VP, Clinical Development & Strategy

BioPhase; San Diego (CA); On-site; USD 250,000 - 360,000; Full time

Job summary

BioPhase seeks a VP, Clinical Development to lead the planning and execution of the lead asset's clinical development program, guiding from research to clinic and coordinating with CMO and executive teams on strategy.

The role directs cross-functional clinical research activities across operations, biometrics, data management, and safety, contributing to regulatory submissions and lifecycle planning for the pipeline.

Qualifications

• MD required.
• Board certification in gastroenterology preferred; related areas also considered.
• Minimum of 8 years in biotech/pharma, incl. 3–5 years in clinical development leadership at Senior Director/VP level.

Responsibilities

• Design and lead early- to late-phase clinical trials for the lead asset.
• Oversee CROs and vendor management for clinical operations.
• Develop and nurture relationships with external KOLs and advisors.
• Monitor program status and provide regular updates to leadership.
• Author/review regulatory documents (INDs, BLAs/NDAs, CSRs).
• Prepare for FDA/EMA meetings and briefing packages; strategize agency responses.

Skills

Interpersonal skills

Presentation skills

Strategic thinking

Cross-functional collaboration

PowerPoint proficiency

Travel up to 25%

Education

MD required

Gastroenterology board certification preferred

Fellowship/training in related area considered

Tools

Excel

Word

PowerPoint

Job description

BioPhase seeks a VP, Clinical Development to lead the planning and execution of the lead asset's clinical development program, guiding from research to clinic and coordinating with CMO and executive teams on strategy.

The role directs cross-functional clinical research activities across operations, biometrics, data management, and safety, contributing to regulatory submissions and lifecycle planning for the pipeline.