Director, Clinical Operations Study Lead

Key Responsibilities

• Provides strategic and operational leadership for one or more complex clinical studies, ensuring successful delivery through the study lifecycle (planning to execution)
• Ensures adherence to timelines, budgets, and quality standards
• Translates program strategy into executable study plans and milestones
• Develops and maintains clinical study timelines
• Utilizes operational data and metrics to drive high-quality planning processes and operational execution
• Maintains a comprehensive overview of study status, proactively communicating progress, risks, and mitigation strategies to stakeholders
• Leads/partners in the development and/or QC review of key study documentation (e.g., study protocols, informed consents, monitoring plans, operational manuals)
• Drives operational initiatives key to successful study execution including but not limited to site identification/qualification, site activation strategy, site performance management, overall enrollment success (including mitigation/rescue actions as needed)
• Represents Clinical Operations on Development and/or Program Team (under supervision of Clinical Operations Sr Management)
• Supports the Clin Ops Sr. Management in the development of timelines and aspects of strategic operational planning at the program level (eg scenario development)

Compliance & Process Improvement

• Ensures clinical activities are conducted in accordance with ICH-GCP, FDA, EMA, and other applicable regulatory guidelines and internal quality standards
• Supports or leads aspects of audit and inspection readiness and risk mitigation initiatives, including root cause analysis and CAPA development/closure for operational findings on assigned studies
• Actively contributes to the advancement of department and organizational initiatives and processes

Team Leadership & Development

• Leads study and/or project team(s), including effectively partnering with colleagues from other disciplines (Clinical Development, Regulatory, Data Management, Safety, Quality) and external partners (CROs, vendors, academic collaborators, alliance partners) to ensure seamless trial execution
• May provide line management, coaching, and mentorship to clinical operations staff

Innovation

• Contributes to the development and implementation of novel clinical operations activities and methods in cell therapy

Minimum Requirements

• Bachelor’s degree in life sciences or related field
• 10+ years’ experience in clinical operations within the pharmaceutical, biotech and/or CRO setting including at least 4 years in a study or team leadership role in a pharma or biotech company
• Experience supporting early and late stage clinical studies
• Preference for experience with BLA-enabling trials
• Experience in conducting pediatric studies a plus
• Excellent knowledge of clinical trial design, operational systems (CTMS, eTMF, EDC), and regulatory requirements (ICH-GCP, FDA, EMA)
• Strong vendor management skills and experience with complex outsourcing and partnership models
• Proven financial acumen
• Experience building and maintaining study budgets
• Exceptional verbal and written communication and stakeholder management skills
• Track record of developing and delivering high quality materials and updates for leadership forums
• Demonstrated ability to effectively collaborate with internal and external stakeholders in a highly matrixed setting
• Ability to thrive in a fast-paced, matrixed, and innovative environment

Estimated Compensation Range

The estimated compensation range for this position is $ 202,000.00 - $ 214,020.00 per year.

Equal Opportunity Workplace

At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.