

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 U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. TG Therapeutics is headquartered in Morrisville, North Carolina. For more information, visit www.tgtherapeutics.com.

Role

The Director, Legal -Technical Operations and Contracting, is primarily responsible for managing legal issues arising from TG’s Technical Operations team including Supply Chain, Quality, CMC Regulatory, Analytical Services, Manufacturing Science and Technology and Program Management Groups, focusing on product development and commercialization. In addition, the Director is responsible for the implementation, maintenance and operations of a Company-wide contracting process/system. TG is a virtual company so all Biologics Operations and Quality work is outsourced; this individual will work with both the internal team and outside contractors. This role involves drafting, reviewing, and negotiating CMC and Quality-specific contract terms, ensuring compliance with regulatory requirements and internal policies. This position provides contractual guidance, manages risks, and coordinates with internal departments like corporate legal, finance, technical operations, program management and quality to maintain effective contract lifecycles for CMC-related projects. This position is remote and may include international travel as needed.

Key Responsibilities

• Contract Process/System Management: Implement and maintain Company-wide CLM system. Collaborate with Procurement and business teams to streamline the contracting process, maintain templates and ensure alignment with company policies.
• Contract Lifecycle Management: Manage the entire lifecycle of contracts related to CMC and Quality, from initial drafts to execution, renewal, and closure.
• Drafting & Review: Draft, review, and revise complex legal documents, including proposals and non-standard agreements, with a specific focus on CMC and Quality requirements and regulatory implications.
• Negotiation: Participate with Supply Chain and other operational groups in development of Business Terms and subsequent contract negotiations, ensuring terms are fair, benefit the company, and minimize legal and financial risks.
• Risk Management: Identify, assess, and mitigate contractual and regulatory risks related to CMC activities.
• Regulatory Compliance: Ensure contracts comply with relevant industry regulations, laws, and internal corporate policies.
• Cross-Functional Collaboration: Act as a liaison between internal teams (e.g., legal, manufacturing, regulatory affairs) and external partners to gather information and resolve issues.
• Documentation & Records: Maintain an organized system of physical and digital records for all contract-related documents.
• Strategic Guidance: Provide expert advice to business teams on strategic objectives related to contract management within the Technical Operations and Quality areas.

Professional Experience/Qualifications

• Hands-on management of contracts supporting technical operations and quality systems
• Proven track record of successfully contract negotiation, writing, and maintaining a cohesive contracting strategy across similar partners
• Experience with longer term strategic planning, advancing effectiveness initiatives, and change management.
• Effective written and oral communication skills.
• A can-do attitude to join a dynamic, team-based, newly commercial biotechnology company

Education

• Law degree with some expertise in chemistry, biochemistry related area with 10+ years of relevant experience. Previous Biologics CDMO outsourcing contracting experience a definite plus.

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.