Job Title

Secure a Gap Analysis specialist to establish a focused management system for 15 ADC pipelines / Senior Project Manager

Responsibilities

[ Pipeline Gap Analysis ]

• Regularly assess the completeness of IND/clinical entry data packages (CMC, nonclinical, toxicology) for assigned ADC assets
• Document missing data, weak evidence, and items requiring supplementation from a regulatory submission perspective

[ Clinical Path Definition & Tracking ]

• Contribute strategic input to clinical strategy development, including target indication, patient population, and FIH dose escalation design
• Pre-screen Research team experimental plans for regulatory compliance to minimize rework

[ Regulatory Strategy Support ]

• Monitor and disseminate updates on ADC-related guidelines from FDA, EMA, and MFDS
• Analyze competitor ADC IND/clinical cases and provide strategic reference materials

[ Project Management & Reporting ]

• Develop and maintain project plans, milestone trackers, and risk registers for assigned assets
• Lead CRO/partner progress meetings; escalate issues and propose resolution plans
• Prepare monthly/quarterly pipeline review materials to support PM Lead and executive reporting
• Mentor junior PMs and contribute to standardization of Gap Analysis frameworks and reporting templates

Qualifications

• Master's degree or above in Life Sciences, Pharmacy, Biomedical Engineering, or related field
• 5+ years of hands-on experience across the clinical development process (Pre-IND through Phase I/II)
• Experience managing external partners (CRO/CDMO) and working within multi-functional teams
• Proficiency in reading and reviewing regulatory documents in English (IND, Investigator's Brochure, etc.)

Requirements

• Practical understanding of CMC, nonclinical (toxicology, PK/PD), and clinical data package requirements
• Ability to independently assess strengths and weaknesses of an IND package from a regulatory perspective
• Strong communication skills to translate complex scientific and regulatory issues into structured insights for

Benefits & Application QR code in attached file