Study Manager

3 days ago


London, Greater London, United Kingdom BIOMARIN Full time

Are you looking for a challenging opportunity to make a difference in the lives of patients with rare genetic diseases? We are seeking an experienced Study Manager to join our team at BioMarin. The successful candidate will oversee clinical programs across various phases, from proof-of-concept to Phase 3 and BLA/NDA/MAA filing.

Key Responsibilities
  • Develop key documents to support trial execution and regulatory submission (including IND Annual Reports, Investigator Brochures, Briefing Books, and Pediatric Plans)
  • Support the design, update, and implementation of Clinical Development Plans (CDPs) and work with Project Management to ensure progress in line with current plans and timelines
  • Develop scientific rationale for methods, design, and implementation of clinical protocols, data collection systems, and final reports
  • Stay up-to-date with advances in literature in therapeutic/disease areas, including mechanism of action, diagnostic tests, treatment, drug development trends, and regulatory requirements
  • Develop therapy-specific publication plans and work with internal and external colleagues to prepare study results for timely publication
  • Attend and contribute to relevant scientific conferences, seminars, or presentations
Requirements
  • Advanced degree in life or health sciences (e.g., PhD, PharmD, RN)
  • At least 2 years of experience in genetic diseases, metabolic diseases, specialty care, and/or rare diseases
  • Excellent communication and collaboration skills
  • Ability to work effectively in a fast-paced environment

The estimated salary for this position is $130,000 - $200,000 per year, depending on experience, plus benefits and opportunities for growth and development.



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