Leads the development, evaluation, planning and execution of clinical studies
Ensures scientific integrity and interpretation of study data
May function as lead Clinical Scientist for program
Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings
Applies advanced scientific expertise to propose, design, and execute clinical research
Develops the Expanded Synopsis and authors clinically relevant sections
Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines
Independently leads planning and prepares information for external/stakeholder meetings
Ensures consistent first line medical/clinical data review techniques and conventions
Identifies areas of potential inconsistent data review and implements solutions

Requirements

BS/MS/PhD/PharmD
≥ 10 years of pharmaceutical clinical drug development experience
Experience in managing cardiovascular and/or metabolic and/or immune/inflammatory related clinical trials is preferred.
Advanced knowledge of the global drug development process
Good Clinical Practice, complex study design, clinical research methodology & medical writing skills

Benefits

health and wellness programs (including medical, dental, vision, life, and disability insurance)
fitness centers
401(k) company match
family support benefits
equity awards
annual bonuses
paid time off
paid leaves (e.g., military and parental leave)