Director Clinical Development

Our client is a clinical-stage biotechnology company developing innovative therapies across multiple therapeutic areas, including cardiometabolic and hepatology indications. They are seeking a Director, Clinical Development to provide clinical leadership across programs from early development through regulatory approval. Position Summary The Director, Clinical Development will lead the design, planning, and execution of clinical programs while ensuring scientific integrity and medical oversight across all phases of development.

This individual will collaborate cross-functionally with Clinical Operations, Regulatory, Pharmacovigilance, Biostatistics, Medical Affairs, and other key stakeholders to drive program strategy and execution. Key Responsibilities Provide clinical leadership for assigned development programs Design and oversee clinical studies across all phases of development Serve as medical monitor and subject matter expert as needed Collaborate cross-functionally to ensure aligned strategy and execution Review and interpret clinical data and contribute to study reports and publications Support regulatory interactions and submissions (e.g., IND, NDA/BLA) Present data at scientific meetings and regulatory forums Build relationships with investigators, KOLs, and external partners Support clinical strategy, budgeting, and program planning Ensure compliance with regulatory requirements and GCP standards Qualifications MD required (Board certification preferred) 5+ years of industry or combined academic/industry experience Experience across all phases of clinical development Strong cross-functional leadership and communication skills Knowledge of FDA regulations, ICH/GCP, and clinical trial operations Experience in cardiometabolic and/or hepatology preferred Key Skills Strong scientific and clinical background Strategic thinking and problem-solving abilities Project leadership and stakeholder management Excellent communication and presentation skills Familiarity with clinical pharmacology, biostatistics, and regulatory requirements #J-18808-Ljbffr