Associate General Counsel – CRO Services

Role Overview

The Associate General Counsel will provide primary strategic legal counsel on clinical and commercial matters, including US and EU clinical trials, and healthcare regulatory matters. The role requires comfort operating in a highly regulated and dynamic environment and partnering closely with business stakeholders to manage legal risk while enabling responsible innovation, compliant clinical research activities, and legally sound workforce decisions.

What You Will Do

Serve as a primary/lead legal adviser with respect to the Company’s clinical and commercial biopharma services operations, regulatory, pharmacovigilance, real-world evidence, data management, and business teams on legal and regulatory issues arising in clinical and commercial CRO/biopharma services programs. Provide legal support for clinical trial and commercial program regulatory documentation and operational processes.

Why It Might Be a Fit

The successful candidate will bring broad and deep clinical trial and commercial regulatory knowledge and sound judgment, a firm understanding and experience with privacy and data protection, and practical knowledge of EU employment law, including multi-jurisdictional employee relations, workforce transitions, employee privacy, works council or employee representative engagement, and employment-related data protection issues.

Requirements

• Minimum of 15 years legal experience, including at least 7 years in-house legal experience at increasingly more responsible levels, in a clinical research organization, biopharma services, or pharmaceutical/biotechnology company.
• Experience advising on global clinical trials, decentralized or hybrid trial models, real-world evidence, registries, patient access/support programs, pharmacovigilance.
• Familiarity with global privacy laws and regulations.
• Experience with artificial intelligence, machine learning, data analytics, de-identification, anonymization, pseudonymization, cybersecurity, and data governance frameworks in a life sciences setting.
• Experience advising on EU workforce matters, including multi-country employee relations, restructuring or redundancy processes, works council or employee representative engagement, workplace investigations, and employment litigation or dispute strategy.
• Strategic legal judgment and savvy risk assessment: Ability to assess complex clinical and commercial regulatory risks, as well as privacy considerations, and provide prudent, clear, actionable recommendations.

Benefits

• Remote opportunities
• Competitive salaries
• Growth opportunities for promotion
• 401K with company match
• Tuition reimbursement (after 90 days of employment)
• Flexible work environment
• Discretionary PTO (Paid Time Off)
• Paid Holidays
• Employee assistance programs
• Medical, Dental, and vision coverage
• HSA/FSA
• Telemedicine (Virtual doctor appointments)
• Wellness program
• Adoption assistance
• Short-term disability (after 90 days of employment)
• Long-term disability
• Life insurance
• Discount programs