Head of Clinical Development (Vice President)Job Description Summary: Krystal Biotech, Inc. is seeking a Vice President of Clinical Development to lead parallel development programs in different multiple therapeutic areas from the clinic through product approval. The Vice President of Clinical Development will be an integral member of the Krystal Biotech clinical team, contributing significantly to the advancement of programs into and through the clinic, and be a part of a fast-paced cross-functional team to bring these therapies through development. The direct responsibilities of this position will cover Phase 1 through Phase 3 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. This role will be based in Krystal's headquarters in Pittsburgh, PA.
Responsibilities will include, but are not limited to, the following:- Leading clinical development programs from the late preclinical stage to 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, 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 academic institutions associated with the clinical development program.
- 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.
- Support patient recruitment on assigned clinical programs, including recruitment strategy and execution in tandem with clinical sites.
- Must be able to critically evaluate and understand the unmet medical needs in various therapeutic areas, 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, educational materials, and publication strategy.
- Represent Krystal Biotech, Inc. externally where necessary through publications, and presentations at scientific meetings and congresses, both domestically and internationally.
- Work collaboratively to assist with business development and pipeline activities.
- Ensuring adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice.
Requirements and Preferred Qualifications:- Ten (10) years of clinical development experience, including designing and managing clinical trials, authoring clinical trial protocols and study reports, and creating clinical development strategies.
- MD with biopharmaceutical industry experience and translational medicine experience. Experience in rare disease and clinical pharmacology preferred.
- 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 is 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, problem-solving abilities and strong attention to detail while working on multiple projects in a fast-paced, dynamic start-up and scaling environment.
