Clinical Business Operations Lead

Iovance Biotherapeutics

7d•$145,000 - $155,000•Remote

About The Position

The Clinical Business Operations Lead plays a critical role in supporting program-level enrollment planning and capacity forecasting across the clinical portfolio. This position leads the development and management of clinical operations and vendor KPIs, ensuring transparency and accountability through routine tracking and dashboard reporting to senior leadership. The ideal candidate brings strong analytical and operational skills, with the ability to oversee high-level program metrics while remaining agile to support study-level needs, including document development and eTMF support, as resourcing requires. This role is pivotal in driving operational excellence, cross-functional coordination, and informed decision-making throughout clinical development.

Requirements

Bachelor’s degree with 4+ years of pharmaceutical or biotech-related/clinical research, oncology or research experience or Master’s degree with 3+ years of pharmaceutical or biotech-related/clinical research, oncology or research experience
Demonstrated experience in core and technical aspects of designing, initiating and managing phase 1-4 clinical trials
Demonstrated experience in management of CROs, and clinical trial ad hoc vendor selection
Possessing excellent interpersonal and communication skills, with demonstrated leadership attributes
Positioned as a subject matter expert in application of US and Global Regulations and Guidance (SOPs, ICH-GCP, FDA-CFR, ethical standards)

Responsibilities

Effectively tracks and communicate clinical portfolio/program/study progress to Senior Management with ability to create and update detailed dashboards and trackers
Critically assess data to detect trends and outliers to efficiently direct resources and attention to correct problems early
Assist with the development and tracking of key performance indicators internally for clinical operations and vendor performance
Support program level meetings and governance forums including meeting set up, meeting minutes, and action item follow up
Create action-oriented solutions for clinical trial scenario planning including but not limited to early budget planning templates, predictive enrollment forecasting, etc
When needed contributor to the preparation and management of clinical study documents or eTMF support
Assist with inspection or audit readiness activities
Serve as clinical representative at hypercare and S&OP
Serve as clinical representative on the IovanceClinical Platform
Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
Perform miscellaneous duties as assigned