Director/Executive Medical Director- Inflammation – Biotech

Director/Executive Medical Director- Inflammation

Director/Executive Medical Director- Inflammation

February 13th, 2020 by

Responsibilities:

  • Develop and execute global clinical development strategy, and communication of the global scientific/medical evidence plan for multiple indications
  • Provide clinical/scientific input during the development and execution of clinical trials, including key observational studies
  • Provide clinical content input to:
    • Regulatory interactions and documents
    • Safety interactions and documents
  • Seek global cross-functional collaborations to integrate broad medical, scientific, and commercial and payor input into the development program
  • Provide clinical input into safety and regulatory submissions/interactionsand participate in regulatory interactions
  • Interpretation and communication of clinical trial data

 

Preferred Qualifications

  • MD with PhD in Immunology
  • 5+ years of biopharma experience with strong and versatile clinical development experience in inflammation such as RA, SLE, IBD: and accreditation in relevant sub-specialty (i.e. rheumatology, immunology, dermatology)
  • Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes
  • Experience with developing study concepts for clinical development and clinical trial designs with cross functional input, including biostatistics, observational research and patient reported outcomes in Phase 1,2 and/or 3 clinical trials in inflammation/immunology
  • Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
  • Prior regulatory experience with familiarity with FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements

Location: Los Angeles

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