Profil
Info
As a recognized thought leader in clinical development operations and project management with over 20 years of experience, I excel in navigating the intricate clinical trial ecosystem. Expertise in cell and gene therapy has driven my success in leading the development of independent business units. In my role as a Business Unit Leader, I have spearheaded organizational strategy, developed processes and SOPs, integrated cross-functional processes, and managed Operational and Program Managers.
As a patient-centric leader and strategist, I ambitiously build high-performing, cohesive teams to ensure early, high-quality program execution. My deep immersion in clinical development includes leading from concept, contributing to formulation, early strategic development during the concept phase, protocol development (IND submissions and responses), CDA, feasibility assessments, informed consents, contract and budget negotiations, NDAs, CSRs, and developing lay summaries.
As a subject matter expert in Oncology, Hematology, CGT, Autologous, Allogeneic, Rare Disease, and Pediatric Rare Disease, I bring a wealth of knowledge and experience that allows me to pivot, adapt, and innovate. This expertise ensures the successful delivery of early-phase, novel programs, evidenced by the successful enrollment of four pediatric patients identified globally for a rare gene program. Additionally, I hold certifications in Artificial Intelligence and Digital Technologies and have successfully deployed AI-enabled, integrated forecasting applications and portfolio analytics platforms at the enterprise level.
My passion for driving innovation in life sciences is reflected in my keen interest in emerging therapies, personalized medicine, and the integration of cutting-edge technologies into clinical trial design. Staying abreast of industry advancements, I continuously leverage innovations to deliver breakthrough treatments to patients.
Sheilah holds a Master's in Science and Bachelor's in Business Administration.
Certifications, Memberships
PMI PMP Kick Off: Certificate code : 5064855
Generative AI for Project Managers: PMP
Digital Research
Customer Experience in Generative AI
Association for Project Management
PMP Predictive
National Library of Medicine Member:
Region 2; NNLM ID: 96075
Abzeichen
Owner