Legal Counsel

Responsibilities

• Provide leadership and management for clinical trial contracting processes, day-to-day advice and review of contracts with Clinical Research Organizations (CROs) and other clinical trial vendors and clinical trial sites, liaising with senior leaders to manage and escalate issues and working cross-functionally and within the Legal & Compliance Department to ensure streamlined clinical trial contracts review and consistency in compliance with applicable policies and process for the Contract Lifecycle Management platform (CLM).
• Draft, review, and negotiate confidentiality agreements, research and development agreements, clinical trial agreements, master service agreements, statements of work, informed consent forms, material transfer agreements, license agreements, vendor agreements, service agreements, and other clinical trial agreements and documentation.
• Provide leadership and management for the Company’s CLM with respect to clinical agreements with assistance from other members of the Legal Compliance team, with a focus on developing playbooks, templates and standard terms and conditions and processes for clinical trial agreements and documentation, including incorporating the use of AI tools to improve efficiencies and effectiveness in the contracting process.
• Advise business leaders on strategies and tactics in a way that advances the company's business objectives while addressing legal risks and protecting the company's integrity and reputation.
• Proactively identify legal and compliance risks and work with other internal stakeholders to effectively eliminate or mitigate those risks while concurrently supporting business strategic goals.
• Advises on other legal matters that arise across various functions within the company.
• Manage outside counsel as needed in connection with executing above responsibilities and duties.
• Contribute to other projects and areas, which may include research and development, clinical trials, manufacturing or commercial and medical matters, as determined in consultation with other members of the Legal Compliance team.

Qualifications And Skills

• Law degree from an ABA law school and current admission to the bar.
• Typically requires 5-8 years of experience in a large law firm, biotech/pharma company, or government agency practicing law and supporting clinical trials, or the equivalent combination of education and experience.
• Broad understanding of the life sciences industry and the types of contracts and issues that arise within clinical operations, including a familiarity with FDA rules and regulations related to clinical trials and development of pharmaceutical products.
• Substantial experience drafting, negotiating and processing clinical trial contracts with CROs and clinical trial sites and investigators as well as experience or, in the absence of demonstrated experience, a willingness and aptitude for playing a leading role in the oversight of clinical contracting processes and the Company’s CLM.
• The ideal candidate will have demonstrated expertise advising on the legal, regulatory, and operational aspects of global clinical trials, including clinical trial agreements, CRO and investigator contracting, informed consent, data governance, and cross-border research activities.
• Strong knowledge of applicable global regulatory requirements and quality standards, including FDA and GCP requirements, is fundamental, with a preference for candidates with a solid understanding of the impact of global privacy and data protection laws on clinical operations.
• The ideal candidate will have demonstrated experience and the ability to provide practical, risk-based guidance to support compliant and efficient clinical development programs.
• Outstanding communication, with strong ability to communicate across various functions.
• Highly collaborative, with excellent judgment and interpersonal skills and the ability to work in a fast-paced, high-growth environment.
• Expert ability to constructively counsel and influence clients to take appropriate actions and make complex decisions.
• Capacity to simultaneously handle a variety of complex legal matters with minimal guidance.
• Demonstrable experience taking ownership of issues and providing timely, actionable advice.
• Exceptional written, organization, and presentation skills.

Pay

This role may be eligible for a salary range of $200,000 - $340,000, with actual pay determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may also be available based on individual and company performance.