Strong Project Management
Regulatory submission experience
Participate on a cross functional team focused on US regulatory submissions (FDA).
* Previous Pfizer experience is preferred; Pharmaceutical/biotech experience mandatory.
Familiarity with U.S. NDA processes required
Provides Financial Oversight
Forecasts and manages high level clinical trial budget. Oversees the study risk planning process (e.g. IQMP)
Works proactively with AP/CRO
Supports Practical Clinical Trial Design
o Partners with Clinician and other team members and supporting functional lines to provide operational expertise and insight to inform protocol design.
o Initiates and ensures a Protocol Operational Feasibility and Budget assessment is performed by seeking input from other lines within Development Operations and at the Alliance Partner/Vendor as needed.
o Facilitates early engagement of Alliance Partners/Vendors when needed.
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