Chief Clinical Development & Regulatory Strategy

Infectious Disease Association of California; San Diego, Northern (CA, KY); Hybrid; USD 380,000 - 460,000; Full time

Job summary

Qpex Biopharma, Inc. in San Diego seeks an Executive to lead Clinical Development, shaping early programs from first-in-human to early proof-of-concept with regulatory alignment across FDA guidelines.

The role requires hands‑on leadership, strong communication with the Board and stakeholders, and collaboration across Regulatory, Biometrics, Medical Affairs, and Commercial teams within the Shionogi group. Remote work is limited to rare circumstances.

Qualifications

• MD with minimum 15 years in biotech/pharma managing clinical drug development, including leadership responsibilities.
• Experience interacting with regulatory agencies and investors/Board of Directors.
• Therapeutic focus in Infectious Disease or Pulmonary Medicine; PhD a plus.

Responsibilities

• Lead transition of portfolio compounds from research into clinical development (Phase 1-2a).
• Act as medical monitor for early phase studies and finalize CSR for regulatory submission.
• Provide Clinical Development leadership for late‑stage trials in collaboration with cross‑functional teams.

Skills

Clinical development leadership

FDA regulatory interactions

Cross-functional leadership

Data interpretation

Medical communication

Education

MD degree

PhD in a relevant field

Tools

Clinical trial management systems

Regulatory submission tools

Job description

Qpex Biopharma, Inc. in San Diego seeks an Executive to lead Clinical Development, shaping early programs from first-in-human to early proof-of-concept with regulatory alignment across FDA guidelines.

The role requires hands‑on leadership, strong communication with the Board and stakeholders, and collaboration across Regulatory, Biometrics, Medical Affairs, and Commercial teams within the Shionogi group. Remote work is limited to rare circumstances.