Associate General Counsel - CRO Services

About the role

The Associate General Counsel will provide strategic legal counsel on clinical and commercial matters, including US and EU clinical trials, and support the Privacy and Legal team with privacy and data protection.

Responsibilities

• Provide legal support for clinical trial and commercial program regulatory documentation and operational processes.
• Support Privacy and Legal teammates with respect to, and serve as a primary resource in, advising business stakeholders on, compliance with privacy and data protection frameworks.
• Lead or advise on privacy impact assessments, data protection impact assessments, legitimate interest assessments, data mapping, records of processing activities, and risk analyses for clinical and healthcare data processing activities.
• Partner with Human Resources, Employee Relations, Compliance, and business leaders on workforce initiatives in Europe, including coordination with local counsel on country-specific employment law requirements.
• Draft, review, mark-up and negotiate client and vendor master and independent contractor master/service agreements, work orders and change orders, data processing agreements and data sharing agreements.
• Coordinate with outside counsel and internal stakeholders on complex regulatory, contractual, transactional, and compliance matters.

Requirements

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, practical knowledge of EU employment law, and comfort operating in a highly regulated and dynamic environment.

Qualifications

• 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.
• Experience supporting privacy leadership in a privacy program implementation, including management of DPIAs and DSARs.
• 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.
• Business partnership with time sensitive/solutions orientation: Collaborative approach to supporting operational teams while maintaining appropriate legal and compliance safeguards; commitment and focus on prompt/timely assessment and solutions-delivery.
• Regulatory fluency: Strong understanding of the intersection of privacy, healthcare, clinical trial, EU employment law, employee data protection, data governance, and technology requirements.
• Contracting expertise: Ability to draft, negotiate, and operationalize sophisticated commercial contracts, and privacy, data protection, clinical research, and vendor terms.
• Leadership and influence: Ability to guide cross-functional stakeholders, manage competing priorities, and drive alignment across legal, compliance, privacy, technology, clinical, and commercial teams.
• Pragmatism and accountability: Strong ownership mindset, sound risk tolerance, and ability to deliver practical advice under tight timelines.

Skills

• Broad and deep clinical trial and commercial regulatory knowledge.
• Sound judgment and practical experience with privacy and data protection.
• Comfort operating in a highly regulated and dynamic environment.
• Experience with artificial intelligence, machine learning, data analytics, de-identification, anonymization, pseudonymization, cybersecurity, and data governance frameworks.
• 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.
• Experience supporting privacy leadership in a privacy program implementation, including management of DPIAs and DSARs.
• Strategic legal judgment and savvy risk assessment.
• Business partnership with time sensitive/solutions orientation.
• Regulatory fluency.
• Contracting expertise.
• Leadership and influence.
• Pragmatism and accountability.

Benefits

At UBC, we offer remote opportunities, competitive salaries, growth opportunities for promotion, a 401K with company match, tuition reimbursement (after 90 days of employment), flexible work environment, discretionary PTO (Paid Time Off), paid holidays, 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, and employee assistance programs.