Clinical Scientist, Gene Therapy Trials & Protocols

Krystal Biotech, Inc.; Pittsburgh (Allegheny County); On-site; USD 110,000 - 150,000; Full time

Job summary

Krystal Biotech, Inc. seeks a Clinical Scientist to unite clinical, scientific, and technical disciplines for protocol development, study execution, and data interpretation.

The role delivers clinical science outputs from Krystal’s trials and collaborates with the clinical team to support trial development and execution. Key duties include informing study design, safety monitoring, data quality reviews, and preparation of clinical study reports, regulatory submissions, and publications.

Qualifications

• Advanced scientific degree required; preferably a PhD in science or health-related field.
• 3+ years of drug development experience; or equivalent clinical research experience at CRO or academic institution
• Prior project team leadership experience preferred
• Must be able to travel domestically up to once a month and internationally as needed
• Ability to work onsite in Pittsburgh is highly preferred. Non-local candidates with direct industry experience and doctorate-level degree may be considered.
• Proficient at clinical data review including query generation and management
• Strong understanding of Good Clinical Practices
• Ophthalmology experience a plus, but not required
• Ability to work independently
• Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology
• Experience in monitoring and/or coordinating clinical trials required
• Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions
• Ability to interact with all levels of staff to coordinate/execute study activities
• Ability to handle several priorities within multiple, complex trials

Responsibilities

• Provides scientific expertise to inform clinical study design and analysis plans
• Drives protocol development, content, and quality review
• Ensures study plans and related documentation are accurate and complete
• Partners with data management to develop case report forms and data review plans
• Reviews patient level and cumulative data per the data review plan and coordinates with others for study level review
• Reviews and adjudicates protocol deviations
• Answers specific site protocol questions as needed and may provide issue resolution if medically qualified
• Participates in protocol training for Site Initiation Visits and Investigator Meetings, including training of study vendors and CRO staff
• Identifies scientific quality issues to discuss with investigators and study sites so that corrective actions may be instituted
• Assists in the preparation of clinical content for regulatory submissions/documents
• Support and contribute to requests for information from health authorities
• Assists Clinical Operations in assuring adherence to Good Clinical Practice, investigator integrity, and compliance with all study procedures
• Participates in interpretation and presentation of study results, including authoring of Clinical Study Reports
• Support the preparation, review, and submission of clinical publications
• Other duties as assigned

Skills

Clinical data review

Written and verbal communication

Team collaboration

Independent work

Travel readiness

Education

PhD in science or health-related field

Advanced scientific degree

Tools

Data management software

Job description

Krystal Biotech, Inc. seeks a Clinical Scientist to unite clinical, scientific, and technical disciplines for protocol development, study execution, and data interpretation.

The role delivers clinical science outputs from Krystal’s trials and collaborates with the clinical team to support trial development and execution. Key duties include informing study design, safety monitoring, data quality reviews, and preparation of clinical study reports, regulatory submissions, and publications.