Leads in the development, evaluation, planning and execution of clinical studies
Ensures scientific integrity and interpretation of study data of a clinical development program
Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings
Maintains proficient understanding of therapeutic disease area(s) and drug candidate
Proposes, designs, and executes clinical research and development studies
Authors and/or reviews documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of Clinical Study Reports
Performs clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety
Promotes consistent first line medical/clinical data review techniques and conventions across studies/programs.
Requirements
Bachelor’s Degree, Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc) is preferred
≥ 10 years of pharmaceutical clinical drug development experience
Proven leadership experience and accomplishment in all aspects of conducting global clinical trials and execution of clinical programs
Strong cross-functional management, interpersonal and problem-solving skills
Proficient knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines.
Tech Stack
Google Cloud Platform
Benefits
health and wellness programs (including medical, dental, vision, life, and disability insurance)