Director/Executive Medical Director- Inflammation

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