Director of Clinical Operations

Elephas; Madison (WI); On-site; USD 180,000 - 250,000; Full time

Benefits offered by this job

Paid time off

Health insurance

Life insurance

Flexible spending accounts

401(k) plan

Stock options

Job summary

Elephas is seeking a Director of Clinical Operations to lead the strategy for its global clinical study portfolio, overseeing multinational oncology studies and CRO/vendor performance. The role partners with the Chief Medical Officer and cross-functional leadership to ensure on-time, on-budget delivery of high-quality clinical evidence.

Role can scale based on experience, with oversight of feasibility, site selection, start-up, enrollment, monitoring, and reporting.

Qualifications

• Bachelor’s degree or higher, ideally in life or medical sciences.
• 5+ years of clinical operations experience.
• 5+ years of management experience preferred.

Responsibilities

• Develop and execute a scalable global clinical operations strategy across study types.
• Own end-to-end operational delivery from feasibility to archival; manage timelines and budgets.
• Lead selection, contracting, budgets, and oversight of CROs and vendors.
• Ensure vendor accountability for quality, timeliness, and costs.
• Oversee site training and protocol execution per study requirements.
• Maintain monitoring, EDC/CTMS/eTMF processes and data review.
• Collaborate with R&D, Regulatory, Quality, and Commercial teams.
• Support ethics and regulatory submissions and inspection readiness.

Skills

Global clinical studies management

Vendor management

Regulatory/compliance knowledge

Leadership

Education

Bachelor's degree or higher in life/medical sciences

Tools

EDC/CTMS/eTMF

Job description

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.

• Paid time off
• Health insurance
• Life insurance
• Flexible spending accounts
• a 401(k) plan
• 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.