Senior Medical Director
Company: Krystal Biotech, Inc.
Location: Boston
Posted on: February 25, 2021
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Job Description:
Who we are:Krystal Biotech, Inc. is using gene therapy to
develop effective and novel treatments for skin diseases. Our goal
is to make a meaningful difference in the lives of underserved
patient populations with debilitating skin diseases. We work to
accomplish that through scientific innovation, operational
excellence and believe that "nature operates in the shortest way
possible". (Aristotle)Our vision:We strive to be the leader in the
development of novel and proprietary "off the shelf" gene therapy
products to fight some of the world's most serious skin diseases.
Our mission:To develop transformative, innovative, and
science-based HSV gene therapy products and processes to
dramatically improve people lives. Job Description Summary:Krystal
Biotech, Inc. is seeking a Senior Medical Director to work on
parallel development programs in different dermatological and
pulmonary genetic disorders set to enter the clinic in the next
12-18 months. The Medical Director will contribute 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. The
position is can be based in either our Pittsburgh, PA location or
Boston, MA location, however if Boston, MA based, approximately 50%
travel to Pittsburgh will be required.Specific responsibilities
include but are not limited to:* 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, 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 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.* Must be able to 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,
educational materials, 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.* Ensuring
adherence to regulatory requirements of study conduct and industry
standards of Good Clinical Practice.The ideal candidate is/has:* 5+
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.--Experience in rare disease and clinical
pharmacology preferred, with experience in pulmonary, gene therapy,
pediatrics, dermatology, 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, problem-solving abilities and strong
attention to detail while working on multiple projects in a
fast-paced, dynamic start-up and scaling environment.Krystal
Biotech, Inc. is an Equal Employment Opportunity and Affirmative
Action Employers. 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.
Keywords: Krystal Biotech, Inc., Boston , Senior Medical Director, Healthcare , Boston, Massachusetts
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