Full-Time Executive Director, Assistant General Counsel, R&D

We are seeking a highly skilled and experienced Executive Director, Assistant General Counsel, R&D with a strong background in biotechnology.

Responsibilities:

• Develop and provide strategic counsel to leaders on legal and regulatory issues impacting product development, scientific communications, and product manufacturing.
• Proactively identify complex legal issues, develop creative solutions, and collaborate on implementation.
• Identify unmet needs and future legal issues, proposing strategies for optimal outcomes.
• Lead projects, including cross-functional teams, from inception to implementation; provide hands-on support including drafting, reviewing, and negotiating contracts.
• Partner across the business to achieve compliance with laws and regulations (intellectual property, data privacy, GxP, etc.).
• Develop deep knowledge of the company's business for thoughtful, creative, and business-minded legal advice.
• Act as a proactive business partner, build trusted advisor relationships, influence, and collaborate across all levels.
• Conduct legal research, staying updated on changes impacting R&D.
• Assist in negotiation and management of partnerships, collaborations, and licensing agreements.
• Provide training and guidance to internal teams on legal matters related to research and development, manufacturing, and quality.
• Mentor legal staff and collaborate with external counsel.
• Perform additional duties as assigned.

Qualifications:

• JD from an accredited law school and current bar admission in at least one U.S. state
• 15+ years of relevant experience (law firm or in-house pharmaceutical company)
• Strong knowledge and understanding of pharmaceutical laws and regulations
• Ability to adapt to a changing environment and handle multiple priorities
• Sound judgment and ability to support decision-making
• Familiarity with clinical trial agreements, material transfer agreements, and other R&D contracts
• Knowledge of FDA regulations and guidelines
• Excellent analytical, problem-solving, and communication skills
• Ability to work independently and as part of a team
• Strong attention to detail and organizational skills
• Strong personal integrity and global mindset
• Ability to manage heavy workload, prioritize, and work under pressure
• (Plus) International regulatory processes, clinical trials, assay development, advising manufacturing.

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