Executive VP, Clinical Development & Regulatory Strategy

Qpex Biopharma Inc in; San Diego (CA); On-site; USD 380,000 - 460,000; Full time

Job summary

Qpex Biopharma Inc seeks a Senior Vice President, Clinical Development to lead early development strategies, oversee trial design and data interpretation from first-in-human to early proof-of-concept, and ensure regulatory alignment with FDA expectations.

This executive role partners with Shionogi entities and internal teams to drive development programs, manage resources, and provide strategic leadership while maintaining high scientific standards and hands-on involvement; San Diego office

Qualifications

• MD with 15+ years in biotech/pharma clinical drug development.
• 5+ years in a leadership role with regulatory interactions with FDA.
• Experience in infectious disease or pulmonary medicine is a plus.
• Ability to lead multiple early clinical programs and oversee risk, patient safety, and cross-functional collaboration.
• Excellent communication and executive presence; willing to be hands-on and work in San Diego.

Responsibilities

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

Skills

MD degree

Clinical development leadership

Regulatory interaction

People management

Communication skills

FDA & ICH knowledge

Education

M.D. degree

Job description

Qpex Biopharma Inc seeks a Senior Vice President, Clinical Development to lead early development strategies, oversee trial design and data interpretation from first-in-human to early proof-of-concept, and ensure regulatory alignment with FDA expectations.

This executive role partners with Shionogi entities and internal teams to drive development programs, manage resources, and provide strategic leadership while maintaining high scientific standards and hands-on involvement; San Diego office