Head of Clinical Development (Vice President)

Thanks for visiting our Career Page. Please review and apply to our positions which match your qualifications.Krystal Biotech, a Pittsburgh-based company founded in 2016, has quickly emerged as a global leader in gene therapy.

In May 2023, Krystal Bio received FDA approval for the first-ever redosable gene therapy, VYJUVEK™, for the treatment of Dystrophic Epidermolysis Bullosa. Krystal continues to leverage their proprietary platform to develop new treatments throughout its clinical pipeline.

Additionally, the company has developed innovative commercial- and clinical-stage manufacturing processes, deployed across two state-of-the-art GMP facilities.BenefitsWe make every effort to provide essential and desirable benefits that make each employee's life that much easier. In addition to benefits listed below, we also offer competitive compensation that rewards you for your contributions toward achieving company goals.Benefits include:Equity / Stock OptionsMedical and Prescription Drug CoverageDental and Vision InsuranceShort and Long-Term Disability Insurance401(k) With Company MatchPaid HolidaysPaid Time OffFlexible Spending Accounts (Health Care & Dependent Care)Employee Assistance Program & Benefits Concierge AppAD&D and Life InsuranceWellness Rewards ProgramHead of Clinical Development (Vice President)Pittsburgh, PAFull TimeClinical DevelopmentExperiencedShareHead of Clinical Development (Vice President)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 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 communicationsKnowledge 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 publicationsAbility to collaborate with internal and external stakeholders and diverse workforce within a cross-functional matrix environmentExceptional 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.ShareApplyApply for this positionRequired*First Name*Last Name*Email Address*Phone*Address*Resume*We've received your resume.

Clickhereto update it.Attach resumeorPaste resumeAttach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) orPaste resumePaste your resume here orAttach resume fileDesired salary*Earliest start date?*Do you have a Medical Degree (MD)?*-- No answer --YesNoDo you live in Pittsburgh, or are you willing to relocate to Pittsburgh and work in Krystal's HQ 5 days/week?*-- No answer --YesNoHuman Check*Submit Application