Clinical Business Operations Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Monitor and report on the progress of the clinical portfolio, programs, and studies to Senior Management utilizing dashboards and tracking tools.

• Analyze data to identify trends and anomalies, proactively directing resources to resolve issues at an early stage.

• Establish and monitor key performance indicators (KPIs) for clinical operations and vendor performance.

• Facilitate program-level meetings and governance forums, covering logistics, minute-taking, and follow-up on action items.

• Develop strategies for clinical trial scenario planning, preliminary budget forecasting, and predictive enrollment analysis.

• Assist in the preparation of clinical study documents and provide eTMF support as required.

• Support inspection and audit readiness initiatives.

• Act as the clinical representative during hypercare and S&OP processes.

• Represent clinical interests on the Iovance Clinical Platform.

• Uphold the company’s values, policies, procedures, and ethical standards.

• Carry out various other duties as assigned.

• Travel as necessary.

⛳️ Requirements

• Bachelor’s degree with over 4 years of experience in pharmaceutical, biotech, clinical research, oncology, or related fields, or a Master’s degree with 3+ years of relevant experience.

• Proven experience in designing, initiating, and overseeing Phase 1–4 clinical trials.

• Background in managing Contract Research Organizations (CROs) and selecting ad hoc clinical trial vendors.

• Exceptional interpersonal and communication abilities, with demonstrated leadership qualities.

• In-depth knowledge of US and global regulations and guidelines, including SOPs, ICH-GCP, FDA-CFR, and ethical standards.

• Capability to remain in a stationary position, whether standing or sitting, for extended periods.

• Ability to navigate within an office setting and occasionally exert up to 10 pounds of force, or frequently engage in negligible force activities.

• Adequate visual acuity for data preparation and analysis, computer screen usage, and extensive reading tasks.

• Proficient in performing repetitive motions involving wrists, hands, and/or fingers.

• Effective communication skills for exchanging information with others.

• Strong conceptual thinking, judgment, troubleshooting, problem-solving, analytical skills, discretion, stress management, multitasking, and deadline management capabilities.

• Willingness to travel as required.

🏝️ Benefits

• Annual base salary ranging from $145,000 to $155,000 USD.

• Option for remote work.

• Reasonable accommodations available upon request.

• A diverse and inclusive workplace culture.

• Commitment to equal-opportunity employment.