Director, Clinical Operations

Iovance Biotherapeutics, Inc.

. Lead and manage the assigned clinical operations team and contribute to departmental strategy .

Posted 9/17/2026full-timeRemote • United StatesLead💰 $225,000 - $240,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in managing clinical operations, including oversight of clinical trial agreements, budgets, and adherence to Good Clinical Practice. Proven ability to lead cross-functional teams and ensure timely execution of clinical research programs in compliance with FDA and EMA regulations.

Highest-signal resume keywords

Clinical Operations ManagementOncology/Immuno-Oncology ExperiencePhase 1–4 Clinical Trials LeadershipBudget ManagementStrong Verbal and Written Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial AgreementsClinical Research ProgramsProtocol DevelopmentData ManagementBiostatisticsPharmacovigilanceInvestigator-Initiated TrialsGCP AdherenceBudget NegotiationPerformance Management

Soft Skills

Relationship BuildingNegotiating SkillsProblem-Solving SkillsAdaptabilitySelf-Directed

Tools & Technologies

Microsoft OfficeCTM SystemsEDC SystemsEClinicalMedidata RAVEInFormARGUS

Industry Keywords

PharmaceuticalBiotechClinical ResearchGood Clinical PracticeFDA RegulationsEMA Regulations

About the role

Key responsibilities & impact

Lead and manage the assigned clinical operations team and contribute to departmental strategy
Oversee clinical trial agreements, budgets, expenditures, and payments
Ensure timely execution of clinical research programs and protocols from conception through final clinical study report
Supervise external contract organizations responsible for site interaction, monitoring, data management, biostatistics, IRB interaction, central laboratory functions, budget negotiation, medical writing, and pharmacovigilance
Establish relationships with clinical study site personnel and ensure protocol, Good Clinical Practice, data-quality, and timeline adherence
Oversee study conduct at centers, including site selection, start-up, monitoring, protocol/GCP adherence, applicable guidance, and study closure
Contribute to clinical study protocols and protocol amendments
Assist with Investigator Brochures, FDA Briefing Documents, and internal or external presentations
Review Investigator Sponsored Trials and supporting documentation
Contribute to Iovance SOPs and Clinical work practice documents and implement plans aligned with FDA and EMA regulations
Interface 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, including performance management and development planning
Represent the company at external meetings and scientific congresses
Adhere to company values, policies, procedures, and business ethics
Perform miscellaneous assigned duties

Requirements

What you’ll need

Bachelor’s Degree in health, or science related area
12 to 16 years of pharmaceutical or biotech-related/clinical research experience, with oncology/immuno-oncology experience required
Demonstrated experience leading phase 1–4 and supporting Investigator-initiated trials
Demonstrated success managing clinical studies within timeline and budget
Demonstrated managerial skills and strong verbal and written communication skills
Ability to build strong relationships across functional teams
Ability to assimilate information quickly and implement immediate change when needed
Negotiating, influencing, and problem-solving skills
Ability to maintain accountability and quality in deliverables
Proactive, self-directed, adaptable, and able to thrive in a rapidly changing environment
Flexible and dynamic approach in a fast-paced biotechnology company
In-depth knowledge of PC operating systems and Microsoft Office, including Word, Excel, PowerPoint, Project, Publisher, Outlook, and Windows NT
Exposure to CTM systems, EDC systems (eClinical, Medidata RAVE, InForm), and Safety/Pharmacovigilance databases (ARGUS)
Available to travel up to 20% of the time
Must meet stated physical and mental demands, including prolonged sitting or standing, computer use, repetitive wrist/hand/finger motions, communication, judgment, troubleshooting, analysis, discretion, multitasking, and meeting deadlines

Benefits

Comp & perks

Equal-opportunity employment
Reasonable accommodations available upon request
Remote office environment