Senior Vice President, Clinical Development

Skills

About the Role

You will lead clinical strategy, design and execution for oncology and rare disease programs, reporting to the CMO. You will lead clinical scientists and medical directors, partner with regulatory, clinical operations, biostatistics and translational medicine, embed AI-enabled trial design, and represent the company externally.

Requirements

• 15+ years of clinical development experience in oncology, rare disease, immunology or precision medicine
• MD or MD/PhD strongly preferred
• Experience leading Phase 1 and Phase 1/2 trials and accountability for IND filings
• Track record of cross-functional leadership and managing teams
• Experience with TechBio or AI-enabled drug development environments
• Direct experience engaging with FDA and other regulators
• Experience managing timelines and budgets
• Strong scientific acumen in small molecule development, oncology or rare disease
• Exceptional communication and leadership skills

Responsibilities

• Lead clinical strategy, design and execution of oncology and rare disease programs
• Define clinical development strategy including study design, endpoints and regulatory pathway
• Lead design, initiation and oversight of early and late-stage clinical trials
• Embed AI-assisted protocol design and digital tools with the ClinTech organization
• Lead and mentor medical directors and clinical scientists
• Lead FDA and international agency interactions and guide IND strategy
• Ensure trials are delivered on time and on budget with Clinical Operations
• Develop biomarker strategies and adaptive trial designs
• Oversee clinical safety monitoring and Independent Data Monitoring Committee interactions
• Contribute to portfolio prioritization and go/no-go decisions
• Represent the company at conferences, advisory boards and KOL engagements
• Support business development due diligence and in-licensing evaluations
• Contribute clinical content for investor communications