The Role
Lead design, execution, and oversight of Phase I-III clinical trials for gene therapy programs. Manage protocol development, site selection, CRO and investigator relationships, regulatory interactions, patient recruitment strategy, data review, budgets, and cross-functional collaboration. Provide clinical and scientific guidance, prepare regulatory/study documents, and mentor clinical research staff.
Summary Generated by Built In
Director/Senior Director of 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 Director/Senior Director of 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:
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 Director/Senior Director of 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.
- 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.
Skills Required
- Medical Degree (MD)
- 2+ years of experience in clinical research
- Experience working on clinical trials in the biotechnology or pharmaceutical industry
- Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
- Proficiency in Microsoft Office Suite
- Proficiency in clinical trial management software
- Experience planning and managing Phase I-III clinical trials
- Strong organizational, analytical, and problem-solving skills
- Strong interpersonal and communication skills and ability to work cross-functionally
- Willingness to travel as required
- Leadership and mentorship experience for clinical research staff
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The Company
What We Do
At Krystal Biotech, Inc., our mission is to make a meaningful difference in the lives of underserved patient populations suffering from debilitating skin diseases. We work to accomplish this goal through scientific innovation and operational excellence, believing that "nature operates in the shortest way possible" (Aristotle). We are a clinical-stage gene therapy company using our proprietary, engineered virus vector platform to develop effective and innovative treatments for skin diseases. While we are initially developing topical and intradermal "off-the-shelf" novel therapies for rare and orphan dermatological indications, we are expanding the use of our pioneering gene technology to target and treat other rare diseases. The diseases for which we develop therapies provide inspiration for our day-to-day activities. There is clarity in purpose, a collective empathy driving us forward. Krystal was named after this clarity — a simple realization that we can do better. In doing so, we extend gratitude to the patients, caregivers, advocates and physicians dedicated to the diseases which unite us in purpose. Community Guidelines: http://bit.ly/KrystalCG
