Boulevard Bio · 1 day ago
Vice President of Clinical Operations
Boston, MA
Full-time
Onsite
Director/Executive
10+ years expBoulevard Bio is a private, clinical-stage biotechnology company focused on developing innovative medicines for autoimmune diseases. They are seeking a Vice President of Clinical Operations to lead the strategic and operational execution of their clinical programs, ensuring adherence to timelines and quality standards while fostering a culture of excellence within the clinical operations team.
Biotechnology
Responsibilities
Develop and implement the clinical operations strategy, aligning it with the company's overall goals and vision
Provide leadership and direction to the clinical operations team, fostering a culture of excellence and collaboration
Oversee the planning, execution, and monitoring of all clinical trials, ensuring adherence to timelines, budgets, and quality standards
Collaborate with cross-functional teams, including Research and Development, Technical Operations, Regulatory Affairs, to design and optimize clinical trial protocols
Identify and evaluate potential clinical trial sites, establishing strong relationships with investigative sites and principal investigators
Ensure effective site management and support to facilitate smooth recruitment and execution of clinical trials
Ensure compliance with all relevant regulatory requirements and guidelines governing clinical trials
Work closely with regulatory affairs teams to prepare and submit necessary documentation for regulatory approvals
Oversee the collection, management, and analysis of clinical trial data, ensuring accuracy and completeness
Collaborate with internal and external biostatisticians and data management teams to generate insights and interpret clinical trial results
Prioritize patient safety and ethical considerations throughout all clinical operations, adhering to Good Clinical Practice (GCP) guidelines
Implement appropriate safety monitoring and reporting procedures for clinical trials
Collaborate with external vendors and Contract Research Organizations (CROs) to outsource certain clinical trial activities as needed
Manage vendor relationships and ensure deliverables meet quality and timeline expectations
Develop and manage the clinical operations budget, optimizing resource allocation for maximum efficiency and productivity
Ensure effective utilization of resources to achieve clinical objectives
Foster strong communication and collaboration with other departments to align clinical operations with overall company strategies
Stay informed about advancements in clinical trial methodologies and relevant research to propose innovative approaches for clinical operations
Implement process improvements to enhance the efficiency and quality of clinical trial execution
Qualification
Required
Advanced degree in a relevant scientific field (e.g., MD, PhD, MS, or equivalent) preferred
Early-stage experience will be key as the selected individual will be setting the direction for the organization on the lead and subsequent clinical programs
Extensive experience (10+ years) in clinical operations management within the pharmaceutical or biotechnology
Proven track record of successful leadership and management of clinical trials and teams
Strong understanding of clinical trial regulations and guidelines
Excellent communication, negotiation, and problem-solving skills
Preferred
Previous experience in a senior-level clinical operations role or equivalent leadership position is preferred
Benefits
Company sponsored medical, dental, and vision coverage
Meaningful equity opportunities
Company
Boulevard Bio
Boulevard Bio is a private, clinical-stage biotechnology company dedicated to developing best-in-class medicines to address B cell driven autoimmune diseases of significant clinical and commercial unmet need to transform patient’s lives.
2-10 employeesFunding
Current Stage
Early StageCompany data provided by crunchbase