Clinical Scientist

at  Krystal Biotech

About Krystal Bio: At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs.
Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient’s end-to-end experience.
Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK®, for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology.
Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values.

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. They will be responsible for clinical science deliverables from Krystal’s clinical trials. The Clinical Scientist is a key member of the team and partners closely with other clinical team members, applying technical and scientific excellence to support the development and execution of clinical trials to meet the needs of internal and external customers. Clinical Scientist responsibilities impact key elements of the study lifecycle including protocol development, safety monitoring, data quality review, patient narratives, and preparation of Clinical Study Reports. Ideally, this role will be based in Pittsburgh, PA.

Primary 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

Experience and Skills Desired:

• PharmD or 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, PA Headquarters, is significantly preferred
• 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

Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employers. 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 Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and 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.
5DVzrBEdu

• 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 assigne