Medical Director/Senior Medical Director (Clinical Development)

Krystal Biotech•Pittsburgh, PA

2d•Onsite

About The Position

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.

Requirements

A Medical Degree (MD) in a related field is required.
2+ years of experience in clinical research.
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.

Nice To Haves

Experience working on clinical trials in the biotechnology or pharmaceutical industry is a plus.

Responsibilities

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.