Clinical Business Operations Lead

Manufacturing & OperationsRemoteposted 4w ago

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

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.

Essential Functions and 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

Travel

Available to travel as needed

Preferred Education, Skills, and Knowledge

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)

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
Must be able to communicate with others to exchange information.

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

Work Environment

This job operates in a professional workplace or remote office environment and requires standard office equipment and keyboards. Employees who work remotely are expected to maintain their workspace and environment safely and free from safety hazards.

#LI-remote

The annual base salary we reasonably expect to pay is listed. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of the role, job duties/requirements, and relevant education, experience and skills.

Pay Transparency

$145,000—$155,000 USD

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.

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