Chief Clinical Development & Strategy, Early Programs

Qpex Biopharma, Inc.; San Diego (CA); Hybrid; USD 380,000 - 460,000; Full time

Job summary

Qpex Biopharma, Inc. is seeking a Senior Vice President Clinical Development to provide strategic and scientific leadership for early development programs, oversee trial direction and data interpretation from first‑in‑human through early proof‑of‑concept.

This role includes hands‑on FDA regulatory interactions and alignment of clinical strategy to regulatory expectations. The position partners with executive leadership and collaborates with Regulatory, Biometrics and Medical Affairs teams across

Qualifications

• M.D. and a minimum of 15 years’ experience in biotech/pharma clinical development.
• Experience interacting with regulatory agencies and investors/Board of Directors.
• Therapeutic focus in infectious disease or pulmonary medicine is a plus.

Responsibilities

• Lead transition of compounds from research to clinical development (Phase 1–2a).
• Act as medical monitor for early phase trials and finalize regulatory study reports.
• Provide clinical development leadership for late-stage trials in collaboration with Shionogi.
• Interface with Research, Nonclinical, Regulatory, and Biostatistics teams to align strategy.
• Represent Clinical Development to Board, partners, and government agencies.
• Develop regulatory strategy with Regulatory Affairs and author submissions.
• Direct staffing, performance reviews, and department management.
• Ensure compliance with FDA, GCP, and ICH guidelines.

Skills

Clinical development leadership

FDA regulations

Regulatory submissions

Cross-functional leadership

Executive communication

Education

MD

PhD in a relevant field

Job description

Qpex Biopharma, Inc. is seeking a Senior Vice President Clinical Development to provide strategic and scientific leadership for early development programs, oversee trial direction and data interpretation from first‑in‑human through early proof‑of‑concept.

This role includes hands‑on FDA regulatory interactions and alignment of clinical strategy to regulatory expectations. The position partners with executive leadership and collaborates with Regulatory, Biometrics and Medical Affairs teams across