Senior Clinical Scientist, Trials & Data Insight

Krystal Biotech; Pittsburgh (Allegheny County); On-site; USD 110,000 - 170,000; Full time

Job summary

Krystal Biotech, Inc. seeks a Clinical Scientist to integrate clinical, scientific, and technical disciplines for high-quality protocol development, trial execution, and data interpretation.

You will deliver clinical science deliverables, support protocol development and safety monitoring, review data quality, and prepare Clinical Study Reports. The role partners across clinical teams to meet internal and external needs.

Qualifications

• Advanced scientific degree required; PhD preferred.
• 3+ years of drug development or CRO/academic clinical research experience.
• Prior leadership experience on project teams is preferred.
• Willingness to travel domestically and internationally as needed.
• Onsite work in Pittsburgh highly preferred.

Responsibilities

• Provide scientific expertise to inform study design and analysis plans.
• Drive protocol development, content, and quality review.
• Ensure study plans and documentation are accurate and complete.
• Collaborate with data management to develop CRFs and data review plans.
• Review patient-level and cumulative data and coordinate study-level reviews.
• Review and adjudicate protocol deviations.
• Participate in site initiation training for investigators and CRO staff.
• Identify scientific issues and discuss corrective actions with investigators.
• Assist in preparing clinical content for regulatory submissions.
• Support information requests from health authorities.
• Ensure adherence to GCP and investigator integrity.
• Contribute to interpretation and presentation of study results and Clinical Study Reports.
• Support clinical publications and other duties as assigned.

Skills

Advanced scientific degree

Drug development experience

Project team leadership

Travel ability

Clinical data review

Good Clinical Practice

Independent work

Clinical research process knowledge

Monitoring/coordination of trials

Communication skills

Cross-functional coordination

Education

PhD in science or health-related field

Job description

Krystal Biotech, Inc. seeks a Clinical Scientist to integrate clinical, scientific, and technical disciplines for high-quality protocol development, trial execution, and data interpretation.

You will deliver clinical science deliverables, support protocol development and safety monitoring, review data quality, and prepare Clinical Study Reports. The role partners across clinical teams to meet internal and external needs.