Clinical Strategy & Leadership
Lead the overall clinical development strategy across I&I pipeline
• Translate preclinical and translational data into clear clinical development plans
• Design clinical development roadmaps from early-phase through proof-of-concept • Provide expert input on indication prioritization, endpoints, biomarkers, and differentiation strategy Trial Design & Execution Oversight
• Lead protocol strategy for Phase 1–2 trials (design, endpoints, patient population, safety monitoring)
• Partner with CROs and vendors to ensure high-quality study execution
• Participate in investigator meetings, KOL engagement, and advisory boards
• Support DSMB interactions and clinical risk mitigation strategies Regulatory & Cross-Functional Collaboration
• Contribute to regulatory strategy and preparation for FDA/EMA interactions (INDs, briefing packages, meetings)
• Collaborate with regulatory, CMC, nonclinical, and translational teams to ensure integrated development plans
• Review and contribute to clinical sections of regulatory documents External Representation
• Serve as a senior clinical voice with: o Investors and Board (as appropriate)
o Key opinion leaders o Strategic partners and collaborators Qualifications Required
• MD or DO with board certification
• 10–15+ years of experience in clinical development within biotech or pharma
• Demonstrated leadership of early- to mid-stage clinical programs (IND through Phase 2)
• Direct experience with clinical trial design and protocol authorship
• Track record of meaningful FDA or global regulatory agency interactions
• Experience working in small or emerging biotech environments
• Ability to operate both strategically and hands-on Preferred
• Prior experience in a CMO, VP, or Head of Clinical Development role
• Experience in asset strategy for partnering or fundraising environments
• Background working with outsourced models and CRO oversight
