Director Clinical Science
New
I
IovanceBiotechnology
RemoteFull-TimeDirector
Salary175,000 - 225,000 USD per year
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Job Details
- Experience
- 7+ years’ clinical trial experience; 2+ years’ experience in clinical science
- Required Skills
- Project ManagementData AnalysisGCP
Requirements
- Advanced Clinical/Science Degree (e.g., PhD, PharmD, MD) preferred.
- 7+ years of clinical trial experience with relevant therapeutic area expertise.
- 2+ years of specific experience in clinical science.
- In-depth understanding of Phase 1 through 4 drug development.
- Experience authoring experimental protocols and interpreting study results.
- Mandatory experience in data listing review.
- Knowledge of GCP, ICH, FDA, and EMEA guidelines.
- Strong analytical skills with experience in ISS/ISE and competitor data analysis.
- Excellent project management and interpersonal communication skills.
- Ability to travel approximately 25% of the time.
- Proficiency in Microsoft Office Suite (Word, PowerPoint, Excel).
Responsibilities
- Participate in Clinical Development Core Teams (CSCT) and Clinical Sub-Teams (CST).
- Support the development of clinical science strategies, Lifecycle Plans (LCPs), and commercialization plans.
- Provide clinical science support for assigned studies, including literature searches and input on study designs.
- Design clinical protocols, manuals, and case report forms (CRFs) in collaboration with cross-functional partners.
- Write and review clinical documentation such as investigator brochures, safety monitoring plans, and protocol summaries.
- Analyze clinical study data and review reporting documents with internal stakeholders.
- Coordinate and draft content for scientific meetings, posters, and publications.
- Support regulatory filings and participate in health authority meetings.
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