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Jobs at Krystal Biotech, Inc. (Now Hiring) — 11 open

Krystal Biotech, Inc. logoKrystal Biotech, Inc.

Medical Director/Senior Medical Director (Clinical Development)

Pittsburgh, Pennsylvania, United States · On-site

Mid level$546M raised

Medical Director/Senior Medical Director (Clinical Development) About Krystal Bio: At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing…

Skills: Clinical Trial Management, Clinical Research, GCP Guidelines, Protocol Development, Regulatory Compliance

Krystal Biotech, Inc. logoKrystal Biotech, Inc.

Head of Clinical Development (Vice President)

Pittsburgh, Pennsylvania, United States · On-site

Senior+$546M raised

Head of Clinical Development (Vice President) About Krystal Bio: At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercializ…

Skills: Clinical Development Strategy, Clinical Trial Design, Regulatory Affairs, Medical Monitoring, Drug Safety Surveillance

Krystal Biotech, Inc. logoKrystal Biotech, Inc.

Gene Therapy Consultant/Medical Representative, Japan

Tokyo, Japan · On-site

Senior$546M raised

About Krystal Biotech: 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 diseas…

Skills: Pharmaceutical Sales, Rare Disease Sales, KOL Relationship Management, Account Planning, Medical Education

Krystal Biotech, Inc. logoKrystal Biotech, Inc.

Bilingual Patient Access Liaison

Houston, Texas, United States · Remote OK

Senior$546M raised

The geography covers TX, MO, KS, AR, and OK. The ideal candidate location would be Houston, Dallas, Austin or San Antonio. Bilingual Patient Access Liaison About Krystal Bio: At Krystal Biotech, we bring together the bri…

Skills: Bilingual English and Spanish, Patient Access, Reimbursement, Rare Disease Experience, Case Management

Krystal Biotech, Inc. logoKrystal Biotech, Inc.

Clinical Scientist

Pittsburgh, Pennsylvania, United States · On-site

Mid level$546M raised

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 w…

Skills: Protocol Development, Clinical Data Review, Good Clinical Practice, Clinical Study Reports, Safety Monitoring

Krystal Biotech, Inc. logoKrystal Biotech, Inc.

Associate Rare Disease Sales Representative

Providence, Rhode Island, United States · Remote OK

Senior$546M raised

Position will cover a broad region along the US East Coast, across several multi-state territories. About Krystal Bio: At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the d…

Skills: Pharmaceutical Sales, Territory Management, Market Development, Relationship Building, Strategic Thinking

Krystal Biotech, Inc. logoKrystal Biotech, Inc.

Quality Control Analyst I

Pittsburgh, Pennsylvania, United States · On-site

Mid level$546M raised

Quality Control Analyst / Specialist I About Krystal Bio: At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization o…

Skills: Mammalian Cell Culture, Plaque Titer, ELISA, qPCR, Southern Blot

Krystal Biotech, Inc. logoKrystal Biotech, Inc.

Quality Control Laboratory Analyst (Raw Materials)

Pittsburgh, Pennsylvania, United States · On-site

Mid level$546M raised

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 w…

Skills: cGMP Material Inspection, Analytical Data Review, Laboratory Investigations, SOP Documentation, USP Quality Standards

Krystal Biotech, Inc. logoKrystal Biotech, Inc.

Quality Assurance Associate

Moon Township, Pennsylvania, United States · On-site

Mid level$546M raised

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 w…

Skills: Quality Systems, GMP, GLP, GCP, FDA Regulations

Krystal Biotech, Inc. logoKrystal Biotech, Inc.

Associate Rare Disease Sales Representative

Princeton, New Jersey, United States · Remote OK

Senior$546M raised

Position will cover a broad region along the US East Coast, across several multi-state territories. About Krystal Bio: At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the d…

Skills: Pharmaceutical Sales, Territory Management, Market Development, Relationship Building, CRM Tools

Krystal Biotech, Inc. logoKrystal Biotech, Inc.

Associate Rare Disease Sales Representative

Allentown, Pennsylvania, United States · Remote OK

Senior$546M raised

Position will cover a broad region along the US East Coast, across several multi-state territories. About Krystal Bio: At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the d…

Skills: Pharmaceutical Sales, Territory Management, Market Development, Relationship Building, Strategic Thinking

Krystal Biotech, Inc. logo

Medical Director/Senior Medical Director (Clinical Development)

Krystal Biotech, Inc.

Pittsburgh, Pennsylvania, United States • On-site

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Mid level

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  • Full-time
  • postgraduate degree
  • Posted 2d ago
  • Apply by Oct 22
  • ~40 hrs/week

Responsibilities

Lead the planning, design, and execution of Phase I through Phase III clinical trials while ensuring regulatory compliance. Manage relationships with CROs and key opinion leaders to advance the company's genetic medicine pipeline.

Requirements

Requires a Medical Degree (MD) and at least 2 years of experience in clinical research. Candidates should possess strong knowledge of GCP guidelines and the ability to work effectively within cross-functional teams.

Full job description

Medical Director/Senior Medical Director (Clinical Development)

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 skilled and motivated Medical Director/Senior Director (Clinical Development) to lead and oversee clinical research activities. The ideal candidate will have a significant role in clinical trial management and furthering the development of Krystal’s pipeline programs.  This role will be based in Krystal’s headquarters in Pittsburgh, PA.

Responsibilities will include, but are not limited to, the following:
  • Lead the planning, design, execution, and management of clinical trials from Phase I through Phase III, ensuring compliance with regulatory requirements and timelines.
  • Serve as point of contact with key opinion leaders and at scientific/regulatory meetings.
  • Support patient recruitment on assigned clinical programs, including recruitment strategy and execution in tandem with clinical sites.
  • Develop clinical trial protocols, investigator brochures, and other study-related materials.
  • Oversee site selection, study initiation, monitoring, and close-out activities in collaboration with the clinical operations team.
  • Support interactions with regulatory authorities, including meeting preparation, attendance, and authoring responses to information requests.
  • Ensure adherence to Good Clinical Practice (GCP) guidelines and other regulatory standards.
  • Collaborate with cross-functional teams, including regulatory affairs, biostatistics, data management, and medical writing, to ensure successful trial execution.
  • Manage relationships with clinical research organizations (CROs), investigators, and study sites.
  • Monitor clinical trial budgets and timelines, ensuring studies are conducted within scope and on budget.
  • Review and interpret clinical trial data, providing clinical and scientific expertise to project teams and ensuring resolution of data related issues during data and protocol deviation reviews.
  • Contribute to the preparation of clinical study reports, regulatory submissions, and publications.
  • Stay current with industry trends and advancements in clinical research and gene therapy.
  • Provide leadership and mentorship to clinical research staff, fostering a culture of excellence and continuous improvement.
Requirements and Preferred Qualifications:
  • A Medical Degree (MD) in a related field is required.
  • 2+ years of experience in clinical research.
  • Experience working on clinical trials in the biotechnology or pharmaceutical industry is a plus.
  • Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements.
  • Excellent organizational, analytical, and problem-solving skills.
  • Strong attention to detail and accuracy.
  • Ability to work independently and as part of a team.
  • Strong interpersonal and communication skills, with the ability to work effectively with cross-functional teams.
  • Proficiency in Microsoft Office Suite and clinical trial management software.
  • Willingness to travel as required.


 

Related keywords

Gene TherapyClinical DevelopmentGCPPhase I-III TrialsInvestigator BrochuresRegulatory AffairsBiostatisticsData ManagementClinical Study ReportsBiotechnologyPharmaceuticalsMedical DirectorClinical Research OrganizationsCRO

About Krystal Biotech, Inc.

LinkedInVisit site
Industry
Biotechnology
Company size
201-500 employees
Founded
2016
Headquarters
Pittsburgh, PA
LinkedIn followers
31,211
Total funding
$546M

A commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines for high unmet medical needs.

Offices: 2100 Wharton Street, Suite 701, Pittsburgh, PA 15203, US · 7001 International Dr, Moon Township, Pennsylvania 15108, US · Baarerstrasse 14-16 2nd Floor, CH-6300, Zug, CH · 23F, 4 Chrome-1-1 Toranomon, Minato City, JP

Health CareBiopharmaBiotechnology
View all jobs at Krystal Biotech, Inc.

About Krystal Biotech, Inc.

LinkedInVisit site
Industry
Biotechnology
Company size
201-500 employees
Founded
2016
Headquarters
Pittsburgh, PA
LinkedIn followers
31,211
Total funding
$546M

A commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines for high unmet medical needs.

Offices: 2100 Wharton Street, Suite 701, Pittsburgh, PA 15203, US · 7001 International Dr, Moon Township, Pennsylvania 15108, US · Baarerstrasse 14-16 2nd Floor, CH-6300, Zug, CH · 23F, 4 Chrome-1-1 Toranomon, Minato City, JP

Health CareBiopharmaBiotechnology
View all jobs at Krystal Biotech, Inc.

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