Clinical Scientist

Thanks for visiting our Career Page. Please review and apply to our positions which match your qualifications.Krystal Biotech, a Pittsburgh-based company founded in 2016, has quickly emerged as a global leader in gene therapy.

In May 2023, Krystal Bio received FDA approval for the first-ever redosable gene therapy, VYJUVEK™, for the treatment of Dystrophic Epidermolysis Bullosa. Krystal continues to leverage their proprietary platform to develop new treatments throughout its clinical pipeline.

Additionally, the company has developed innovative commercial- and clinical-stage manufacturing processes, deployed across two state-of-the-art GMP facilities.BenefitsWe make every effort to provide essential and desirable benefits that make each employee's life that much easier. In addition to benefits listed below, we also offer competitive compensation that rewards you for your contributions toward achieving company goals.Benefits include:Equity / Stock OptionsMedical and Prescription Drug CoverageDental and Vision InsuranceShort and Long-Term Disability Insurance401(k) With Company MatchPaid HolidaysPaid Time OffFlexible Spending Accounts (Health Care & Dependent Care)Employee Assistance Program & Benefits Concierge AppAD&D and Life InsuranceWellness Rewards ProgramClinical ScientistPittsburgh, PAFull TimeClinical DevelopmentExperiencedShareAbout 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.Primary Responsibilities:Provides scientific expertise to inform clinical study design and analysis plansDrives protocol development, content, and quality reviewEnsures study plans and related documentation are accurate and completePartners with data management to develop case report forms and data review plansReviews patient level and cumulative data per the data review plan and coordinates with others for study level reviewReviews and adjudicates protocol deviationsAnswers specific site protocol questions as needed and may provide issue resolution if medically qualifiedParticipates in protocol training for Site Initiation Visits and Investigator Meetings, including training of study vendors and CRO staffIdentifies scientific quality issues to discuss with investigators and study sites so that corrective actions may be institutedAssists in the preparation of clinical content for regulatory submissions/documentsSupport and contribute to requests for information from health authoritiesAssists Clinical Operations in assuring adherence to Good Clinical Practice, investigator integrity, and compliance with all study proceduresParticipates in interpretation and presentation of study results, including authoring of Clinical Study ReportsSupport the preparation, review, and submission of clinical publicationsOther duties as assignedExperience and Skills Desired:Advanced scientific degree required; preferably a PhD in science or health-related field3+ years of drug development experience; or equivalent clinical research experience at CRO or academic institutionPrior project team leadership experience preferredMust be able to travel domestically up to once a month and internationally as neededAbility to work onsite in Pittsburgh ishighlypreferred. Non-local candidates with direct industry experience and doctorate-level degree may be considered.Proficient at clinical data review including query generation and managementStrong understanding of Good Clinical PracticesOphthalmology experience a plus, but not requiredAbility to work independentlyStrong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminologyExperience in monitoring and/or coordinating clinical trials requiredExcellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutionsAbility to interact with all levels of staff to coordinate/execute study activitiesAbility to handle several priorities within multiple, complex trialsKrystal Biotech, Inc. is anEqual 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.ShareApplyApply for this positionRequired*First Name*Last Name*Email Address*Phone*AddressResume*We've received your resume. Clickhereto update it.Attach resumeorPaste resumeAttach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) orPaste resumePaste your resume here orAttach resume fileCover LetterAre you willing to relocate?No answerYesNoWhat's your citizenship / employment eligibility?No answerI am a U.S.

Citizen/Permanent ResidentNon-citizen allowed to work for any employerNon-citizen allowed to work for current employerNon-citizen seeking work authorizationI am a Canadian Citizen/Permanent ResidentOtherDesired salaryEarliest start date?Do you have a doctorate-level (PharmD or PhD) degree?*-- No answer --YesNoDo you have 2+ years of recent drug development or clinical research experience?*-- No answer --YesNoDo you live in Pittsburgh, or are you willing to relocate to Pittsburgh and work in Krystal's HQ 5 days/week?*-- No answer --YesNoThe following questions are entirely optional.To comply with government Equal Employment Opportunity and/or Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law.

Your voluntary cooperation would be appreciated.Learn more.GenderDecline to answerFemaleMaleRace/EthnicityDecline to answerHispanic or LatinoWhite, not Hispanic or LatinoBlack or African-American, not Hispanic or LatinoAsian, not Hispanic or LatinoNative Hawaiian or Other Pacific Islander, not Hispanic or LatinoAmerican Indian or Alaskan Native, not Hispanic or LatinoTwo or More Races, not Hispanic or LatinoMENA (Middle Eastern and North African)Human Check*Submit Application