Overview
This role serves as the organization’s senior legal advisor and strategic partner to the leadership team. The General Counsel will manage a broad portfolio of legal matters with a focus on commercial contracting, complex negotiations, intellectual property, litigation, regulatory compliance, and enterprise risk management in a fast-paced, highly regulated environment.
Responsibilities
- Serve as a trusted legal and strategic advisor to the leadership team and other senior business leaders on commercial, operational, regulatory, and corporate matters.
- Lead the drafting, review, and negotiation of complex commercial agreements, including customer, supplier, manufacturing, licensing, confidentiality, technology, consulting, and strategic partnership agreements.
- Develop practical contracting strategies and processes to improve speed, consistency, accountability, and business outcomes while maintaining appropriate legal protections.
- Advise on intellectual property strategy, protection, licensing, ownership, confidentiality, trade secrets, and related commercial considerations.
- Direct litigation, investigations, claims, and dispute-resolution matters, including the selection, management, and oversight of outside counsel.
- Identify and evaluate legal and regulatory risks and provide clear, actionable recommendations that balance risk mitigation with commercial and operational priorities.
- Ensure compliance with applicable federal, state, and local laws and regulations, including requirements applicable to pharmaceutical, radiopharmaceutical, pharmacy, manufacturing, and GMP-regulated operations.
- Partner closely with Quality, Regulatory, Compliance, Operations, Commercial, Human Resources, Finance, and other functions to support business initiatives and resolve issues efficiently.
- Provide legal support for corporate governance, strategic transactions, financing activities, mergers and acquisitions, and other enterprise initiatives, as applicable.
- Advise on employment, organizational, and workplace matters in partnership with Human Resources and external employment counsel, as appropriate.
- Establish and maintain effective legal policies, controls, templates, playbooks, and training programs that strengthen compliance and enable efficient decision-making.
- Monitor relevant legal and regulatory developments and proactively advise leadership regarding potential business impact and required actions.
- Manage the legal function, including its budget and the effective use of internal resources, outside counsel, and other legal service providers.
- Build and develop a high-performing legal team capable of supporting a growing, complex, and highly regulated business.
Requirements
- Juris Doctor degree from an accredited law school.
- Active membership in good standing with at least one U.S. state bar.
- Minimum of 15 years of progressive legal experience, including substantial in-house corporate experience and demonstrated responsibility for complex commercial and regulatory matters.
- Significant experience drafting and negotiating sophisticated commercial contracts and resolving complex business issues.
- Demonstrated experience managing intellectual property matters, litigation, investigations, and outside counsel.
- Strong understanding of corporate governance, employment law, regulatory compliance, and enterprise risk management.
- Proven ability to translate complex legal issues into concise, practical, and commercially relevant guidance.
- Sound judgment and the ability to distinguish between material enterprise risks and issues that can be addressed through pragmatic business solutions.
- Demonstrated ability to manage multiple priorities, make timely decisions, and deliver results in a high-growth, fast-paced environment.
- Strong executive presence and exceptional negotiation, drafting, communication, and relationship-management skills.
- High ethical standards, integrity, discretion, and accountability.
Preferred Qualifications
- Experience supporting pharmaceutical, radiopharmaceutical, biotechnology, CDMO, pharmacy, healthcare, or other highly regulated manufacturing operations.
- Working knowledge of GMP requirements and the federal, state, and local regulatory frameworks affecting regulated pharmaceutical and manufacturing businesses.
- Leadership experience managing legal professionals and external legal resources.
Equal Employment Opportunity
The organization is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by applicable law.
Location
Not specified.