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Legal Counsel for Clinical Research

2 months ago

Chicago, Illinois, United States AbbVie Full time
Position Overview

At AbbVie, we are dedicated to pioneering innovative therapies that address significant health challenges. Our commitment spans various therapeutic domains, including immunology, oncology, neuroscience, and eye care, as well as our offerings in the Allergan Aesthetics sector. For more insights about our mission and values, please explore our corporate website.

Role Summary

The Legal Counsel for Clinical Research will play a vital role in facilitating clinical investigations aimed at developing groundbreaking treatments that significantly benefit patients. This position is essential within a collaborative team of legal professionals providing strategic guidance and support to AbbVie's Global Research and Development (R&D) division. Candidates who exhibit strong leadership capabilities and strategic insight will find this role offers the chance to engage with cross-functional teams, including those in intellectual property, litigation, global privacy, and compliance.

Key Responsibilities

The Legal Counsel for Clinical Research will:

  • Advise the Clinical Development Organization on legal matters throughout the research process, from initial concept and trial design to all phases of clinical development, while considering the legal and regulatory implications of corporate decisions.
  • Effectively communicate legal advice on complex issues related to clinical research, including patient rights, data integrity, compliance, and digital health considerations.
  • Draft, review, and negotiate a diverse range of agreements, including clinical study agreements, collaborative research contracts, and service provider agreements essential for clinical trial operations.
  • Develop informed consent documents for clinical research, incorporating feedback from regulatory bodies and ethics committees.
  • Provide strategic legal counsel to clients, ensuring that legal advice aligns with the potential of our pharmaceutical pipeline.
  • Serve as a recognized expert in intricate legal, business, technology, or research areas, offering innovative solutions to management and colleagues.
Qualifications
  • J.D. degree with active state licensure.
  • Experience in providing legal counsel on R&D matters, particularly clinical trials.
  • Ability to align legal guidance with pharmaceutical business objectives, effectively managing risk.
  • Proficient in transactional drafting and legal analysis, with strong communication skills to address critical issues promptly.
  • Capability to collaborate effectively with internal stakeholders and cross-functional teams.
  • A minimum of five years of relevant legal experience, with preference for in-house experience.
  • Prior knowledge of FDA regulations and guidance is advantageous.
  • This position offers a hybrid work model, requiring a portion of time to be spent onsite.
Additional Information

AbbVie is committed to fostering a diverse and inclusive workplace. We value the unique contributions of every individual and strive to create an environment where all employees can thrive. We encourage qualified candidates from all backgrounds to apply.