Associate Medical Director - Clinical Science

November 7

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Logo of BioMarin Pharmaceutical Inc.

BioMarin Pharmaceutical Inc.

Transform lives through genetic discovery.

1001 - 5000 employees

Founded 1997

🧬 Biotechnology

πŸ’Š Pharmaceuticals

πŸ’° Post-IPO Debt on 2020-05

Description

β€’ Develop key documents to support the components of trial execution and regulatory submission (including IND Annual Reports, Investigator Brochures, Briefing Books and Pediatric Plans) β€’ 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 β€’ Develop scientific rationale for methods, design and implementation of clinical protocols, data collection systems and final reports β€’ 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 β€’ Develop therapy-specific publication plans and work with internal and external colleagues to prepare study results for timely publication β€’ Act as study scientific subject matter expert and main point of contact for Principal Investigators (PIs) and sites to assess subject eligibility, provide scientific rational and manage ongoing protocol issues β€’ Conduct periodic review of protocol deviations in collaboration with Clinical Operations Study Lead or designee (per protocol specific Protocol Deviation Plan) β€’ Provide timely and high-quality functional deliverables and contributions to Study Execution Team (SET)

Requirements

β€’ 2 or more years of relevant experience in genetic diseases, metabolic diseases, specialty care, and/or rare diseases desired; Clinical experience preferred

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