Medical Scientific Director

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 10%

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BioMarin Pharmaceutical Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 Post-IPO Debt on 2020-05

Healthcare • Biotechnology • Pharmaceuticals

BioMarin Pharmaceutical Inc. is a leading global biotechnology company dedicated to transforming genetic discoveries into innovative medicines. Founded in 1997, the company has developed eight marketed products that address life-threatening genetic and lysosomal storage disorders such as achondroplasia and severe hemophilia A. BioMarin is also heavily invested in research and development, with a robust pipeline of investigational medicines at various clinical trial stages. The company's mission revolves around improving patient care by leveraging scientific expertise to understand the underlying causes of these conditions. BioMarin is committed to inclusivity and patient advocacy, engaging closely with communities to enhance care and quality of life for those with rare conditions.

📋 Description

• Oversee day-to-day conduct of BioMarin-sponsored and collaborative studies across a therapeutic area • Ensure consistency of study approach, conduct, monitoring, analysis and reporting across programs • Partner with RWE/Epidemiology, Global Medical Leads, Data Sciences and Global Study Operations to develop study strategies and support execution • Execute non-interventional, low-interventional and interventional Phase IIIb/IV evidence-generation activities • Develop strategic study pull-through and dissemination plans • Identify study implementation issues, lead complex solutions and escalate as appropriate • Provide scientific input on study concepts, protocols, amendments, statistical analysis plans, data review plans and regulatory responses • Lead annual, interim and periodic study reports, coordinating subject-matter-expert input and data interpretation • Design secondary data analysis plans using clinical and real-world data • Provide medical monitoring oversight, including subject eligibility, safety and data quality, ICFs, CRFs, TLGs, coding and inspection readiness • Present study results to internal and external stakeholders, including scientific conferences • Coordinate Medical Affairs input for regulatory submissions, regulatory queries, IRB/Ethics Committee questions, inspections and audits • Participate in initiatives to improve study implementation efficiency

🎯 Requirements

• PharmD/PhD/MD with at least 5 years experience conducting observational and Phase IIIb/IV studies within Clinical Development and/or Medical Affairs; or MS/MPH with 10+ years similar experience • Experience delivering a portfolio of protocols and ensuring they meet strategic program objectives • Experience responding to regulatory agency and IRB/Ethics Committee questions regarding study designs and protocol conduct • Proven track record working with cross-functional partners to ensure successful end-to-end delivery of studies supporting product Integrated Evidence Plans • Track record delivering high-quality novel observational and Phase IIIb/IV studies • Ability to work effectively in a cross-functional matrix setting • Awareness of novel prospective observational and interventional study designs • Understanding of statistical and data analysis, research methods and design • Experience in study monitoring • Advanced knowledge of the clinical research process and Good Clinical Practice/Pharmacoepidemiology Practice standards and requirements • Strong scientific writing and document development