Assistant General Counsel

2 months ago

Stevenage Hertfordshire, United Kingdom Spur Therapeutics Full time

Why Spur?

Gene therapy is at an inflection point. Amidst the noise of countless emerging modalities, we've been hard at work refining our science and advancing our programs with quiet determination and a bold ambition to unlock the true potential of gene therapy to change the trajectory of more patients' lives. Come join Spur's dedicated team of scientists, physicians and other professionals who are singularly focused on using cutting-edge science and technology to transform the treatment of serious and debilitating chronic diseases.

What We Are Trying to Accomplish

We are a clinical-stage biotech company developing transformative adeno-associated virus (AAV) vector-mediated gene therapies. Founded in 2015, Spur is focused on developing innovative, one-time treatments that set new standards of care. Our integrated gene therapy platform includes in-house capabilities in research, protein engineering and clinical development, and we optimize every component of our product candidates to develop first- and best-in-class gene therapies. We are currently advancing a highly differentiated gene therapy candidate in a Phase 1/2 clinical trial in people with Gaucher disease. We are working on additional programs in research, with a focus on CNS and cardiovascular diseases, to reach even more patients with our potentially life-changing treatments. Spur is global, with research facilities and offices in Stevenage, UK, and offices in Boston and New York.

How We Will Do It

We are relentless in our pursuit of transformative medicines for patients. We take innovation seriously and know we need to be bold both in our science and in every aspect of our work. We also know we can only achieve these things together, so we act as one Spur and expect that of each colleague in the company. We always do the right thing – the trust of patients and their caregivers is critical to our success. If you have an entrepreneurial mindset, are willing to work hard to transform the lives of patients, and share our values, then Spur could be the place for you.

Role Purpose

This is a hybrid role, located in Stevenage, UK.

We are seeking an Assistant General Counsel to join our legal team and own a wide variety of legal matters.

You will provide pragmatic legal counsel to all levels of the organization, with primary responsibility for supporting our innovative programs in pre-clinical and clinical development. You will be responsible for identifying and analyzing legal issues, drafting and reviewing key clinical, manufacturing, commercial and service contracts, presenting clear recommendations, and ensuring legal compliance.

Strong drafting skills are a must, and experience with a variety of life sciences research and development and commercial experience preferred. The position will involve regular collaboration with Spur's medical, research, clinical development and People teams and senior company management. This is a strategic and highly visible role within a growing organization, with opportunities for professional growth and development.

Responsibilities

  • Provide primary legal support for Spur's medical, regulatory and research activity with a focus on reviewing, negotiating and drafting various agreements.
  • Review investigator brochures, informed consent forms and clinical trial protocols relating to Spur's current and future Phase 1/2 and Phase 3 trials.
  • Review and negotiate master services agreements, statements of work, material transfer agreements, service level agreement terms, employment and consulting agreements, nondisclosure agreements, vendor agreements and related biotechnology services contracts.
  • Provide primary legal support to evolving company activities including commercial, business development and human resources activities.
  • Be a company resource for contract-related questions and processes.
  • Advise management on compliance with a wide range of legal and regulatory matters.
  • Work cross-functionally with various departments to meet business objectives.
  • Develop and maintain updated template agreements that reflect Spur's research, clinical development, medical affairs and human resources objectives.
  • Provide subject matter expertise, and legal support and guidance on the development and application of standard operating procedures (SOPs) and related documents.
  • Lead the effort to establish a contracts management system and request process to streamline contract operations.

Qualifications & Experience Required

  • Qualified UK lawyer with adequate years post-qualification experience.
  • In-house and/or private practice experience in the pharmaceutical/life sciences sector.
  • Experience with general business contracting and clinical trial agreements.
  • Experience in a clinical-stage biotechnology company or research-based institution preferred; prior experience in gene therapy a plus.
  • Pragmatic thinker and problem solver with the confidence, discretion and ability to advise the Executive Leadership Team.
  • Ability to negotiate independently with scientific, medical and business partners on matters of strategic importance that affect a substantial portion of the business or matters of significant importance to senior management.
  • Excellent contract drafting and negotiating skills, with an eye for detail combined with pragmatism and sound judgment.
  • A clear, collaborative communicator with a strong attention to detail, organizational prowess and excellent judgment.
  • Ability to work at pace and with quality.
  • Comfortable with prioritizing work appropriately and managing multiple projects in parallel.
  • An eager, flexible learner who's confident handling tasks and answering questions they've never faced previously.
  • Experience with international privacy laws (e.g., GDPR) and interconnection with clinical trial activities and data.

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