About iBio
iBio is an AI-driven innovator developing therapies for cardiometabolic, obesity and cardiopulmonary diseases. iBio’s mission is to decrease drug failures, shorten development timelines, and open up new frontiers against the most promising therapeutic targets. iBio is based in San Diego, CA. For more information, visit www.ibioinc.com.
The Opportunity
Join iBio as Vice President, Clinical Operations!
iBio is seeking an accomplished and forward-thinking Vice President, Clinical Operations to join our leadership team and play a pivotal role in advancing our clinical development pipeline.
This is an exciting opportunity for a strategic leader to shape and scale our Clinical Operations function, build a high-performing team, and drive operational excellence across our clinical programs. Working closely with the Chief Medical Officer and cross-functional leaders, the successful candidate will help translate our clinical development strategy into effective execution and build the capabilities needed to support iBio’s continued growth.
If you are passionate about building high-performing teams, driving clinical execution, and making a meaningful impact in biotechnology, we invite you to explore this opportunity.
Location: Onsite — Sorrento Valley, San Diego, CA
Responsibilities:
Clinical Operations Leadership & Strategy
- Provide strategic leadership and overall accountability for Clinical Operations, aligning priorities, capabilities, resources, and operating models with the company’s clinical development strategy and growth.
- Serve as a senior member of the leadership team, providing Clinical Operations expertise and strategic input on portfolio, program, organizational, and operational decisions.
Clinical Development & Trial Operations
- Provide strategic oversight of clinical development programs and trials, ensuring high-quality, timely, compliant, and efficient execution.
- Partner with cross-functional teams to identify and manage operational risks, establish priorities, and support successful delivery of clinical programs.
Organization & Team Development
- Build and lead a high-performing Clinical Operations organization, establishing the structure, capabilities, and talent needed to support the company’s evolving clinical pipeline.
- Recruit, develop, and retain talent while fostering a culture of accountability, collaboration, quality, innovation, and continuous improvement.
Quality & Operational Excellence
- Establish and oversee an effective Clinical Operations quality framework, including the Quality Management System (QMS), SOPs, processes, training, governance, and inspection readiness.
- Drive continuous improvement in Clinical Operations processes, systems, and ways of working to enhance quality, efficiency, scalability, and risk management.
External Partnerships & Cross-Functional Leadership
- Develop and oversee strategic relationships with CROs, clinical vendors, investigators, sites, consultants, and other external partners to support effective program execution.
- Partner closely with the CMO and cross-functional leaders to advance clinical programs, align priorities, and make informed decisions regarding timelines, resources, risks, and operational strategy.
Resources, Budget & Governance
- Provide strategic oversight of Clinical Operations budgets, resources, systems, and infrastructure, balancing quality, timelines, cost, capacity, and operational risk.
- Establish appropriate governance, performance metrics, and reporting mechanisms to support visibility, accountability, informed decision-making, and effective execution across Clinical Operations.
Additional Responsibilities
- 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 decision-making and continuous improvement.
- Partner with cross-functional leaders and represent Clinical Operations with external stakeholders, including CROs, vendors, investigators, consultants, and other strategic partners.
- Maintain awareness of evolving clinical development practices, regulatory expectations, technologies, and industry trends, identifying opportunities to strengthen the company’s clinical development capabilities.
- Perform other duties consistent with the scope and level of the role.
Supervisory Responsibilities
- Lead and develop the Clinical Operations organization, establishing clear priorities, roles, objectives, and accountability aligned with the company’s clinical development strategy.
- Recruit, coach, develop, and retain high-performing talent while building organizational capabilities and future leadership to support the company’s growth.
- Foster a culture of accountability, collaboration, quality, compliance, scientific and operational rigor, innovation, and continuous improvement.
Education & Experience
- Bachelor’s degree with 15+ years of progressive experience, or Master’s degree with 13+ years of progressive experience, in Clinical Operations, Clinical Development, clinical research, or a related field within biotechnology, pharmaceutical, or life sciences.
- Hands-on Phase 1 and Phase 2 clinical trial experience within a small or emerging biotechnology company, preferably using an outsourced/CRO operating model.
- Progressive leadership experience, including experience 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, with the ability to effectively oversee external partners and drive quality, timelines, and performance.
- Experience managing clinical budgets, resources, timelines, and operational strategies, with strong cross-functional collaboration and decision-making skills.
- Experience in a development-stage biotechnology environment and/or supporting early clinical development programs is strongly preferred.
- Advanced degree in a relevant scientific, healthcare, or business discipline preferred.
- Relevant clinical research certification, such as ACRP, SOCRA, or equivalent, is preferred.
Leadership Competencies:
- Strategic Builder & Enterprise Leader: Builds scalable Clinical Operations capabilities and operating models while understanding broader business priorities and effectively influencing across organizational boundaries.
- Strategic & Results-Oriented: Translates strategy into clear priorities and measurable outcomes; anticipates challenges, evaluates risks and alternatives, and makes sound, timely decisions that drive successful execution.
- People & Culture Leader: Attracts, develops, coaches, and empowers high-performing teams and future leaders while fostering accountability, collaboration, and continuous improvement.
- Influential & Collaborative Communicator: Builds strong relationships and communicates effectively with executive leadership, cross-functional partners, investigators, CROs, vendors, and other external stakeholders.
- Adaptable Executive: Thrives in a dynamic, entrepreneurial biotechnology environment and effectively navigates evolving priorities, organizational needs, and complex challenges.
- Patient-Focused: Maintains a strong commitment to advancing high-quality clinical programs that ultimately improve outcomes for patients.
California Base Salary Range
The expected annual base salary for this position ranges from $267,417.00 to $354,483.00, plus bonus, equity, and comprehensive benefits. The base salary range reflects the target range for this position, but individual pay will be determined by various factors, including the qualifications of the individual applicant for the position, years of relevant experience, job-related skills, relevant education attained, work location, and organizational needs. This range may be modified in the future. A discretionary annual bonus may be available based on individual and Company performance.
All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identify, national origin, disability, veteran status or other protected classes.
What do we offer?
We provide competitive and comprehensive benefits to our employees. Below are some highlights of our benefits:
- Medical, Dental, and Vision Insurance Options
- Flexible Time Off
- Our company observes seven designated holidays each calendar year.
- 401(k) with Company Match as described in plan documents.
- Life and Disability Insurance
- Short-term and long-term disability insurance
EEO Statement
iBio is proud of its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.
iBio is committed to helping individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at iBio, please email ibio_peopleculture@ibioinc.com for further assistance. Please note that this email address is intended only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Notice to Recruiters
Thank you for your interest in iBio and our recruitment opportunities. Recruiting and employment are managed through the Human Resources Department. iBio requires a signed agreement be in place prior the presentation of any candidates. We ask that recruiters and agencies do not contact or solicit employees or managers in an attempt to present candidates. iBio will not be obligated or responsible for any requested fees to candidate resumes that are unsolicited and or submitted to hiring managers without a written agreement between iBio and any recruiters and agencies.