Sugarloaf, Pennsylvania, United States
25 years of clinical development and operations experience, product development strategy consultant and management. Multi-therapeutic, global experience in drug/biologic development. Career experience highlights: • Project management and Clinical Operations experience in over 50 vaccine trials in phase I-IV. • Oncology, Ophthalmology, Internal Medicine, CNS, Respiratory, Infectious disease, vaccines, Urology • Pharmaceutical R&D transitions – mergers & acquisitions, Client and Partnership management • Management and leadership experience in various roles and military brigade chief of staff • Registered nurse with expertise in emergency/trauma medicine, critical care, pediatrics, post-anesthesia care, medical-surgical, nursing management, resource management and military medicine. • 15 years military service US Army Reserves, OIF and OEF Veteran. Executive Officer (XO) for the 8th Medical Brigade (NYC) overseeing 2 Battalions and one detachment with over 1,200 military medical personnel assigned.
Everything Clinical Operations (more to come)
As Founder & Principal Consultant at Cwierta, I guide and deliver clinical operations consulting for pharmaceutical and biotech sponsors. My role combines strategic leadership with hands-on execution, spanning: Project leadership and operational delivery across all phases and therapeutic areas Site and patient engagement strategy Vendor and CRO oversight Protocol input and study design support Budget, governance, and risk management While I serve as the primary consultant, Cwierta also draws on a trusted network of experienced professionals to provide additional expertise and scalability when projects require it. This model ensures sponsors gain both the agility of a boutique firm and the depth of seasoned industry knowledge.
Vaccine industry leader responsible for overseeing operational, financial and quality delivery of a portfolio of clinical studies across all phases of development.
Serve as clinical development and operations leader of clinical program and cross-functional team, delivering the program across all operational and development functions, overseeing program timelines, budget, quality targets and business need, managing CROs, participating on governance committees and acting as key stakeholder for vendor selections. • Drive proactive planning to navigate the team through governance and decision-point milestones. o Exceeded expectations delivering a phase three, 40,000 subject FDA submission in less than one year from FSFV. Completed ahead of schedule, below budget and with high KPIs ratings. • Drive oversight of quality metrics and ensure inspection readiness. • Oversee study team operational metrics across the study team and partners. • Lead a cross-functional team in the management and communication of risk management. • Lead preparations and presentations to relevant governance. • Lead cross-functional submissions teams for regulatory submissions.
• During COVID-19, developed over 150 vaccine and treatment strategies for clients. Operational strategist contributor to (Pharma) adaptive protocol design and accelerated approval. o Spearheaded a phase 2, COVID treatment program with MAB during the onset on COVID19. This project achieved a record-breaking start from an idea to infusing patients within 30 calendar days. • Therapeutic alignment across Parexel sponsor/partnerships, providing operational guidance, training, and clinical operations strategy. • Focused trial and clinical program development strategy for early phase through late phase development. • Created comprehensive solutions with innovation, efficacy and accelerated pathways. • Developed and maintained client relationships/partnerships, while supporting business development. • Provided technical, functional, and therapeutic expertise in the design, operational conduct and successful delivery of solutions globally. • Partnered internally with business accounts, commercial operations, and business units in developing a compelling operational, regulatory and technical strategy for a client-focused business solution. • Developed, reviewed, and analyzed in-depth risk assessments and scenario plans.
Managed and led several significant client partnership(s) for global project management while ensuring high client satisfaction, related to the program and project needs. • Coordinated proactive management approach for providing solutions to 20+ projects within the partnership. o Lead the program operations for a vaccine company during an acquisition while maintaining business objectives and solutioning project needs. • Served as lead managing project director, managed partnerships, and oversaw matrix-level project directors, project leaders and cross-functional leaders. • Managed client accounts, budgeting, resourcing, and program deliveries. • Ensured clinical partnership strategy, directly and indirectly managing, and developing staff that support the partnership and their performance. • Accountable to senior sponsor leaders and responsible for liaising with senior levels of management. • Oversaw execution and delivery of clinical operations. • Directed client engagement including the attendance at client governance/partnership-level meetings. • Created and maintained trust with the client throughout; acted as a trusted advisor and became involved in the client’s decision-making process.
Managed, led, and oversaw large and complex clinical trials and clinical trial projects. Contribute actively to proposal development teams, using knowledge and experience to develop innovative plans and program architecture. • Mentored and coached project leaders and clinical operational leaders. • Acted as sponsor liaison, project and/or program assessment and initiation, resource procurement and planning, project or program implementation, leading and motivating a cross-functional team, milestone planning and tracking, ensuring that projects or programs are progressing according to contract and quality standards, SOPs, ICH-GCP and/or other guidelines to fulfill local regulations, production of key project progress reports, management of communication between PAREXEL project team, Sponsor, contract and financial management. • Led multi-functional project teams to ensure completion of projects within defined timelines and budgets. • Accessed project resources and time reporting on an ongoing basis, track deliverables and overall program quality and efficiency.