FTI Consulting
DirectorFull-timeHybridSydney NSW, AustraliaProfessional servicesPosted 2 weeks ago
About the job
This job is about building a high-caliber drug development consulting group that partners with biotech and pharma sponsors. The impact of this role is significant, as it involves leading client engagements and crafting strategies that shape the future of drug development. The team thrives on collaboration, passion, and a commitment to excellence, ensuring that every member feels valued and supported.
You'll be responsible for
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Leading client engagements
Define global development strategy from preclinical through approval and lifecycle management.📝
Drafting regulatory strategy documents
Create and defend documents such as briefing packages, IND/CTA/MAA/NDAs, and responses to authorities.📈
Designing clinical development programs
Align statistical, PK/PD, safety, and operational considerations in clinical protocols.What we're looking for
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Advanced degree in life sciences
Possession of an MD, PharmD, or PhD for drug development expertise.View fit
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12+ years of drug development experience
Demonstrated experience across multiple therapeutic areas in drug development.View fit
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Global regulatory strategy expertise
Proven success directing regulatory interactions and submissions globally.View fit
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