Medical Scientific Director

This is a fully remote position, open to applicants in United States.

📋 Description

• Supervise the daily operations of BioMarin-sponsored and collaborative studies within a specific therapeutic area.

• Ensure uniformity in study methodology, execution, oversight, analysis, and reporting across various programs.

• Collaborate with RWE/Epidemiology, Global Medical Leads, Data Sciences, and Global Study Operations to formulate study strategies and facilitate implementation.

• Implement non-interventional, low-interventional, and interventional Phase IIIb/IV evidence-generation initiatives.

• Create strategic plans for study pull-through and dissemination.

• Identify challenges in study implementation, lead the development of complex solutions, and escalate as necessary.

• Provide scientific insights on study concepts, protocols, amendments, statistical analysis plans, data review plans, and regulatory responses.

• Oversee the creation of annual, interim, and periodic study reports, coordinating input from subject-matter experts and interpreting data.

• Design plans for secondary data analysis utilizing both clinical and real-world data.

• Offer medical monitoring oversight, including subject eligibility, safety and data quality, ICFs, CRFs, TLGs, coding, and readiness for inspection.

• Present study findings to both internal and external stakeholders, including at scientific conferences.

• Coordinate Medical Affairs contributions for regulatory submissions, regulatory inquiries, IRB/Ethics Committee questions, inspections, and audits.

• Engage in initiatives aimed at enhancing study implementation efficiency.

⛳️ Requirements

• PharmD/PhD/MD with a minimum of 5 years of experience in conducting observational and Phase IIIb/IV studies in Clinical Development and/or Medical Affairs; or MS/MPH with over 10 years of comparable experience.

• Proven experience in delivering a portfolio of protocols that align with strategic program goals.

• Familiarity with responding to regulatory agency and IRB/Ethics Committee inquiries concerning study designs and protocol execution.

• Demonstrated success in collaborating with cross-functional partners to ensure the effective end-to-end delivery of studies that support product Integrated Evidence Plans.

• History of producing high-quality novel observational and Phase IIIb/IV studies.

• Capability to operate efficiently within a cross-functional matrix environment.

• Knowledge of innovative prospective observational and interventional study designs.

• Comprehension of statistical and data analysis, as well as research methods and design.

• Experience in study monitoring.

• Advanced understanding of the clinical research process and Good Clinical Practice/Pharmacoepidemiology Practice standards and requirements.

• Exceptional scientific writing and document development skills.

🏝️ Benefits

• Comprehensive health and wellness plans.

• Opportunities for professional development and growth.

• A collaborative work environment fostering innovation and creativity.

• Competitive compensation and performance-based incentives.