Chief Medical Officer

Clinical Strategy & LeadershipLead 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)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