The Opportunity
We are seeking a Vice President, Clinical Development to lead the clinical advancement of our rare renal disease portfolio. The client is a small venture-backed clinical stage start-up. This is a hands-on executive role for a physician-leader who will own clinical strategy from first-in-human through proof-of-concept and registrational planning. The VP of Clinical Development will be a core member of the leadership team, shaping program strategy, regulatory positioning, and external partnerships while building and scaling the clinical organization.
Key Responsibilities
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Own end-to-end clinical development strategy across one or more rare renal disease programs
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Define Phase I–III development plans, dose-finding strategies, endpoints, and go/no-go criteria
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Design and oversee all clinical trials from first-in-human through registrational planning
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Serve as the medical and scientific lead for ongoing studies, including safety review and data interpretation
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Lead clinical interactions with regulatory agencies (FDA, EMA), including INDs and end-of-Phase meetings
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Own the clinical components of regulatory submissions and briefing packages
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Ensure tight integration between clinical endpoints, biomarker strategy, and mechanism of action
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Partner closely with translational science, regulatory, biometrics, and clinical operations teams
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Oversee CROs, investigators, and global trial execution
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Represent the company with investigators, advisors, investors, and potential partners
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Build, lead, and scale the clinical development organization and operating model
Requirements
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MD (or equivalent) with training in nephrology, internal medicine, or a related specialty
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10+ years of experience in biotech or pharmaceutical clinical development
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Proven leadership of early- and mid-stage (Phase I–II) clinical programs
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Deep understanding of rare disease development, biomarker-driven trials, and regulatory strategy
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Prior experience advancing a program from first-in-human to proof-of-concept or later stages
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Experience in rare renal or immune-mediated kidney diseases (e.g., IgAN, FSGS, lupus nephritis, ADPKD, complement-mediated disorders) strongly preferred
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Background working in lean, VC-backed or portfolio-company environments
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Track record managing CROs, global trials, and cross-functional clinical teams
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