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 • 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 • Develop thorough understanding of clinical trial data to help guide the drafting of CSRs and Key Messages. • 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 the scientific subject matter expert, and primary contact, for assigned clinical study; take a proactive approach to identifying issues and mitigating risk • Initiate and provide the scientific content and insight for development and review of protocols, protocol amendments; ICFs; CRFs; statistical tables and listings including accurate AE (MedDRA) and concomitant medications (WHODrug) coding; audit reports; clinical study reports; inspection readiness activities, regulatory submissions and other key study deliverables • Proactively identify and communicate potential risks and mitigations relevant to the Clinical Science deliverables

Requirements

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