Job Type
Full-time
The OpportunityJoin 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.
Requirements
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 RangeThe 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.
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
Salary Description
$267,417.00 to $354,483.00
