About Tessera Therapeutics
Tessera Therapeutics is an early-stage life sciences company pioneering Gene Writing™, a new biotechnology designed to offer scientists and doctors the…. Backed by SoftBank VF.
About the role
You are an individual with excellent team management abilities, who will lead the cross-functional Clinical Study Team and be responsible for overall clinical study delivery. You will be the primary point of contact for leadership and oversight of the assigned study(ies).
What they're looking for
- Experience in managing global clinical operations for first-in-human to Phase 3 Programs from start-up to close out, including managing clinical CRO and other vendors, budgets and timelines
- In depth knowledge of ICH/GCP guidelines and working knowledge of regulatory guidelines/directives
- Proficiency in trial management systems, IVRS/IWRS, eTMF, EDC, SmartSheets and Microsoft applications including Project, PowerPoint, Word and Excel
- FDA and other regulatory inspection experience is a plus
- Current rare disease experience and/or gene therapy experience is highly preferred
- Effective project management skills, cross-functional team leadership and organizational skills
More about this role
- Bachelor’s degree in a relevant scientific or healthcare discipline, with 8+ years of clinical operations experience, including 4+ years as a clinical trial manager, leading cross-functional teams and accountable for planning and executing global clinical trials.
- Experience in managing global clinical operations for first-in-human to Phase 3 Programs from start-up to close out, including managing clinical CRO and other vendors, budgets and timelines
- In depth knowledge of ICH/GCP guidelines and working knowledge of regulatory guidelines/directives.
- Proficiency in trial management systems, IVRS/IWRS, eTMF, EDC, SmartSheets and Microsoft applications including Project, PowerPoint, Word and Excel
- FDA and other regulatory inspection experience is a plus
- Current rare disease experience and/or gene therapy experience is highly preferred
- Effective project management skills, cross-functional team leadership and organizational skills
- Ability to thrive in a fast-paced environment with a demonstrated ability to prioritize and manage multiple competing tasks, and flexibility to adapt to changing program needs
- Actively engage in day-to-day clinical trial management activities...
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