Global Medical Affairs Leader, Director, Dermatology

hace 7 días

Madrid, Madrid, España Importante empresa A tiempo completo
Job Summary

We are seeking a highly experienced Global Medical Affairs Leader, Director, Dermatology to join our team at Importante empresa. This is a key role that will lead the clinical-commercial optimization of product development and life cycle management strategies and plans for the assigned marketed compounds and compounds in clinical development within the Immunology Therapeutic Area.

Key Responsibilities:
  1. Develop and execute a comprehensive Global Medical Affairs strategy and plan for the assigned compounds based on prioritized regional needs.
  2. Collaborate with cross-functional teams to ensure integration with the overall global compound strategy, resulting in one Global R&D and Medical Affairs compound development plan.
  3. Provide a single Medical Affairs voice into the creation of compound development and LCM strategies, plans, and trial design from phase IIa through phase IV.
  4. Lead pre-launch Medical Affairs activities, including product/Therapeutic Area global advisory boards, medical symposia, and congress activities, and coordinate regional activity in these areas.
  5. Be an active member of the Compound Development Team and lead a Global Medical Affairs Team consisting of regionally designated Therapeutic Area Medical Affairs Leaders to create one Medical Affairs perspective and one unified voice on the team.
  6. Collaborate closely with regional Medical Affairs representatives to develop integrated Global Medical Affairs strategies and plans and maintain open, two-way communication to ensure regional Medical Affairs is up to date on all plans, progress, and decisions.
  7. Synchronize input and output of the Medical Affairs plan with the strategic and business plan calendars.
  8. Maintain responsibility for the development and execution of global publication plans as well as review and approval of publications for marketed products and specified compounds in clinical development.
  9. Lead the ReCAP process (review of all Medical Affairs sponsored clinical trials and Investigator Initiated Sponsored studies) for applicable products.
  10. Support the development of the Company risk management strategy and plan as well as author and review specific sections of the Periodic benefit-risk assessment report for compounds.
  11. Perform medical impact assessments as required.
  12. Maintain responsibility for ensuring that all global activities follow Importante empresa Compliance principles.
Qualifications:
  • A minimum of a Pharm D., Ph.D., or MD degree (or equivalent) is required with specialty training and certification in dermatology preferred.
  • Extensive clinical and/or pharmaceutical experience in Immunology is required. Experience in dermatology disease areas and having an established network with medical experts/opinion leaders in dermatology are highly preferred.
  • A minimum of 5 years of combined relevant experience in a medical/clinical environment and/or scientific function in the pharmaceutical industry is required; at least three years in the Medical Affairs environment is highly desirable.
  • Knowledge of products, both Importante empresa and competitors, in the Therapeutic Area.
  • A demonstrated track record of success within Medical Affairs and/or Clinical R&D.
  • In-depth knowledge of study methodology, study data reviews, and analysis.
  • Excellent knowledge of study execution, benefit-risk management, and regulatory affairs.
  • Proven ability to act as a medical spokesperson for external audiences is required. Also required is strong experience developing and managing strategic relationships with medical experts/opinion leaders.
  • Proven track record on ethics and Importante empresa principles.
Competencies/Skills:
  • Strategy Development Expertise
  • Adaptability and Flexibility / Managing internal and external relationships
  • Product Development Expertise and Product/Brand Awareness
  • Organization and Project Management
  • Customer and Market Insight

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