AIM OF THE POSITION

The Director, Clinical Operations provides strategic, operational, financial, and quality leadership for Agendia-sponsored clinical studies, registries, and post-market evidence-generation activities. The Director oversees CROs, data-management partners, vendors, sites, budgets, systems, and cross-functional delivery, with particular responsibility for sustaining and strengthening FLEX operations while building scalable capabilities for Agendia's broader clinical-study portfolio.

POSITION WITHIN THE ORGANIZATION

1. Reports to the Vice President, Clinical Development.

2. Cooperates with Clinical Science, MSLs, Data Management, QA/RA, Legal, Finance, Lab Operations, Product Development, Market Access, Commercial, and Marketing.

3. Leads and organizes clinical operations activities within Clinical Development.

4. Provides sponsor oversight of CROs and other clinical service providers, and study-specific vendors.

5. Participates in and, as assigned, chairs:

– Study governance meetings

– Vendor governance meetings

– Investigator meetings

– Project teams and working groups

– Cross-functional portfolio reviews

ESSENTIAL DUTIES AND RESPONSIBILITIES

o Lead the full lifecycle of Agendia-sponsored clinical studies and registries, from protocol and operational-plan development, feasibility, site selection, contracting, budgeting, and IRB/EC activities through activation, enrollment, monitoring, amendments, and close-out.

o Provide oversight and execution for FLEX clinical operations and data-management activities, maintaining an integrated view of enrollment and participant status and Agendia accountability for data quality, governance, scientific use, treatment and outcomes capture, and long-term follow-up, including substudies, biospecimen programs, and approved expansion.

o Oversee CRO execution of site start-up, site management, monitoring, data cleaning, query resolution, eTMF/CTMS activities, regulatory maintenance, and operational reporting.

o Identify, qualify, select, and manage CROs, data-management providers, technology vendors, and consultants; establish vendor governance, KPIs, escalation paths, change control, and inspection-ready documentation of sponsor oversight.

o Manage clinical operations budgets, scopes of work, change orders, invoices, and site and vendor payments; partner with Finance and Legal to resolve delayed or disputed payments.

o Support site engagement and performance by cultivating relationships with investigators, coordinators, and KOLs, conducting investigator meetings and training, and managing site metrics with remediation and escalation plans for at-risk sites.

o Partner with Clinical Science, Biostatistics, Bioinformatics, and Data Management to maintain controlled data flows and cross-system reconciliation, prioritize data cleaning, and confirm data readiness for analyses, publications, and regulatory use.

o Provide operational ownership of clinical systems (EDC, CTMS, eTMF, ePRO, dashboards) and define KPIs and quality indicators to identify systemic risks and improve study performance.

o Ensure studies are conducted in accordance with applicable FDA regulations, ICH E6(R3) GCP, applicable ISO standards, EU IVDR, privacy requirements, approved protocols, and Agendia SOPs.

o Support FDA and other regulatory submissions, including, as applicable, Pre-Submissions, IDEs, 510(k)s, De Novo requests, PMAs, and IVDR submissions, in partnership with QA/RA by ensuring clinical study conduct, data, and documentation support applicable submission requirements and responses to agency questions.

o Lead audit and inspection readiness, support the resolution of findings and implementation of corrective and preventative actions, and ensure protocol deviations, safety information, and data-integrity issues are identified and escalated.

o Develop and maintain clinical operations SOPs, work instructions, templates, RACI matrices, and training materials; define operational responsibilities, decision rights, and cross functional handoffs;  and lead operational readiness for expansion into prospective or interventional research.

The above listing represents the general duties considered essential functions of the job and is not to be considered a detailed description of all work requirements that may be inherent in the position.

KEY CONTACTS

Internal

o Clinical Development/Clinical Science; Medical Affairs and Field Medical; Biostatistics; Bioinformatics; Data Management; QA/RA; Legal; Finance; Lab Operations; Product Development; Market Access; Commercial; Marketing; IT and Information Security.

External

o Investigators, research coordinators, participating sites, KOLs, IRBs/ECs, CROs, data-management partners, technology vendors, consultants, research networks, and other study collaborators.

EDUCATION AND EXPERIENCE REQUIREMENTS

EDUCATION

o Bachelor's degree in life sciences, nursing, pharmacy, public health, clinical research, or a related field required.

o Advanced scientific, clinical, or business degree preferred.

EXPERIENCE

o 8–10 years of progressively responsible clinical operations experience in diagnostics, medical device, biotechnology, or pharmaceutical development, including at least 3 years leading vendors, or complex matrixed study teams.

o Demonstrated experience leading observational registries and/or post-market clinical evidence programs; experience with prospective interventional studies a plus.

o Demonstrated sponsor oversight of multi-site studies from start-up through close-out, including CROs, data-management providers, budgets, contracts, monitoring, longitudinal follow-up, and data-quality remediation, and experience preparing for audits and inspections.

o Experience in oncology, molecular diagnostics, genomics, or breast cancer preferred.

KNOWLEDGE, SKILLS AND ABILITIES (KSA’S)

o Expert knowledge of clinical research operations and sponsor oversight, including ICH E6(R3) GCP, ISO 20916, ISO 14155, and 21 CFR Parts 11, 50, 56, 812, and 820 (QMSR).

o Working knowledge of FDA IVD regulatory pathways (Pre-Submission, IDE, 510(k), De Novo, PMA), EU IVDR, ISO 13485, CLIA, HIPAA, and GDPR as they apply to clinical evidence and regulatory submissions.

o Ability to translate scientific objectives into executable protocols, operational plans, budgets, and vendor deliverables across registry, real-world evidence, post-market, and interventional study models.

o Proficiency with EDC, CTMS, eTMF, and reporting dashboards; familiarity with Salesforce and OpenClinica is desirable.

o Strong financial and vendor-management skills, including budgeting, forecasting, accruals, invoice review, contract negotiation, and escalation.

o Strong analytical and problem-solving skills, with the ability to identify systemic trends across study, site, vendor, and data-quality metrics.

o Clear written and verbal communication skills, from executive updates to investigator training and cross-functional facilitation.

· PRIVACY NOTICE:  To review the California privacy notice, click here:  https://agendia.com/privacy-policy/ 

· Employees must not be classified as an excluded individual who is prohibited from participation in any Federal health care program.

BEHAVIOURAL COMPETENCIES/DESIRED SKILLS

o Strategic and systems-oriented thinking

o Accountability, follow-through, and attention to detail

o Quality and patient focus

o Sound judgment and timely escalation

o Collaborative, inclusive leadership and influence without authority in a remote, matrixed environment

o Adaptability and a continuous-improvement mindset

WORKING ENVIRONMENT

Remote position (U.S.-based). Regularly works on a computer and participates in virtual meetings, with availability across U.S. time zones as needed.

ENVIRONMENT/SAFETY/WORK CONDITIONS

o Regularly sits, communicates, and works on a computer for extended periods.

o Occasionally attends FLEX summits, site visits, investigator meetings, and congresses, and must follow site-specific safety and access requirementsMay occasionally handle or observe clinical-study materials; no routine laboratory work is anticipated unless separately assigned and trained.

TRAVEL

Travel approximately 5–10%, primarily for the annual FLEX summit and regional FLEX summits as scheduled, with occasional site visits, investigator or vendor meetings, audits, and scientific congresses. Overnight travel required; international travel occasional.

OTHER DUTIES

Other duties as required.