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 Director, Regulatory CMC, is responsible for leading one or more drug development programs, with specific emphasis on global regulatory strategy, regulatory submissions, and interaction with global regulatory authorities. The individual must have a good understanding of clinical development strategies and health authority expectations for novel and complex oncology programs.

Essential Functions and Responsibilities

• Works closely with functional leaders to 1) create the optimal development path for Iovance product candidates, 2) negotiate optimal development paths within internal cross-functional teams and with health authorities, 3) execute clinical-regulatory development plans on-time and while managing all identified risks.
• Plans, manages, and creates Clinical Trial Applications, Market Applications and amendments.
• Ensures that submission documents and correspondence are of the highest quality in terms of content, organization, clarity of writing, and accuracy.
• Leads cross-functional teams in preparing for health authority meetings.
• Ensures that evolving global regulations, guidelines and health authority expectations, especially those related to cell therapies, are incorporated into program decision making.
• Works within the department and with other functional areas on process improvements.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Required Education, Skills, and Knowledge

• BS degree in life sciences.
• Minimum 10 years’ experience in regulatory affairs
• Late-stage experience in oncology drug development.
• Experienced in creating and negotiating the clinical-regulatory aspects of oncology programs.
• Able to write, edit, and/or collaborate on the development of high-quality clinical-regulatory documents. E.g., briefing books, investigator brochures, protocols, clinical study reports, clinical summaries.
• Able to write clearly and concisely, within agreed timelines.
• Able to simultaneously manage multiple projects and submissions, with flexibility to pivot based on new data, program changes, and/or external influences.
• High attention to detail and accuracy.
• High organizational and planning skills.
• Able to influence and negotiate professionally at various levels within cross-functional teams and with external partners, while maintaining positive working relationships.
• Excellent interpersonal, verbal and written communication skills

Preferred Education, Skills, and Knowledge

• Advanced degree preferred (PhD, MS, PharmD)
• Experienced in the creation, submission, and negotiation of market applications preferred.

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 or remote office environment and requires operating standard office equipment and keyboards.

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