Director, Clinical Operations

Karius•Redwood City, CA

13h•Hybrid

About The Position

The Director, Clinical Operations is responsible for building and leading a scalable, high-performance clinical operations function to support the execution of Kariusâ diagnostic clinical programs. This role goes beyond study execution to establish the systems, processes, and operating model required to deliver multi-site clinical trials with consistency, quality, and speed. The Director will define and implement the clinical operations infrastructure, including site management strategy, monitoring frameworks, performance metrics, and team structure, ensuring the organization is positioned to scale efficiently. Reporting to the SVP, Clinical Affairs, this individual will lead a growing Clinical Operations team and serve as the operational backbone across programs, enabling strong program leadership, proactive risk management, and inspection readiness.

Requirements

Bachelorâs degree in a scientific, clinical, or health-related field required; advanced degree preferred.
Minimum 10+ years of progressive clinical operations experience, preferably within diagnostics, biotech, medical device, or pharmaceutical organizations, including significant experience leading clinical studies and teams in a regulated environment.
Minimum 6+ years of strong people leadership experience, including building, managing and developing high-performing teams across multiple roles and levels.
Demonstrated experience building or scaling clinical operations infrastructure (e.g., processes, monitoring strategies, site management models) in a growing organization.
Experience establishing operational KPIs, dashboards, and performance management systems for clinical trials.
Proven ability to create structure and drive accountability in environments with junior or developing teams.
Demonstrated experience leading multi-site clinical studies from study start-up through closeout, including studies intended to support regulatory submissions.
Experience in diagnostic clinical trials required; experience in infectious disease diagnostics preferred.
Strong people leadership experience, including building, managing and developing high-performing teams across multiple roles and levels.
Strong project and program management experience, with the ability to manage multiple concurrent studies while ensuring consistency, quality, and execution against timelines and budgets.
Demonstrated experience managing clinical trial budgets, forecasting, resource planning, and external vendors, including CROs, consultants, and clinical sites.
Working knowledge of electronic data capture systems, with Medrio preferred, and CTMS and eTMF systems, with Veeva preferred.
In-depth understanding of human subjects research, ICH-GCP guidelines, and applicable FDA and CMS regulations.
Strong knowledge of clinical trial execution, including monitoring practices, data quality standards, and regulatory compliance requirements.
Proven ability to work effectively across cross-functional teams, influence stakeholders, and drive execution in a fast-paced and evolving environment.
Excellent written and verbal communication skills, with the ability to communicate effectively with scientific, clinical, operational, and executive stakeholders.
Demonstrated ability to operate effectively in a cross-functional environment, aligning diverse stakeholders and driving execution across competing priorities in a fast-paced setting.
Strong leadership presence with the ability to establish structure, set clear expectations, and drive accountability across teams and external partners.
Strategic and operational leader who can translate business, clinical, and regulatory objectives into clear, executable plans and scalable operating models.
Excellent judgment and problem-solving skills, with the ability to identify root causes, assess risk, and implement practical, effective solutions.
Proven ability to influence and communicate effectively across all levels of the organization, including scientific, operational, and executive stakeholders.
Strong interpersonal and organizational skills, with the ability to build trust, foster collaboration, and drive alignment across functions.
Demonstrated ownership mindset, with a high degree of independence, initiative, and accountability for outcomes.
Ability to balance strategic leadership with appropriate operational engagement, knowing when to dive deep and when to delegate.
Experience managing external partners (e.g., CROs, vendors, contractors) with clear expectations, performance oversight, and accountability.
Commitment to quality, compliance, and operational excellence, with strong attention to detail in a regulated environment.

Responsibilities

Clinical Operations Strategy & Infrastructure
Design and implement a scalable clinical operations model to support multi-study, multi-site execution across OPTIMUM, AXIS, and future programs.
Establish standardized processes, tools, and playbooks for site start-up, monitoring, enrollment management, and study oversight.
Define and implement key performance indicators (KPIs) and dashboards to monitor study health (e.g., enrollment, data quality, protocol deviations, site performance).
Build and continuously improve systems to ensure consistent, inspection-ready execution across all studies.
Site Operations & Monitoring Excellence
Define and oversee the site management and monitoring strategy, ensuring appropriate resource allocation, monitoring models, and site engagement approaches.
Lead and develop the site operations function, including oversight of CRAs, contractors, and site-facing personnel.
Ensure consistent, high-quality monitoring practices and proactive issue identification and escalation across sites.
Partner with the Sr. Manager, Site Operations (or equivalent) to drive day-to-day execution excellence.
Operational Oversight & Risk Management
Establish clear oversight mechanisms to ensure visibility into study performance, including enrollment, data entry compliance, protocol deviations, and site activation timelines.
Proactively identify operational risks and implement mitigation strategies, including root cause analysis and corrective/preventive actions (CAPA).
Ensure strong governance and accountability across all levels of the clinical operations team.
Team Design & Development
Build and evolve the Clinical Operations team structure to support scale, including defining roles, responsibilities, and development pathways across CTMs, CRAs, and support staff.
Coach and develop junior team members (e.g., Clinical Trial Managers) to grow into program leadership roles within a structured and supportive framework.
Ensure appropriate layering of responsibilities between program leadership and site execution.
Ensure effective execution of clinical trials through a structured operating model that enables consistency across programs rather than reliance on individual contributors.
Mentor and develop Clinical Operations team members, providing guidance, training, coaching, and support to foster professional growth, accountability, and excellence in performance.
Build and strengthen a high-quality, scalable Clinical Operations team and infrastructure capable of supporting the organizationâs clinical and regulatory objectives.
Manage all clinical trial budgets, resource allocation, and forecasting to ensure efficient execution within budget.
Collaborate cross-functionally with Clinical Development, Data/Stats, and external partners to ensure aligned and effective study execution
Oversee vendor and CRO performance to ensure accountability, quality, and delivery against study objectives.
Maintain an ongoing overview of program status, issues, risks, and dependencies, and proactively communicate progress, changes, issues, and risk mitigation strategies that may impact timelines, quality, or costs to all stakeholders.
Ensure adherence to ICH-GCP and all applicable guidelines, regulations, internal procedures, and quality standards.