Senior Clinical Scientist [Contract]

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 Senior Clinical Scientist participates in support of the Clinical Development plans (CDPs) and supports the assigned Medical Director/Clinical Science Physician(s) with various deliverables necessary for effective and efficient CS plan execution for the assigned assets/indication(s).

The Senior Clinical Scientist has primary responsibilities for supporting Medical Directors/Clinical Science Physicians with clinical documentation, representing Clinical Science on various teams/sub-teams or other appropriate forums, and supporting training of study site and/or CRO personnel. The Senior Clinical Scientist is expected to perform their responsibilities with independence and are likely to have external interactions with cooperative groups, key opinion leaders (KOLs), and external vendors supporting the work of Clinical Science. 

Specific Responsibilities 

• Supports the design and writing of clinical protocols and associated clinical study documents (e.g., ICFs, charters, operational manuals, etc.)
• Serves as an expert on the clinical study design (including trial procedures and requirements) and develops training materials to ensure quality execution by the investigational sites.
• Supports cross-functional teams with study protocol and related questions and serves as point of contact for managing/answering questions relating to trial procedures.
• Provides medical monitoring support or oversight of activities conducted by a CRO, which includes monitoring, cleaning, analyzing, and reviewing efficacy and safety data to establish the presence or absence of trends and follow up as appropriate
• Collaborates on, or leads where appropriate, the writing of clinical sections of key program documents including Investigational New Drug submissions, Investigator Brochures, Clinical Study Reports, and other global regulatory submissions and responses.
• Supports clinical development planning by participating in the evaluation of innovative trial designs and provisioning and analyzing data from ongoing and/or completed clinical trials to support future planning
• Maintains awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.

Education and Qualifications

• MD, PhD, OD, or PharmD with oncology experience required.
• Cell Therapy experience preferred.
• 6+ years of experience in a clinical research-related role. 3-5 years' experience in a Clinical science/development role preferred.
• Proficient knowledge of GCP/ICH, drug development process, study design, statistics, understanding of functional and cross-functional relationships
• Proficient knowledge and skills to support program specific data review, trend identification, data interpretation, data cleaning
• Experience with Spotfire and/or other data capture tools preferred
• Knowledge of melanoma or sarcoma therapies preferred but not required
• Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
• Previous experience working with CROs and other vendors/suppliers preferred
• Previous experience with Phase I-III US and Global/Ex-US clinical trials preferred
• Data listing review experience required
• Strong analytical skills, especially with regard to understanding and interpreting scientific research and literature
• Experience in the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
• Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel)
• Good business acumen; has working knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g. clinical operations, biostatistics, safety, regulatory, commercial operations, etc.
• Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment
• Good inter