Medical Director

Posted 3ds ago

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Job Description

Medical Director managing local medical infrastructures and leading medical plan implementation for Krystal Biotech in Spain. Engaging with KOLs and advocating for novel gene therapies.

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 in 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.

Requirements:

  • 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 progressing of increased responsibilities.
  • Proven track record and experience of revision and approval of scientific and promotional materials according to 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).

Benefits:

  • Equity / Stock Options
  • Medical and Prescription Drug Coverage
  • Dental and Vision Insurance
  • Short and Long-Term Disability Insurance
  • 401(k) With Company Match
  • Paid Holidays
  • Paid Time Off
  • Flexible Spending Accounts (Health Care & Dependent Care)
  • Employee Assistance Program & Benefits Concierge App
  • AD&D and Life Insurance
  • Wellness Rewards Program