Legal Counsel, Research & Development

Role Summary

We are seeking a highly collaborative and enthusiastic attorney to join our team as Legal Counsel, Research and Development. Reporting to the VP, R&D and Contracts, you will blend deep contracting experience with strategic legal support for our research and development functions focused on gene therapy approaches to treat diseases. You will be responsible for a wide range of contracts, including clinical trial, research, manufacturing, material transfer, service, consulting, statements of work and other strategic agreements. As an integral part of the legal team, you will play a key role in partnering with teams across the organization, particularly our clinical operations team and internal stakeholders who lead uniQure’s ongoing research and development programs. You will also work cross-functionally to identify legal risks and provide sound counsel and advice to mitigate such risks, while conveying them in business-first terms to the business. Additionally, you will support the routine contracting needs for the US Human Resources, IT, Facilities, and Commercial functions.

The ideal candidate is a proactive, detail-oriented, strategic problem solver who values collaboration and intellectual curiosity. This involves close collaboration with internal business teams to ensure an understanding of their needs while fostering a trusted partnership around legal matters, as well as building strong relationships with legal colleagues. Additionally, this role will support a growing contracts and legal operations function with a variety of operational goals around templates, playbooks, and establishing and improving processes and procedures for both the legal team and the business.

This role is best suited for a versatile and hands-on attorney with 6+ years of legal experience in pharmaceutical research and development and clinical trials who is looking for a role with meaningful opportunities for professional development. Law firm and in-house experience at an early-stage pharmaceutical/biotech company is preferred.

Responsibilities

• Draft, review, and negotiate a wide variety of R&D related contracts including CDAs, services agreements, clinical trial agreements, quality agreements, supply agreements, manufacturing agreements, material transfer agreements, vendor agreements, and consulting agreements. Preference will be given to candidates who have experience with global clinical trials and associated regulatory requirements.
• Provide business partnership to the clinical operations, research and development, quality, regulatory, and manufacturing teams, as a legal subject matter expert on contract interpretation and related legal best practices.
• Assess contracts to determine operational and legal obligations and potential risks and advise internal stakeholders in a timely, pragmatic and logical way.
• Cultivate strong and highly effective cross-functional relationships and communication with internal colleagues to effectively address legal and business questions.
• Partner effectively with the broader Legal and Compliance teams by building a positive culture, sharing best practices, and contributing to efforts to create, improve, and operationalize internal processes, contract templates, and tools.
• Stay current with applicable laws, regulations, trends and industry-specific guidance impacting drug development and more generally, healthcare; ensure the company maintains compliance with evolving global regulations.
• Assist members of the legal department with other legal needs of the company as needed.
• Appropriately triage a heavy workflow, setting appropriate priorities with internal clients and delivering results efficiently.
• Maintain and update contract templates aligned with industry standards and legal requirements globally.
• Support contract compliance efforts, including ensuring the use of approved templates, identifying deviations from standard terms, and escalating issues appropriately.
• Partner with Legal Operations to continually improve the contracting process to ensure efficiency and provide internal education on legal policies and procedures.

Qualifications & Skills

• Juris Doctor degree with excellent academic credentials; active membership in good standing with the Massachusetts Bar or another U.S. bar.
• At least 6+ years of relevant legal experience in the biotechnology or pharmaceutical industry, ideally gained at a respected law firm followed by in-house roles; experience in both law firm and industry settings required.
• Extensive knowledge of relevant laws, regulations, and industry codes, with particular knowledge of the legal and regulatory environment for biotech/pharma, human subject protection regulations, data rights and privacy and Good Clinical Practice standards.
• Deep experience in complex contract drafting and negotiation, especially for drug research/development, corporate, and commercial functions; demonstrated success managing CTAs, CROs, MSAs, vendor agreements, and high-volume contract portfolios with sound judgment and a practical, risk-aware approach. Experience with HCP interactions, clinical trial protocols, ICFs, and/or commercial agreements is a plus.
• Strong technical, analytical, and problem-solving skills, with a track record of developing creative solutions and delivering high-impact results independently and proactively.
• Excellent oral and written communication skills, with a flair for presenting complex information, influencing stakeholders, and facilitating cross-functional collaboration.
• Independent, courageous leader for effective cross-functional collaboration.
• Sound judgment, issue spotting, and decision-making skills.
• Flexible and adaptable to shifting deadlines and priorities; works well under pressure and can manage multiple tasks in fast-paced, deadline-driven environments.
• Strong interpersonal, collaborative, and organizational savvy; approachable team player able to build relationships across different teams and other business functions, treating all colleagues as valued internal clients and addressing differences equitably.
• Demonstrates unquestionable ethics, integrity, responsibility, and high professional standards; acts conscientiously and maintains a collegial attitude with a healthy sense of humor.
• Self-motivated quick learner; able to set and manage personal and team priorities and adapt to changing business needs.
• Advanced computer and document management skills (including Agiloft and redlining software).

Location

This role may be remote or hybrid with part-time, on-site in Lexington, MA. Some travel to other uniQure sites may be required.