Director, Clinical Operations

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

📋 Description

• Lead and manage the designated clinical operations team while contributing to the overall departmental strategy.

• Oversee clinical trial agreements, budgets, expenditures, and payment processes.

• Ensure the timely execution of clinical research programs and protocols from inception through to the final clinical study report.

• Supervise external contract organizations engaged in site interaction, monitoring, data management, biostatistics, IRB interaction, central laboratory functions, budget negotiations, medical writing, and pharmacovigilance.

• Build relationships with personnel at clinical study sites and ensure adherence to protocols, Good Clinical Practice, data quality, and timelines.

• Oversee the conduct of studies at centers, including site selection, start-up, monitoring, protocol/GCP adherence, applicable guidance, and study closure.

• Contribute to the development of clinical study protocols and any necessary amendments.

• Assist with Investigator Brochures, FDA Briefing Documents, and internal or external presentations.

• Review Investigator Sponsored Trials and their supporting documentation.

• Contribute to Iovance SOPs and Clinical work practice documentation, implementing plans that align with FDA and EMA regulations.

• Collaborate with the Chief Medical Officer/Medical Monitor and cross-functional teams, including Data Management, Drug Safety, Logistics/Manufacturing, Project Management, Regulatory Affairs, and Biostatistics.

• Directly supervise Clinical Operations team members, focusing on performance management and development planning.

• Represent the organization at external meetings and scientific congresses.

• Adhere to company values, policies, procedures, and business ethics.

• Perform various assigned duties.

⛳️ Requirements

• Bachelor’s Degree in a health or science-related field.

• 12 to 16 years of experience in pharmaceutical or biotech-related clinical research, with a focus on oncology/immuno-oncology.

• Proven experience leading phase 1–4 studies and supporting Investigator-initiated trials.

• Demonstrated success in managing clinical studies within established timelines and budgets.

• Strong managerial skills along with excellent verbal and written communication abilities.

• Capability to build strong relationships across functional teams.

• Ability to quickly assimilate information and implement immediate changes when necessary.

• Proficient in negotiating, influencing, and problem-solving.

• Capacity to maintain accountability and quality in deliverables.

• Proactive, self-directed, adaptable, and able to excel in a rapidly changing environment.

• Flexible and dynamic approach suitable for a fast-paced biotechnology company.

• Extensive knowledge of PC operating systems and proficiency in Microsoft Office, including Word, Excel, PowerPoint, Project, Publisher, Outlook, and Windows NT.

• Familiarity with CTM systems, EDC systems (eClinical, Medidata RAVE, InForm), and Safety/Pharmacovigilance databases (ARGUS).

• Willingness to travel up to 20% of the time.

• Must meet specified physical and mental demands, including prolonged sitting or standing, computer usage, repetitive wrist/hand/finger motions, communication, judgment, troubleshooting, analysis, discretion, multitasking, and meeting deadlines.

🏝️ Benefits

• Equal-opportunity employment.

• Reasonable accommodations available upon request.

• Remote office environment.