Clinical Study Director

2 weeks ago

London, Greater London, United Kingdom BioMarin Full time
Overview

BioMarin is a pioneering biotechnology company driven by bold scientific discoveries to develop innovative medicines that advance human health. Founded in 1997, we have harnessed our expertise in genetics and molecular biology to create transformative treatments for patients with significant unmet medical needs.

Job Description

We are seeking an experienced Clinical Study Director to join our team of experts in genetic diseases. As a key member of our Clinical Science department, you will be responsible for overseeing clinical programs across various phases, from proof-of-concept to Phase 3 and regulatory filings.

Responsibilities
  • Lead clinical study execution and regulatory submissions, ensuring excellence in trial conduct, data analysis, and interpretation.
  • Develop key documents, including Investigator Brochures, Briefing Books, and Pediatric Plans, to support trial execution and regulatory submissions.
  • Support the design, update, and implementation of Clinical Development Plans (CDPs), collaborating with Project Management to ensure progress aligns with current plans and timelines.
  • Stay up-to-date with advances in literature in therapeutic areas, including mechanism of action, diagnostic tests, treatment trends, and regulatory requirements.
Requirements
  • MD or MD/PhD degree (or equivalent) with 2+ years of experience in genetic diseases, metabolic diseases, specialty care, or rare diseases.
  • Proven track record of success in clinical study management, with expertise in drug development, data analysis, and scientific writing.
  • Strong understanding of clinical study protocol scientific rationale, methodology, biostatistical concepts, and data analysis procedures.
  • Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams and external stakeholders.
Salary

The estimated salary range for this position is $140,000-$180,000 per annum, depending on qualifications and experience.

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