Director, Clinical Operations ( Remote )

Overview
The Director, Clinical Operations, will lead and manage the assigned clinical operations team and have a key role in setting and executing departmental strategy.
Specific Responsibilities

• Works with VP, Clinical Operations and Senior Director, Program Management to develop detailed timelines and budgets for each clinical program to meet management goals
• Establishes and maintains good working relationships with clinical study site personnel to ensure adherence to protocols and Good Clinical Practice (GCP), provision of quality data and adherence to study timelines
• Contributes to the review of Investigator Sponsored Trials (ISTs) & the relevant documentation to support these trials.
• Contributes to the creation of internal Iovance Biotechnologies SOPs & Clinical work practice documents and implementation of these plans for Clinical Operations to operate in accordance with FDA & EMA regulations
• Oversees clinical trial agreements, budgets, expenditures and payments for clinical studies
• Key contributor to the preparation and management of clinical study protocols and protocol amendments
• Assists with preparation of key documents e.g. Investigator Brochures, FDA Briefing Documents, internal or external presentations, etc.
• Key contributor to the creation and implementation of clinical program feasibility and development plan
• Interfaces with Chief Medical Officer/Medical Monitor and cross-functional team members including Data Management, Drug Safety, Logistics/Manufacturing, Project Management, Regulatory Affairs, and Biostatistics
• Ensures the timely execution of clinical research programs/protocols from conception through final clinical study report. This will generally involve close supervision of external contract organizations who will have responsibility for site interaction, site monitoring, data management, biostatistics, IRB interaction, central laboratory function, clinical research budget negotiation, medical writing, pharmacovigilance, and other critical activities
• Other duties as assigned
• Serve as company representative at external meetings, scientific congresses, etc.
• Provide direct supervision of Clinical Operations team members, including performance management and development planning

Education And Qualifications

• Flexible and dynamic approach to working in a fast-paced biotechnology company; willing to perform all necessary tasks, regardless of level, to facilitate success at driving a project/program to completion
• Proactive, self-directed, able to thrive and adapt in a rapidly changing environment
• Bachelor’s Degree or Master’s in sciences, health, or related area (advanced degree, preferred)
• Demonstrated experience in core and technical aspects of leading phase 1-4 and supporting Investigator-initiated trials
• Embraces the ideas of others, promotes innovation and manages goals to reality
• Able to assimilate information quickly, grasping critical factors and risks, while implementing immediate change where/when needed
• Able to build strong relationships with peers and partners both within and across functional teams to engage high performance
• Demonstrated managerial skills and strong interpersonal and communication (verbal and written) skills in interacting with clinical monitors, investigators, and various individuals in specialized areas or internal groups to facilitate translational, clinical and correlative research
• In depth knowledge of PC operating systems; Microsoft Office, including MS Word, MS Excel, MS PowerPoint, MS Project, MS Publisher, MS Outlook, and MS Windows NT,
• Able to set a high level of accountability and quality in deliverables
• Proven experience in using negotiating, influencing, and problem solving skills in order to meet study timelines
• Exposure to CTM systems, EDC systems (eClinical, Medidata RAVE, InForm) and Safety/ Pharmacovigilance databases (ARGUS)
• Available to travel up to 20% of the time
• Demonstrated success in managing clinical studies within timeline and budget
• 12 years of pharmaceutical or biotech-related/clinical research experience (oncology/ immuno-oncology experience required)

Physical Requirements

• Sit for an extended time in front of a computer

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