BENEFITS n Completed Chemistry and Manufacturing Controls (CMC) and preclinical work and IND submitted within challenging investor-driven timelines n Managed a complex program with numerous vendors, client representatives and external consultants, to ensure program remained on track n Supported the alignment of the operational team and client management enabling the senior management to focus on investor activities following review of IND, FDA allowed initiation of FIH study with patient arm n Exceeded client expectations and began additional program for second generation compound NEED n US biotech company required integrated program management including IND-enabling preclinical studies and writing of First-In-Human study n Support for the organiz

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