Vice President of Clinical Development

4 weeks ago

Pittsburgh, United States Krystal Biotech Full time
Job DescriptionJob DescriptionVice President of Clinical Development

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 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 Vice President of Clinical Development to lead and oversee an active pipeline across multiple therapeutic areas including (but not limited to) dermatology, pulmonary, ophthalmology, oncology, and rare diseases.  The Vice President of Clinical Development will be an integral member of the Krystal Biotech leadership team, contributing significantly to the advancement of programs ranging from pre-clinical candidates, ongoing clinical trials and our US-approved commercial treatment, VYJUVEK®. The direct responsibilities of this position will cover several clinical phases and post-approval activities, expanding and advancing the Company’s programs from early clinical trial development to proof-of-concept and commercialization. This Vice President will be in a high-profile and high-impact position, responsible for executing and delivering on critical clinical milestones, and will also be integral to the clinical development strategy.

Primary Responsibilities:
 
  • Leading a range of clinical development programs from various phases through registration and completion of post-approval commitments.
  • Work cross-functionally with Clinical Operations and/or vendors to successfully execute clinical trials and natural history studies. These activities may consist of coordination, collection and analysis of clinical data and reporting, and providing ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance.
  • Manage the preparation and/or review of data listings, summary tables, study results, study reports, and clinical/regulatory/safety documents, investigator brochures, and clinical development plans.
  • Interact with global regulatory agencies and have responsibility for authoring and/or reviewing relevant Pre-IND, IND, and BLA sections and generating responses.
  • Close collaboration with institutions associated with the clinical development programs.
  • Engage with thought leaders, investigators, cooperative groups, and other experts in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results.
  • Critically evaluate and understand the unmet medical needs in various rare dermatological, pulmonary disorders, outcome measures, treatment options, etc.
  • Partner with internal and external key stakeholders to develop manuscripts for publication in peer-reviewed journals and preparation of presentations for scientific conferences as well as for clinical study investigator meetings and expert clinical advisory meetings.
  • Collaborate with Medical Affairs in developing medical slide decks and educational materials, and publication strategy.
  • Represent Krystal Biotech, Inc. externally where necessary through publications, presentations at scientific meetings and congresses, both domestically and internationally.
  • Work collaboratively to assist with business development and pipeline activities.
  • Ensure adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice.

Requirements and Desired Qualifications:
 
  • 10+ years of clinical development experience, including designing and managing clinical trials, authoring clinical trial protocols and study reports, and developing clinical development strategy.
  • MD with biopharmaceutical industry experience and translational medicine experience.  MD with PhD preferred.
  • Experience in oncology is highly preferred, with experience in rare disease, clinical pharmacology, pediatrics, dermatology, pulmonary, oncology, gene therapy, or internal medicine a plus.
  • Demonstrated leadership in a clinical development capacity and team-building skills as well as the ability to perform effectively in a dynamic and evolving environment.
  • Excellent working knowledge of FDA and EMA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development. Experience in representing the sponsor in front of regulatory agencies and obtaining regulatory approval preferred.
  • Successful submission of INDs and submission of marketing approval-directed filing(s) (BLAs, NDAs, and MAAs) is preferred.
  • Ability to create an active network with KOLs, key research centers, patient advocacy groups, and a variety of patient care organizations.
  • Understanding of statistics and data management considerations for clinical trial design and scientific communications.
  • Knowledge of medical monitoring of clinical trials required (e.g., responding to questions about patient eligibility and protocol waivers; review of safety parameters; receiving and processing SAEs, including the composition of SAE narratives; and IND expedited safety reports).
  • Strong communication (oral, written) skills to present internally and at scientific meetings and author medical documents and scientific publications.
  • Ability to collaborate with internal and external stakeholders and diverse workforce within a cross-functional matrix environment.
  • Exceptional organizational, analytical, critical thinking, and problem-solving abilities and strong attention to detail while working on multiple projects in a fast-paced, dynamic environment.


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 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.
 

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