Clinical Scientist

About the role

Krystal Biotech, Inc. is seeking a highly motivated Clinical Scientist to join our dynamic team. This role requires a strong background in clinical, scientific, and technical disciplines to support the development and execution of clinical 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
• Parsners 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
• Supports and contributes 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
• Supports the preparation, review, and submission of clinical publications

Requirements

• 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

Qualifications

• Must be able to pass a background check
• Must be able to pass a drug test

Skills

• Strong scientific and clinical research skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Strong attention to detail and organizational skills

Benefits

Krystal Biotech, Inc. offers a competitive benefits package including:

• Health insurance
• Retirement savings plan
• Flexible work schedule
• Professional development opportunities
• Employee wellness programs

Pay

The salary range for this position is $80,000 - $120,000 annually.

Schedule

This is a full-time position with flexible scheduling to accommodate clinical trial requirements.