Director of Clinical Operations

Summary/Objective

The Director of Clinical Operations will lead the strategy for execution of Elephas’ global clinical study portfolio supporting a novel functional precision medicine diagnostic platform. This leader will oversee multinational oncology studies, direct CRO and vendor performance, and lead the clinical operations team to ensure high-quality clinical evidence that is on time and within budget. This position partners closely with the Chief Medical Officer and cross functional leadership. Role can scale based on experience.

Job Duties

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 closely with Clinical Development, Medical, Regulatory, Quality, R&D, Biostatistics, Laboratory Operations, Finance, and Commercial teams to align execution with clinical and business objectives

Work closely 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 of this role

Establish concise portfolio-level reporting for leadership 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.

Manages external clinical research proposals, overseeing corporate approval processes, execution of agreements, completion of milestones and reports

Contributes to writing and reviewing clinical documents in regulatory agency submissions (IDE, IVD, 510k, etc.)

Collaborates internally with R&D, Program Management and Commercial areas

Navigates resources, identify issues and proactively problem solve

Performs other duties as assigned

Competencies

Experience managing global clinical studies and partnering with international CROs, ethics committees, and central laboratories and 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 device/IVD regulatory and quality frameworks, as applicable, such as ISO 20916, ISO 13485, the FDA QMSR (21 CFR Part 820), U.S. FDA diagnostic pathways, EU IVDR, and India CDSCO requirements.

Strong understanding of good documentation practices

Expert verbal, interpretation, and written communication skills

Required Education and Experience

Bachelor’s degree or higher, ideally in the life or medical sciences

5 + years of clinical operations experience

5+ years of management experience preferred

We offer our employees competitive compensation and benefits, including paid time off, health insurance, life insurance, flexible spending accounts, a 401(k) plan, and stock options.

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.