Associate Medical Director - Clinical Science

November 7

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BioMarin Pharmaceutical Inc.

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Transform lives through genetic discovery.

1001 - 5000

💰 Post-IPO Debt on 2020-05

Description

• Develop key documents to support the components of 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 area 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 • Engage and establish rapport with KOLs and scientific or clinical experts • Contribute to content and submission of abstracts to key symposia • Work with CLS and Clinical Operations to ensure the success of Investigator Meetings by contributing and presenting scientific content • Perform preliminary analyses on clinical study data as it becomes available to help build and guide Statistical Analysis Plans (SAPs) • Help define study quality metrics and perform study data reviews during study execution to ensure integrity of accruing study data • Act as study scientific subject matter expert and main point and of contact for Principal Investigators (PIs) and sites to assess subject eligibility, provide scientific rational and manage ongoing protocol issues

Requirements

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