Clinical Scientist

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

Job Description Summary:

Krystal Biotech, Inc is seeking a highly motivated Clinical Scientist to be responsible for bringing together clinical, scientific, and technical disciplines to ensure high quality protocol development, study execution, and data interpretation. The Clinical Scientist will deliver clinical science deliverables from Krystal’s clinical trials, support protocol development, safety monitoring, data quality review, and the preparation of Clinical Study Reports. The role partners closely with other clinical team members, applying technical and scientific expertise to support the development and execution of clinical trials to meet the needs of internal and external customers.

Primary Responsibilities:

• Provide scientific expertise to inform clinical study design and analysis plans
• Drive protocol development, content, and quality review
• Ensure study plans and related documentation are accurate and complete
• Partner with data management to develop case report forms and data review plans
• Review patient-level and cumulative data per the data review plan and coordinate with others for study-level review
• Review and adjudicate protocol deviations
• Answer specific site protocol questions as needed and provide issue resolution if medically qualified
• Participate in protocol training for Site Initiation Visits and Investigator Meetings, including training of study vendors and CRO staff
• Identify scientific quality issues to discuss with investigators and study sites so that corrective actions can be instituted
• Assist in the preparation of clinical content for regulatory submissions/documents
• Support and contribute to requests for information from health authorities
• Assist Clinical Operations in ensuring adherence to Good Clinical Practice, investigator integrity, and compliance with all study procedures
• Participate in interpretation and presentation of study results, including authoring of Clinical Study Reports
• Support the preparation, review, and submission of clinical publications
• Perform other duties as assigned

Experience and Skills Desired:

• Advanced scientific degree required; preferably a PhD in science or a health‑related field
• 3+ years of drug development experience; or equivalent clinical research experience at a 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 Practice
• Ophthalmology experience is a plus, but not required
• Ability to work independently
• Strong knowledge of the 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

Krystal Biotech, Inc. is an Equal Employment Opportunity and affirmative action employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this website or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter or agency resumes. Krystal Biotech, Inc. will not pay fees to any third‑party agency or company that does not have a signed agreement with Krystal Biotech, Inc.