Overview
This position is offered fully home based (remote).
The Associate General Counsel will provide strategic legal counsel on clinical and commercial (including patient access and support, and copay programs) and healthcare regulatory matters, including US and EU clinical trials. This role also supports Data Privacy and other Legal team members regarding privacy and data protection, with a focus on regulated biopharmaceutical, clinical research, and commercial healthcare services and operations.
The position advises cross-functional business, compliance, clinical and commercial operations, EU (and as necessary, US) human resources and employee relations, information security, quality, and other stakeholders on complex legal and regulatory issues.
Responsibilities
- Serve as a primary/lead legal adviser for 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, including:
- informed consent language
- authorization/enrolment form language
- subject recruitment materials
- investigator/site communications and agreements
- trial data use
- cross-border data transfer considerations
- Support Privacy and Legal teammates by advising business stakeholders on compliance with privacy and data protection frameworks, including GDPR, UK GDPR, HIPAA state consumer privacy laws, health data privacy requirements, breach notification laws, and other applicable federal, state, and international requirements.
- Monitor legal and regulatory developments affecting clinical research, privacy, cybersecurity, data governance, health data, artificial intelligence, and emerging technologies; assess business impact and recommend practical compliance strategies.
- Develop, update, and operationalize privacy policies, procedures, templates, playbooks, training materials, and governance processes tailored to healthcare and clinical research activities.
- 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.
- Support privacy-by-design and compliance-by-design reviews for new programs, systems, technologies, data initiatives, artificial intelligence tools, digital health solutions, and vendor engagements.
- 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, works council or employee representative matters, collective consultation processes, and employee privacy considerations.
- Provide practical legal guidance on EU and multi-jurisdictional employment law matters, including hiring, employment documentation, workplace policies, employee relations, disciplinary actions, terminations, redundancies, restructurings, consultation obligations, employee transfers, and employment-related disputes.
- 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.
- Serve as a trusted advisor to senior leadership and business clients by balancing legal risk, patient protection, operational feasibility, and business objectives.
- Coordinate with outside counsel and internal stakeholders on complex regulatory, contractual, transactional, and compliance matters.
Supervisory Responsibility
None initially, but subject to change based on evolution of role and candidate’s growth trajectory.
Qualifications
Required Qualifications and Skills/Core Competencies
- 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.
Skills/Core Competencies:
- Strategic legal judgment and savvy risk assessment: assess complex clinical and commercial regulatory risks and 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; 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: guide cross-functional stakeholders, manage competing priorities, and drive alignment across legal, compliance, privacy, technology, clinical, and commercial teams.
- Pragmatism and accountability: ownership mindset, sound risk tolerance, and ability to deliver practical advice under tight timelines.
Reporting Relationship
The position will report to, and support, the SVP/Chief Legal Officer, and support (but not report to) the Data Protection Officer (who reports to SVP/Chief Legal Officer).
Compensation & Benefits
Benefits include:
- 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
Location
Fully home based (remote).
Equal Opportunity
The employer is an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state, or local protected class. A diverse, equitable and inclusive culture is promoted, with respect for each other, clients, and patients.