Vice President, Clinical Development & Strategy

Krystal Biotech; Pittsburgh (Allegheny County); On-site; USD 300,000 - 420,000; Full time

Job summary

Krystal Biotech, Inc. seeks a Vice President of Clinical Development to lead multiple therapeutic programs from clinic through product approval. You will influence clinical strategy, drive trials, and coordinate with cross-functional teams to meet milestones in a fast-paced environment.

The role centers on Phase 1–3 and post-approval activities, with responsibilities spanning data generation, regulatory interactions, and publication planning from Krystal's Pittsburgh headquarters.

Qualifications

• MD with biopharmaceutical industry experience and translational medicine experience.
• 10+ years in clinical development and ability to design and manage trials.
• Proven track record with FDA/EMA regulations and GCP.
• Experience in IND submissions and BLA/NDA filings.

Responsibilities

• Lead clinical development programs from late preclinical to registration and post-approval commitments.
• Collaborate with Clinical Operations and vendors to execute trials and studies.
• Prepare/review data listings, summaries, and development plans; ensure medical monitoring.
• Interface with regulatory agencies for IND/Pre-IND/BLA-related submissions and responses.
• Engage with academic institutions and thought leaders to guide study design and interpretation.
• Provide publications strategy and presentations for conferences and investigator meetings.
• Ensure adherence to regulatory requirements and industry standards.

Skills

Leadership

Regulatory knowledge

Cross-functional collaboration

Communication skills

Clinical development strategy

Analytical thinking

Team-building

Project management

Education

MD

Job description

Krystal Biotech, Inc. seeks a Vice President of Clinical Development to lead multiple therapeutic programs from clinic through product approval. You will influence clinical strategy, drive trials, and coordinate with cross-functional teams to meet milestones in a fast-paced environment.

The role centers on Phase 1–3 and post-approval activities, with responsibilities spanning data generation, regulatory interactions, and publication planning from Krystal's Pittsburgh headquarters.