Associate General Counsel - Clinical & Commercial - CRO Services at United-Biosource-Corporation

Job description

As a pharmaceutical support industry leader , UBC is devoted to empowering health solutions for a better tomorrow . We take pride in improving patient outcomes and advancing healthcare . At UBC we provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation. Embark on a rewarding career journey with UBC! Grow your career while making a meaningful impact on the world around you . UBC fosters a culture built on our Core Values being: Collaborative, Conscientious, Curious, Consultative, and Compassionate . We believe in an inclusive workplace that fosters creativity . If you are seeking a career that will challenge, inspire, and reward you , join us at UBC! Brief Description : The Associate General Counsel will provide (a) primary strategic legal counsel on clinical and commercial ( i.e ., patient access and support, and copay, programs) and healthcare regulatory matters, including US and EU clinical trials, and (b) provide support to UBC’s Data Privacy and other Legal team members with regard to privacy and data protection, both with a focus on supporting regulated biopharmaceutical, clinical research, and commercial healthcare services, and operations. This role will also advise cross-functional business, compliance, clinical and commercial operations, EU (and as necessary, US) human resources and employee relations, information security, quality, and other UBC stakeholders and teams on complex legal and regulatory issues. 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 (sufficient to support Privacy and Legal team functions and, as needed be a primary source of counsel in advising business-side stakeholders), 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. 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. Specific job duties: • 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, including informed consent language, authorization/enrolment form language, subject recruitment materials, investigator/site communications and agreements, trial data use, and cross-border data transfer considerations. • 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, 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, appropriately 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. Required Qualifications and Skills/Core Competencies: 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. Skills/Core Competencies – • 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. 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) UBC Benefits: At UBC, employee growth and well-being are always at the forefront. We offer an extensive range of benefits to ensure that you have everything you need to thrive personally and professionally. Here are some of the exciting perks UBC offers: • 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 UBC is proud to be 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. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients. #LI-RL1 #LI-REMOTE

Requirements

Must-haves

If you are seeking a career that will challenge, inspire, and reward you , join us at UBC!
Develop, update, and operationalize privacy policies, procedures, templates, playbooks, training materials, and governance processes tailored to healthcare and clinical research 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.
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, appropriately 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.
None initially, but subject to change based on evolution of role and candidate’s growth trajectory.
Required Qualifications and Skills/Core Competencies:
Qualifications –
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 supporting privacy leadership in a privacy program implementation, including management of DPIAs and DSARs.
Skills/Core Competencies –
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.
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.
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)
Remote opportunities
Competitive salaries
Growth opportunities for promotion
Tuition reimbursement (after 90 days of employment)

Nice-to-haves

None flagged.

Application prep

Use the role’s language and application details while tailoring your materials.

Keywords to mirror

machine learning

Platform: adp-workforce-now
Effort: medium

Benefits

Benefits detected in the listing.

Dental

Vision

401k

Pto

Paid Time Off

Wellness