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Associate Director, Clinical Operations
Iovance Biotherapeutics, Inc.. Lead and manage the assigned Clinical Operations team .
About the role
Key responsibilities & impact- Lead and manage the assigned Clinical Operations team
- Help set and execute 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, pharmacovigilance, and other activities
- Maintain relationships with clinical study site personnel to ensure protocol adherence, Good Clinical Practice, quality data, and study timelines
- Oversee study conduct at centers, including site selection, start-up, monitoring, protocol/GCP adherence, guidance compliance, and study closure
- Contribute to clinical study protocols and protocol amendments
- Assist with Investigator Brochures, FDA Briefing Documents, and presentations
- Review Investigator Sponsored Trials and supporting documentation
- Contribute to internal SOPs and Clinical work practice documents aligned with FDA and EMA regulations
- Interface with the Chief Medical Officer/Medical Monitor and cross-functional teams
- 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 duties as assigned
Requirements
What you’ll need- Bachelor’s Degree in health or science-related area
- 8+ years of pharmaceutical, biotech-related, or clinical research experience
- Oncology/immuno-oncology experience required
- Experience leading Phase 1–4 trials and supporting investigator-initiated trials
- Success managing clinical studies within timeline and budget
- Managerial, interpersonal, verbal, and written communication skills
- Ability to build relationships across functional teams
- Ability to assimilate information quickly and implement needed changes
- Negotiating, influencing, and problem-solving skills
- Ability to maintain accountability and quality in deliverables
- Proactive, self-directed, adaptable approach
- Flexibility to perform necessary tasks in a fast-paced biotechnology environment
- 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 such as eClinical, Medidata RAVE, and InForm
- Exposure to Safety/Pharmacovigilance databases such as ARGUS
- Available to travel up to 20% of the time
- Ability to meet the stated physical, visual, communication, and mental demands of the role
Benefits
Comp & perks- Remote office environment
- Equal-opportunity and inclusive work environment
- Reasonable accommodations available upon request