Associate Director Clinical Research

6 days ago


London, Greater London, United Kingdom BIOMARIN Full time
Clinical Study Manager Job Description:

We are seeking an experienced Clinical Study Manager to join our team at BioMarin. The ideal candidate will have a strong background in clinical research and a passion for driving innovative medical solutions.

About the Company:
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. We are committed to creating transformative medicines for patients with significant unmet medical need.

About the Role:
This is an exciting opportunity for a highly motivated individual to take on a leadership role within our Clinical Science team. As a Clinical Study Manager, you will be responsible for overseeing clinical programs across various phases, from proof-of-concept to Phase 3 and BLA/NDA/MAA filing. You will work closely with our team to ensure excellence in clinical trial conduct, data analysis and interpretation, publication preparation, and safety monitoring.

Key Responsibilities:
* Develop key documents to support trial execution and regulatory submission
* Support the design, update and implementation of Clinical Development Plans (CDPs)
* 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 area including mechanism of action, diagnostic tests, treatment, drug development trends, and regulatory requirements

Competencies:
* Provide context and articulate key messages effectively
* Anticipate risks or issues to program or business and take necessary steps to mitigate or address
* Proactively critique clinical and scientific evidence and research and interpret how findings may impact BioMarin clinical development plans and publication plans

Education and Experience:
* MD, MD/PhD (or equivalent) degree required
* 2+ years of relevant experience in genetic diseases, metabolic diseases, specialty care, and/or rare diseases desired

Salary Information:
The estimated salary range for this position is $120,000 - $160,000 per year, depending on location and experience.

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