Senior Vice President of Clinical Operations

2 weeks ago

Pittsburgh, Pennsylvania, United States Krystal Biotech Full time
Job Overview

Position: Senior Vice President of Clinical Operations


About Krystal Biotech:
At Krystal Biotech, we unite passionate and innovative individuals dedicated to the exploration, advancement, production, and marketing of genetic therapies aimed at addressing critical health challenges.


Established in 2016, Krystal stands out through its pioneering scientific approach, cutting-edge manufacturing capabilities, and a distinct commercialization strategy that prioritizes the patient experience from start to finish.


Krystal has achieved U.S. FDA approval for VYJUVEK, the first and only redosable gene therapy for Dystrophic Epidermolysis Bullosa (DEB). We continue to utilize our proprietary technology to swiftly progress a diverse pipeline of investigational genetic therapies across various fields, including respiratory, oncology, dermatology, and ophthalmology.


Headquartered in Pittsburgh, PA, we operate two advanced CGMP manufacturing facilities and maintain teams globally, with additional offices in Europe and Asia. Our organization thrives on a culture of care, courage, and scientific integrity, and we seek individuals who share these values as we expand our team.


Key Responsibilities:
  • Oversee a variety of clinical development initiatives from inception through regulatory approval and post-approval obligations.
  • Collaborate across departments with Clinical Operations and external partners to effectively manage clinical trials and observational studies, including data collection, analysis, and medical oversight.
  • Lead the creation and review of clinical documentation, including data listings, study results, and regulatory submissions.
  • Engage with global regulatory bodies, ensuring compliance and authoring necessary documentation for submissions.
  • Foster partnerships with institutions involved in clinical development.
  • Engage with thought leaders and experts to discuss study design and clinical outcomes.
  • Assess unmet medical needs in rare dermatological and pulmonary conditions, including treatment options and outcome measures.
  • Collaborate with internal and external stakeholders to prepare scientific publications and presentations.
  • Work with Medical Affairs to develop educational materials and publication strategies.
  • Represent Krystal Biotech at scientific meetings and conferences.
  • Support business development initiatives and pipeline strategies.
  • Ensure compliance with regulatory standards and Good Clinical Practice throughout study execution.

Qualifications:
  • Minimum of 10 years in clinical development, with experience in trial design and management.
  • MD with experience in the biopharmaceutical sector; MD/PhD is preferred.
  • Strong background in oncology is highly desirable, with additional experience in rare diseases and gene therapy considered a plus.
  • Proven leadership skills in clinical development and team management.
  • In-depth knowledge of FDA and EMA regulations, Good Clinical Practice, and clinical drug development processes.
  • Experience in successful IND submissions and marketing approval processes is advantageous.
  • Ability to build relationships with key opinion leaders and research institutions.
  • Understanding of statistical methods and data management in clinical trials.
  • Strong communication skills for both internal and external presentations.
  • Ability to work collaboratively in a cross-functional environment.
  • Exceptional organizational and analytical skills, with a keen attention to detail.

Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, protected veteran status, or disability status.

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