Director, Clinical Science

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

📋 Description

• Engage in the Clinical Development Core Team, Clinical Sub-Team, and operational meetings.

• Collaborate with cross-functional teams, including Biomarkers, Biometrics, Clinical Operations, Regulatory Affairs, Quality Assurance, Translational Medicine, and others.

• Assist in the formulation of clinical science strategies, Lifecycle Plans, commercialization plans, and Clinical Trial Plans.

• Collect and analyze data and information for Clinical Science plans.

• Provide clinical science support for designated studies and programs.

• Perform literature searches and contribute insights on clinical study designs.

• Create clinical protocols, manuals, and forms under the guidance of Medical Directors/Clinical Science Physicians.

• Develop and review informed consent documents, eligibility criteria, dose modification protocols, safety measures, case report forms, protocol summaries, monitoring plans, investigator brochures, and associated documentation.

• Organize document finalization, protocol modifications, site training, and clinical review of study data.

• Evaluate and discuss clinical study reports and safety-related documents.

• Prepare materials for clinical presentations, abstracts, posters, scientific meeting content, and regulatory submissions.

• Support communication strategies involving KOL interactions, advisory boards, medical meetings, publications, and study-related communications.

• Facilitate submissions to scientific meetings and regulatory agencies.

• Complete or oversee special projects while adhering to laws, regulations, Iovance SOPs, and guidelines.

⛳️ Requirements

• Over 7 years of clinical trial experience, with relevant therapeutic area expertise.

• At least 2 years of experience in clinical science.

• Mandatory experience in data listing reviews.

• Proven experience in authoring experimental protocols and/or study results and conclusions.

• Comprehensive understanding of Phase 1 through 4 drug development processes.

• Strong analytical skills for interpreting scientific research and literature.

• Experience with data analysis, interpretation, and clinical significance.

• In-depth knowledge of product and safety profiles.

• Familiarity with GCP, ICH, FDA, EMEA, NICE, and other pertinent guidelines and regulations.

• Proficient in computer skills, particularly Microsoft Office Suite (Word, PowerPoint, and Excel).

• Working knowledge of multidisciplinary drug development functions.

• Excellent project management, prioritization, and budget/timeline management capabilities.

• Strong interpersonal, verbal, written communication, influencing, presentation, judgment, and decision-making abilities.

• Willingness to travel approximately 25% of the time.

• Capability to sit for extended periods in front of a computer.

🏝️ Benefits

• Comprehensive health insurance plans.

• Competitive salary and performance bonuses.

• Opportunities for professional development and training.

• Flexible work hours and remote work options.

• Generous paid time off and holiday schedule.