Director of Clinical Operations

Elephas•Madison, WI

About The Position

The Director of Clinical Operations leads the strategy and execution of Elephas’ global clinical study portfolio in support of a functional precision medicine diagnostic platform. The role oversees multinational oncology studies, CRO and vendor performance, and the clinical operations team to deliver high-quality clinical evidence on time and within budget. The position partners closely with the Chief Medical Officer and cross-functional leadership, and its scope may scale based on experience. The Director develops a scalable global clinical operations strategy and owns study delivery from feasibility and country/site selection through study closeout and archival. The role manages timelines, budgets, resources, and risks; oversees CROs and other clinical vendors; supports quality, regulatory, and compliance activities; establishes portfolio reporting; and builds and mentors the clinical operations function as the portfolio grows. The position also manages external clinical research proposals and contributes to clinical documents for regulatory submissions.

Requirements

Bachelor’s degree or higher, ideally in the life or medical sciences.
At least 5 years of clinical operations experience.
Experience managing global clinical studies and partnering with international CROs, ethics committees, and central laboratories.
Knowledge of regulatory aspects concerning human subject research.
Experience in diagnostic, IVD, medical device, companion diagnostic, or biomarker-driven clinical development, particularly clinical performance studies.
Experience building clinical operations infrastructure.
Familiarity with applicable device/IVD regulatory and quality frameworks, such as ISO 20916, ISO 13485, FDA QMSR (21 CFR Part 820), U.S. FDA diagnostic pathways, EU IVDR, and India CDSCO requirements.
Strong understanding of good documentation practices.
Strong verbal, interpretation, and written communication skills.

Nice To Haves

At least 5 years of management experience.

Responsibilities

Develop and execute a scalable global clinical operations strategy across prospective observational, interventional, and diagnostic/biomarker studies, as appropriate to the development program.
Own operational delivery from protocol feasibility and country/site selection through start-up, enrollment, monitoring, database lock, study closeout, and archival; manage timelines, budgets, resources, and study risks.
Lead selection, due diligence, contracting, budgets, and oversight of global CROs, central laboratories, imaging providers, and other clinical vendors; define scopes of work, deliverables, governance, and performance metrics.
Hold vendors accountable for quality, timeliness, cost, and corrective actions while maintaining effective sponsor oversight.
Oversee site training and consistent execution of consent, eligibility, treatment and assessment schedules, protocol deviations, safety reporting, and clinical outcome collection according to study-specific requirements.
Ensure appropriate monitoring, EDC/CTMS/eTMF processes, vendor and site data review, medical/imaging review coordination, issue resolution, and inspection-ready study documentation.
Work with Clinical Development, Medical, Regulatory, Quality, R&D, Biostatistics, Laboratory Operations, Finance, and Commercial teams to align execution with clinical and business objectives.
In collaboration with Regulatory and Quality, support ethics and regulatory submissions, clinical performance evidence, GCP compliance, audit readiness, and responses to agency or ethics committee questions; regulatory submission ownership is not the primary focus.
Establish concise portfolio-level leadership reporting on enrollment, site activation, specimen success, data quality, milestone delivery, spend, and key risks; build and mentor the clinical operations function as the portfolio grows.
Manage external clinical research proposals, oversee corporate approval processes and execution of agreements, and ensure completion of milestones and reports.
Contribute to writing and reviewing clinical documents in regulatory agency submissions, including IDE, IVD, and 510(k) submissions.
Collaborate internally with R&D, Program Management, and Commercial areas.
Navigate resources, identify issues, and proactively problem solve.
Perform other duties as assigned.