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Medical Director – Dermatology Clinical Development

Discover International

🇬🇧 English
GCP ICH guidelines Biostatistics

Job description

About the role

The Medical Director will shape the medical strategy for dermatology clinical development programs, overseeing studies from Phase I through Phase III. Reporting to senior leadership, the role serves as the primary medical contact for assigned trials and ensures scientific rigor across protocol design, safety monitoring, and regulatory interactions.

Key responsibilities

  • Lead medical strategy for dermatology programs across all clinical phases.
  • Contribute to protocol design, including endpoints, patient populations, and dosing regimens.
  • Act as medical monitor, reviewing safety data and adverse events continuously.
  • Collaborate with biostatistics, clinical operations, regulatory affairs, and pharmacovigilance on study design and execution.
  • Prepare and review protocols, informed consent forms, investigator brochures, clinical study reports, and regulatory submissions.
  • Represent the program in regulatory meetings and provide medical input for risk management plans and DSMB activities.
  • Engage with KOLs, investigators, and external dermatology experts to support site selection and study design.
  • Support publications, conference presentations, and mentorship of clinical development staff.

Required profile

  • Medical Doctor (MD) degree; board certification or training in dermatology preferred.
  • 5+ years of clinical development experience in pharma, biotech, or CRO settings.
  • Hands‑on experience across Phase I‑III dermatology trials.
  • Working knowledge of GCP and ICH guidelines.
  • Familiarity with dermatologic conditions such as psoriasis, atopic dermatitis, alopecia, or acne.
  • Experience interacting with regulatory agencies (FDA, EMA, or equivalent) is a plus.
  • Strong written and verbal communication skills and ability to work in cross‑functional global teams.

Required skills

  • Good Clinical Practice (GCP)
  • International Council for Harmonisation (ICH) guidelines
  • Biostatistics collaboration

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Published 2 months ago

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