About You:

You are a strategic and hands-on leader with deep expertise in clinical trial operations, passionate about advancing innovative diagnostics that improve patient care. You excel at driving the execution of complex clinical programs, building strong cross-functional relationships, and ensuring operational excellence from study design through completion. Your background includes significant experience in clinical operations leadership within biotech, diagnostics, or pharmaceutical settings, and you thrive in fast-paced, multidisciplinary environments. You are committed to quality, compliance, and the development of high-performing teams.

What You’ll Do:

• Lead the planning, execution, and oversight of global clinical trialsensuring alignment with organizational strategy, timelines, and budgets.

• Serve as the primary point of contact for operational management of clinical development strategy, collaborating closely with regulatory, medical affairs, and commercial teams.

• Oversee the selection, management, and performance of clinical trial sites, CROs, and clinical vendors, functional service providers to ensure high-quality execution and compliance with GCP, ICH, and regulatory requirements.

• Develop and implement clinical operations SOPs, guidelines, and best practices to optimize efficiency, quality, and compliance.

• Lead clinical trial site training, initiation and coordination

• Monitor clinical trial progress, including site activation, patient enrollment, data collection, and study close-out, proactively identifying and mitigating operational risks.

• Lead the development and management of clinical trial budgets, timelines, and resource planning, ensuring deliverables are met within scope and cost constraints.

• Guide the preparation and review of operational sections of regulatory submissions (e.g., IND, NDA, BLA) and support interactions with health authorities.

• Synthesize operational data and KPIs to inform program strategy and decision-making, providing regular updates to senior leadership.

• Coach, mentor, and develop the clinical operations team, fostering a culture of collaboration, accountability, and continuous improvement.

• Ensure timely and accurate documentation and reporting of all clinical operations activities, maintaining inspection readiness at all times.

• Own the Clinical Trial Master File for the completion and future potential audits

What You’ll Need:

• Bachelor’s degree in a scientific or health-related discipline required; advanced degree (MS, MPH, PharmD, or equivalent) preferred.

• 8+ years of progressive experience in clinical operations within the biotech, diagnostics, or pharmaceutical industry, including direct leadership of global clinical trials.

• Proven expertise in managing all aspects of clinical trials, including CRO/vendor oversight, site management, and operational budgeting.

• In-depth knowledge of ICH/GCP guidelines, FDA, EMA, and global regulatory requirements for clinical research.

• Demonstrated ability to lead, inspire, and develop high-performing teams in a cross-functional, matrixed environment.

• Strong project management, organizational, and problem-solving skills, with a track record of delivering complex projects on time and within budget.

• Excellent interpersonal, written, and verbal communication skills, with the ability to influence and collaborate at all levels of the organization.

• Proactive, innovative, and adaptable, with a commitment to continuous learning and operational excellence.

• Ability to travel domestically and internationally as required (up to 25-30%).

Bonus Points For:

• Experience in diagnostics, medical devices, or gene therapy clinical development.

• Familiarity with laboratory operations or biomarker-driven clinical trials.

• Prior experience in a high-growth or start-up biotech environment.

• Appreciation of puns!

Why Join Us?

At Vital Bio, you will:

• Lead clinical operations for programs that directly impact patient care worldwide.

• Be part of a collaborative, innovative team that values respect, dependability, and growth.

• Take ownership of your work while contributing to life-changing advancements in healthcare diagnostics.

• Grow professionally through exposure to cutting-edge science, clinical development, and regulatory strategy.

About Vital

Vital is revolutionizing point-of-care diagnostics with our VitalOne platform, delivering real-time care wherever patients are. Our mission is to democratize health technology, making healthcare more accessible and proactive.

Our global team of experts spans chemistry, software, engineering, and microfluidics. We thrive on change, operate on trust, and value diverse perspectives. Our growth-minded culture empowers front-line decision-making and fosters impactful work.

We seek tenacious, bold individuals ready to transform healthcare. At Vital, your talent will make a difference as we work to ensure everyone has access to care when and where they need it.

Vital Biosciences Inc. is an equal opportunity employer and values diversity in the workplace. We are therefore happy to accommodate any individual needs in keeping with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act. If you require accommodation in order to participate in our hiring process, please contact us to make your needs known in advance.