Vice President, Clinical Operations

iBio•San Diego, CA

2d•$267,417 - $354,483•Onsite

About The Position

iBio is an AI-driven innovator developing therapies for cardiometabolic, obesity, and cardiopulmonary diseases. The Vice President, Clinical Operations is a strategic leader responsible for shaping and scaling the Clinical Operations function and advancing the company’s clinical development pipeline. The role works closely with the Chief Medical Officer and cross-functional leaders to translate clinical development strategy into effective execution and build capabilities to support company growth. The position is onsite in Sorrento Valley, San Diego, California. The Vice President provides overall leadership and accountability for Clinical Operations, clinical development programs and trial execution, organizational development, quality systems, external partnerships, budgets, resources, governance, and operational performance. The role leads and develops the Clinical Operations organization, establishes scalable processes and capabilities, and serves as a strategic advisor to executive leadership. The position also monitors industry practices, regulatory expectations, technologies, and trends to identify opportunities to strengthen clinical development capabilities. The expected annual base salary is $267,417 to $354,483, plus bonus, equity, and comprehensive benefits. A discretionary annual bonus may be available based on individual and Company performance. Individual pay is determined by factors including qualifications, relevant experience, skills, education, work location, and organizational needs.

Requirements

Bachelor’s degree with at least 15 years of progressive experience, or a master’s degree with at least 13 years of progressive experience, in Clinical Operations, Clinical Development, clinical research, or a related field within biotechnology, pharmaceuticals, or life sciences.
Hands-on Phase 1 and Phase 2 clinical trial experience within a small or emerging biotechnology company; experience with an outsourced/CRO operating model is preferred.
Progressive leadership experience, including building, leading, and developing high-performing Clinical Operations teams.
Demonstrated experience leading clinical trials and clinical development programs, with a strong understanding of ICH/GCP and applicable regulatory requirements.
Experience building and scaling Clinical Operations infrastructure, including processes, SOPs, quality systems, vendors, and operational capabilities.
Experience selecting and managing CROs and clinical vendors, overseeing external partners, and driving quality, timelines, and performance.
Experience managing clinical budgets, resources, timelines, and operational strategies.
Strong cross-functional collaboration and decision-making skills.
Ability to translate strategy into priorities and measurable outcomes, assess risks and alternatives, and make sound, timely decisions.
Ability to attract, develop, coach, and empower teams and future leaders.
Effective communication and relationship-building with executive leadership, cross-functional partners, investigators, CROs, vendors, and other external stakeholders.
Ability to work in a dynamic, entrepreneurial biotechnology environment and navigate evolving priorities and complex challenges.
Commitment to advancing high-quality clinical programs that improve patient outcomes.

Nice To Haves

Experience in a development-stage biotechnology environment and/or supporting early clinical development programs.
Advanced degree in a relevant scientific, healthcare, or business discipline.
Relevant clinical research certification, such as ACRP, SOCRA, or equivalent.
Experience using an outsourced/CRO operating model.

Responsibilities

Provide strategic leadership and overall accountability for Clinical Operations, aligning priorities, resources, capabilities, and operating models with the company’s clinical development strategy and growth.
Serve as a senior leadership team member, providing Clinical Operations expertise and strategic input on portfolio, program, organizational, and operational decisions.
Oversee clinical development programs and trials to support high-quality, timely, compliant, and efficient execution.
Partner with cross-functional teams to identify and manage operational risks, set priorities, and support clinical program delivery.
Build and lead a high-performing Clinical Operations organization, establishing the structure, capabilities, and talent needed for the evolving pipeline.
Recruit, develop, coach, and retain talent; establish clear priorities, roles, objectives, and accountability; and build future leadership capabilities.
Foster a culture of accountability, collaboration, quality, compliance, scientific and operational rigor, innovation, and continuous improvement.
Establish and oversee the Clinical Operations quality framework, including the Quality Management System, SOPs, processes, training, governance, and inspection readiness.
Improve Clinical Operations processes, systems, and ways of working to enhance quality, efficiency, scalability, and risk management.
Develop and oversee relationships with CROs, clinical vendors, investigators, sites, consultants, and other external partners.
Partner with the CMO and cross-functional leaders to advance clinical programs and align priorities, timelines, resources, risks, and operational strategy.
Provide strategic oversight of Clinical Operations budgets, resources, systems, and infrastructure, balancing quality, timelines, cost, capacity, and operational risk.
Establish governance, performance metrics, and reporting mechanisms to support visibility, accountability, decision-making, and execution.
Provide Clinical Operations leadership and expertise in clinical development planning, strategic initiatives, and organizational priorities, serving as a strategic advisor to executive leadership.
Establish and monitor key performance indicators, operational metrics, and risks to support informed decisions and continuous improvement.
Represent Clinical Operations with external stakeholders and maintain awareness of evolving clinical development practices, regulatory expectations, technologies, and industry trends.
Perform other duties consistent with the scope and level of the role.