Senior Legal Counsel, Development

4 weeks ago


Oklahoma City, United States CareerBuilder Full time

Location: Lexington, 1 Hartwell Pl Education level: Bachelor / Graduate

Job category: Legal & Intellectual Property Target start date: 4/1/2024

Work Location: Hybrid Shift: 1st

We are looking for a collegial, practical legal advisor with a deep understanding of the laws relating to pharmaceutical drug development and commercialization to join the uniQure Legal team. The ideal candidate is someone who thrives in a fast-paced environment, is a strategic problem solver, and who is proactive, flexible, detail-oriented, and hands-on. The Development Counsel will report to the Vice-President Legal, Development and Compliance, and will partner with stakeholders throughout the global organization to advance uniQures ongoing development programs, which are currently focused in the areas of Huntingtons Disease, Temporal Lobe Epilepsy, ALS and Fabry Disease. In addition, the Development counsel will provide support for the Companys discovery activities and will play an integral role in the evolution of the Companys compliance efforts and privacy program. This is a role with a clear immediate focus, the opportunity to solve complex and challenging issues, and to be part of a team that works collaboratively to contribute meaningfully to our business.

Location :

This role is located in Lexington, MA and requires weekly in office time two or three days per week. Some travel to other uniQure sites may be required.

Responsibilities

Key result areas (major duties, accountabilities and responsibilities)

Independently draft and negotiate a wide variety of R&D related contracts including, but not limited to, CDAs, services agreements, clinical trial agreements, collaboration agreements, supply chain agreements, and consulting agreements. Preference will be given to candidates who have experience with global clinical trials and associated regulatory requirements.
Provide risk mitigation, legal advice, and corporate compliance guidance to the clinical operations, quality and regulatory teams.
Support companys interactions with not for profit groups, academic research centers, etc. by drafting and negotiating agreements covering specific research projects.
Partner with others within the legal team to ensure adherence to US and global data protection and data privacy laws; working knowledge of, or willingness to learn, data privacy and security laws, including GDPR, CCPA and HIPAA
Foster a culture of compliance in uniQures interactions with healthcare professionals and patient advocacy organizations.
Advise on contractual obligations with existing partners
Contribute to the Legal teams efforts to create, improve, and operationalize internal processes, contract templates and tools.
Stay current with applicable foreign and domestic federal, state, and local laws impacting drug development and more generally, healthcare; ensure the company maintains compliance with evolving global regulations
Engage as a member of cross-functional teams to ensure that grants and other funding are compliant and aligned with corporate goals
Communicate legal advice to business stakeholders in an pragmatic and logical way
Assist members of the legal department with other legal needs of the company as necessary
Appropriately triage a heavy workflow, setting appropriate priorities with internal clients and delivering results efficiently
Ensure internal clients receive sound, practical and timely legal advice and support
Foster strong working relationships with internal clients, while balancing legal risks
At least 10+ years of relevant legal experience in Life Sciences.
Licensed to practice law in one or more US jurisdictions.
Excellent oral and written communications skills.
Unquestionable ethics, integrity, and judgment.
Demonstrated courageous leadership and organizational savvy necessary to collaborate effectively with cross-functional teams.
Team player and strong collaboration skills and a willingness to be proactive and flexible.
A solid understanding of the biotech/pharmaceutical and/or medical device/IVD industry, including product development, commercialization, and the legal and regulatory environment. Working knowledge of human subject protection regulations, and international standards for Good Clinical Practices.
Solutions oriented with demonstrated record of problem-solving.
Strong ability to influence and present complex information to colleagues and tackle challenging issues beyond the core competencies.
Demonstrated success in proactively and independently driving for and delivering results with high impact.
A team player who likes to learn and teach, and can self-manage priorities, time, and projects.

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