Boulevard Bio
Lead the strategic and operational execution of clinical programs, overseeing clinical trial planning, execution, and monitoring while ensuring adherence to timelines, budgets, and quality standards. Collaborate with cross-functional teams and external partners to optimize clinical trial protocols, site management, regulatory compliance, data management, and patient safety.
Key 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
Required
- • 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
- • 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
- • Previous experience in a senior-level clinical operations role or equivalent leadership position is preferred
Benefits & Perks
- • Competitive compensation package
- • Comprehensive benefits including company sponsored medical, dental, and vision coverage
- • Meaningful equity opportunities
Overview
About 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. Our pipeline is led by a highly differentiated BAFF/APRIL dual inhibitor, designed for subcutaneous administration on a Q12W+ schedule. This lead candidate offers an accelerated clinical path toward establishing a new disease-modifying standard of care in IgA Nephropathy (IgAN). Beyond our lead asset, our pipeline includes two additional programs focused on B cell reset and combination of B cell biology and other drivers of disease.
Founded and backed by Deerfield Management, Boulevard Bio is led by a team of industry veterans with a proven track record of advancing molecules from preclinical discovery through clinical development and successful commercialization as well as fund-raising. With a strong foundation and a clear strategic vision, Boulevard aims to create significant value creation and clinical impact in the near term.
We are seeking an experienced and visionary Vice President of Clinical Operations to lead the strategic and operational execution of our clinical programs. This role is ideal for a dynamic leader who thrives in a fast-paced, entrepreneurial environment and can effectively bridge strategic planning with day-to-day operational excellence.
Key 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
Qualifications and Requirements:
- 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
- Previous experience in a senior-level clinical operations role or equivalent leadership position is preferred
Why Boulevard Bio:
Culture, Impact, and Accelerated Growth: As an early clinical-stage company, your contributions will be vital and impactful. You will have the opportunity to work closely with industry veterans, contribute to a range of projects across various stages of the clinical development lifecycle, and build a breadth of experience while working in an organization that values people.
Stability and Vision: Backed by Deerfield Management, we combine the agility of a startup with the strategic resources of a longstanding healthcare investment firm.
Total Rewards: We believe in sharing our success with the people who build it. We offer a competitive compensation package, comprehensive benefits including company sponsored medical, dental, and vision coverage, and meaningful equity opportunities that allow you to have a stake in the value you create.
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