SVP, Head of Global Early Clinical Development

Role Summary

SVP, Head of Global Early Clinical Development. Leads strategic and operational execution of early-phase clinical programs (Phase 1 and early Phase 2a), ensuring scientific rigor, regulatory compliance, and alignment with the broader R&D strategy. Focuses on translating preclinical insights into clinical hypotheses and guiding development across multiple therapeutic areas. Based in West Chester, PA with potential flexibility to Parsippany, NJ or remote arrangements.

Responsibilities

• Strategic Leadership: Provide leadership as a critical member of Global R&D Leadership Team and lead all programs from first-in-human to proof-of-principle (POC). Define and execute the global strategy for early clinical development, integrating translational medicine, clinical pharmacology, and biomarker analytics. Contribute to portfolio decisions and cross-functional alignment.
• Clinical Program Oversight: Oversee the design and execution of Phase 1 studies in healthy volunteers and patients, including dose selection and PK/PD modeling. Provide leadership for all POC studies and their transition to full development. Ensure integration of AI-driven analytics and computational biology to enhance trial design and data interpretation.
• Cross-Functional Collaboration: Lead matrix teams across TPM, QPB, and AI/DS. Collaborate with Disease Area Heads and Global Program Leadership to ensure seamless transition from early to late-stage development.
• Talent & Organizational Development: Build and mentor a high-performing team of clinical scientists, physicians, and data analysts. Drive organizational agility and innovation through structural simplification and capability enhancement.
• Governance & Compliance: Ensure adherence to GCP, regulatory requirements, and internal quality standards. Represent the ECD function in governance forums and external scientific engagements.

Qualifications

• MD or MD/PhD
• 10+ years of experience in clinical development, with a strong focus on early-phase trials
• Proven leadership in global, matrixed organizations
• Deep expertise in translational medicine, clinical pharmacology, and biomarker strategy
• Familiarity with AI/ML applications in clinical research is highly desirable

Skills

• Strategic thinking and scientific acumen
• Operational excellence and project execution
• Cross-functional leadership and stakeholder engagement
• Innovation mindset and adaptability to change
• Strong communication and decision-making skills

Education

• MD or MD/PhD (as listed in Qualifications)