Descripción de la oferta
Medical Director, Spain
Based in Spain.
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 is seeking a highly motivated Medical Director for Spain. We are a rapidly growing company with an entrepreneurial spirit looking for someone to build the local medical infrastructures and capabilities and lead the implementation of the medical plan and other key medical affairs initiatives in country. In full collaboration with other internal and external relevant stakeholders, following the global defined vision and strategy, and according to the highest ethical and compliance standards.
Specific Responsibilities
Build and maintain excellent relationships with Key Opinion Leaders (KOLs) and medical teams at the treatment centres.
Be a visible and active member of the medical community to raise awareness of Krystal Biotech and the specific novel gene therapy treatments it is bringing to underserved patients.
Be the scientific referent for local patient advocacy groups (upon request).
Support the building of the country medical infrastructures and capabilities.
Actively participate in the country leadership team bringing your medical expertise to frame better decisions.
Effectively present externally at scientific conferences and to high-level scientific or business audiences.
Input into medical affairs strategy for B-VEC or other Krystal Biotech products within the assigned country or region. Contribute to the scientific communication strategy with key focus on implementing the medical communication and publication national plans.
Contribute to the evidence generation plan (beyond Phase II and III clinical studies), with special focus at national level, including adequate follow‑up of all unsolicited investigator‑initiated studies proposals and support to all potential Krystal Biotech sponsored late‑phase research projects.
Scientifically educate on the correct use of B‑VEC and other Krystal Biotech products according to approved labels.
Drive the organization and implementation of Local and/or Regional Advisory Boards and other scientific meetings.
Interpret scientific data from the literature and/or from clinical studies.
Partner with the market access, marketing, and commercial teams, including providing adequate ongoing scientific training in disease and product related areas.
Actively participate in the creation and/or review of the reimbursement dossiers and any associated discussions with external stakeholders, in close partnership with the market access team.
Address adequately all unsolicited medical questions according with all applicable regulations and internal policies.
Support all pharmacovigilance activities, namely reporting and following up adequately and according with all applicable regulations for any reported adverse event.
Review all medical and promotional materials to be used at national level, to ensure the accuracy of information and compliance with all applicable laws and regulations.
Ensure compliance with both the letter and spirit of all laws and regulations. Remain alert to any potential compliance issues that may arise, seeking counsel through proper channels if such issues are identified.
Qualifications and Skills
Life science degree (MD, PharmD, MSc., PhD or equivalent), MD and PhD degrees preferred.
Entrepreneurial mindset and ability to work in a start‑up environment.
Ability to build relationships and collaborate with others to achieve mutual objectives.
Strategic thinking, strong analytical skills, sharp business judgment, thorough knowledge of scientific information, and the ability to interpret and assimilate scientific data.
Good understanding of the key pre‑clinical and clinical trial design elements, operations, and interpretation of these activities as well as regulatory requirements.
Excellent oral and written communication and skills. Proven ability to present critical medical and scientific information to diverse audiences, and to positively interact with external customers, medical thought leaders, academic and managed care communities.
Fluent in English and the country mother tongue(s).
Willingness and availability to travel frequently, in country and abroad.
Significant diverse medical affairs experience, showing a clear progression of increased responsibilities.
Proven track record and experience of revision and approval of scientific and promotional materials according with all applicable regulations.
Experience in pre‑launch and launch medical activities, with proven track record of prior launches.
Proven track record of establishing and maintaining professional relationships at all levels (inside and outside the company).
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