Director, Clinical Operations
New
I
Iovance BiotherapeuticsBiotechnology
RemoteFull-TimeDirector
Salary225,000 - 240,000 USD per year
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Job Details
- Experience
- 12 to 16 years
- Required Skills
- GCPBudget management
Requirements
- Bachelor’s Degree in health or science related area.
- 12 to 16 years of pharmaceutical or biotech-related/clinical research experience.
- Oncology or immuno-oncology experience.
- Demonstrated experience leading phase 1-4 clinical trials and supporting Investigator-initiated trials.
- Proven success managing clinical studies within timeline and budget.
- Strong interpersonal skills to interact with investigators and internal specialized teams.
- In-depth knowledge of PC operating systems and Microsoft Office suite (Word, Excel, PowerPoint, Project).
- Experience with CTM systems and EDC systems such as eClinical, Medidata RAVE, or InForm.
- Experience with Pharmacovigilance databases like ARGUS.
- Ability to travel up to 20% of the time.
Responsibilities
- Oversee clinical trial agreements, budgets, expenditures, and payments for clinical studies.
- Ensure timely execution of clinical research programs from conception through final study report.
- Supervise external contract organizations responsible for site monitoring, data management, biostatistics, and medical writing.
- Maintain oversight of study center conduct, including site selection, startup, and adherence to GCP and protocols.
- Lead the preparation and management of clinical study protocols, amendments, and key regulatory documents.
- Interface with Chief Medical Officer and cross-functional teams including Data Management, Drug Safety, and Regulatory Affairs.
- Supervise and mentor Clinical Operations team members, including performance management.
- Represent the company at external meetings and scientific congresses.
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