VP, Clinical Development – Rare Diseases

Krystal Biotech, Inc.; Pittsburgh (Allegheny County); On-site; USD 250,000 - 350,000; Full time

Job summary

Krystal Biotech, Inc. is seeking a Vice President of Clinical Development to lead parallel development programs from the clinic through product approval.

The VP will be a core member of the clinical team, advancing programs from early development to proof-of-concept and commercialization in a fast-paced, cross-functional environment. Based at Krystal’s headquarters in Pittsburgh, PA, this role partners with Clinical Operations, Regulatory, Medical Affairs, and external collaborators to deliver

Qualifications

• Ten or more years in clinical development; leadership experience.
• Strong knowledge of FDA/EMA regulations and GCP.

Responsibilities

• Lead clinical development programs from late preclinical to post-approval commitments.
• Collaborate with Clinical Operations and vendors to execute trials and data collection.
• Prepare and review clinical/regulatory/safety documents and study reports.
• Interact with regulatory agencies and author/review INDs, BLAs, and MAAs.
• Engage with academic institutions and key opinion leaders; oversee publications and presentations.
• Support patient recruitment strategies with clinical sites.
• Develop manuscripts and publication materials; contribute to conference presentations.
• Represent Krystal Biotech externally through publications and scientific meetings.
• Assist with business development and pipeline activities.
• Ensure adherence to regulatory requirements and industry standards.

Job description

Krystal Biotech, Inc. is seeking a Vice President of Clinical Development to lead parallel development programs from the clinic through product approval.

The VP will be a core member of the clinical team, advancing programs from early development to proof-of-concept and commercialization in a fast-paced, cross-functional environment. Based at Krystal’s headquarters in Pittsburgh, PA, this role partners with Clinical Operations, Regulatory, Medical Affairs, and external collaborators to deliver