Medical Scientific Director, Evidence & Study Strategy

BioSpace; Kansas; Hybrid; USD 180.000 - 240.000; Vollzeit

Zusammenfassung

BioMarin is seeking a Medical Scientific Director to oversee multiple BioMarin‑sponsored and collaborative studies within one or more programs, ensuring consistency in conduct, analysis, and reporting.

You will partner with Real World Evidence (RWE)/Epidemiology, Global Medical Leads, Data Sciences and Global Study Operations to develop practical study strategies and ensure optimal hands‑on study operations and execution support for Medical Affairs‑led studies from cross functional partners.

Qualifikationen

• PharmD/PhD/MD with at least 5 years experience conducting observational and Phase IIIb/IV studies.
• MS/MPH with 10+ years similar experience.
• Experience delivering a portfolio of protocols aligned with program objectives.
• Experience responding to regulatory agency questions regarding study designs.

Aufgaben

• Study strategy and implementation for non‑interventional and interventional Phase IIIb/IV studies.
• Collaborate with Global Medical Leads, RWE, and HEOR to identify needs and opportunities.
• Lead annual/interim/periodic study reports and respond to regulatory questions.
• Present results at conferences and support regulatory submissions and inspections.

Kenntnisse

Cross-functional collaboration

Scientific writing

Ausbildung

PharmD/PhD/MD

MS/MPH

Jobbeschreibung

BioMarin is seeking a Medical Scientific Director to oversee multiple BioMarin‑sponsored and collaborative studies within one or more programs, ensuring consistency in conduct, analysis, and reporting.

You will partner with Real World Evidence (RWE)/Epidemiology, Global Medical Leads, Data Sciences and Global Study Operations to develop practical study strategies and ensure optimal hands‑on study operations and execution support for Medical Affairs‑led studies from cross functional partners.