Leanne Leonard

Providing clinical expertise and experience in the CRO industry to start up, pharma, biotech and investment firms.

• Company Overview: Usona Institute is a non-profit medical research organization dedicated to supporting and conducting preclinical and clinical research to further the understanding of the therapeutic effects of psilocybin and other consciousness-expanding medicines
• Successfully launched PSIL301 -Usona’s pivotal phase III psilocybin study (MDD). Including CRO selection and contracting, strategic study design, planning, and oversight of the CRO and trial sites.
• Ensured on time site initiation and enrollment in alignment with Usona’s organizational goals and objectives
• Oversaw all aspects of clinical operations to ensure the highest standards of clinical study execution
• Collaborated with cross-functional and external stakeholders and oversee all aspects of clinical trial execution and department initiatives
• Responsibility for driving the development of comprehensive strategies to optimize clinical trial design, data collection, analysis, and inspection readiness for successful regulatory submissions
• Oversaw a team of Clinical Operations professionals as well as clinical trial in vendor selection and vendor/CRO oversight

• Provided senior oversight to Project Teams and accountable for project productivity, delivery and quality resulting in strong financial performance and customer satisfaction
• US Head of Clinical Operations with accountability for Clinical Monitoring, Clinic and Line management and oversight of study and site teams (including CRA's, PM's, Clinic Directors, CRC's and CTA's)
• Responsible for driving operational excellence and strategic leadership with the customer
• Included managing an assigned team who support studies or programs to make sure quality, time and budget deliverables were met to the Sponsor's satisfaction and in accordance with SOPs, policies and practices
• Accountability for MedTech operations and clinics with responsibility for finding and operationalizing multiple research facilities/clinics within the US to meet the needs of a client
• Includes facility selection, design and site refit / renovation, all hiring and resourcing and full accountability for the facilities and the P&L
• Serves as executive contact for the sponsor with accountability for the success of the relationship and program

• Accountable for a partner's portfolio of work within the Neuroscience therapeutic area
• Included strategic and operational governance and oversight of the planning, resourcing, and operational delivery
• Directs large, global, multi-functional projects or programs (Phase I-IV), including the execution of the clinical component of the project/program to the Sponsor's satisfaction, ensuring quality deliverables, on time delivery and within budget
• Strategic decision-making responsibility for the program and portfolio
• Coached and mentored team around project planning, project review, risk management and problem solving, proactively managing risks linked to resourcing, project and/or individual needs with other management and leadership team members to manage study issues and obstacles
• Provided consultation to clients on drug development process, strategy, and plans
• Member of the CNS Leadership team and key member of the sponsors governance and oversight committees

• Accountable for all projects within the therapeutic areas of Rare Disease, Plasma Derived Therapies and Neuroscience
• Directed and managed large, global, multi-functional projects or programs (Phase I-IV), including the execution of the clinical component of the project/program to the Sponsor's satisfaction, ensuring quality deliverables, on time delivery and within budget
• Had strategic decision-making responsibility for the project/program
• Ensure that all project work is completed in accordance with SOPs, policies, and practices

• Company Overview: Global Early Development Services
• Accountable for delivery of the Early Development (Phase 1) Book of Work (BOW) globally
• Served as the primary executive contact for the entire EDS organization
• Oversaw all early development programs to enhance the achievement of the sponsor's short-term and long-term portfolio, strategy, and objectives
• Responsible for placement and execution of the BOW within the PRA Phase I clinics, Patient Pharmacology Sites and Bioanalytical labs
• Led effort on continuous evaluation of processes to identify inefficiencies, remediate issues to ensuring and maintaining the company's competitive advantage
• Led development of standardized solutions, core processes and metrics
• Ensured regulatory compliance of all operations
• Ensured appropriate early clinical/strategic input to company decisions
• Led and contributed to client meetings and bid defenses
• Provided operational and strategic input in crafting of innovative novel approaches to studies as well as to the program framework and operating model
• Key member of both the Strategic Management Committee and Operational Management Committee
• Global Early Development Services

• Partnered with business development staff and operational leaders to design innovative, practical, and fiscally responsible strategies for clinical trials
• Using an evidence-based approach developed the site and country mix and operational execution to provide unique approaches while maintaining quality, successful implementation and conduct of clinical trial programs for clients within the therapeutic area
• Required in depth knowledge of the therapeutic area, landscape, and regulatory environment to develop unique and creative ways of meeting the sponsor's goals and timelines
• Supported all aspects of business development and commercial operations, for regional and global trials
• Position held full accountability, and responsibility, for proposal development, strategy, budgeting and leading of bid defenses
• Led global core team to ensure action performance is in line with strategic plan and provides advanced interventional guidance when required

• Role required finding unique and creative ways of meeting the sponsor's corporate goals and timelines while maintaining the highest degree of safety and quality
• Emphasis on adaptive designs and hybrid protocols, through Proof of Concept (POC)
• Partner with Early Phase Development Solutions group to support fully outsourced clinical development from pre-IND through POC including both rare diseases and pediatric populations
• Provided experience and expertise in protocol design, country and site selection and created both budgets and timelines for early phase patient trials in the therapeutic areas
• Partnered with Early Phase Development Solutions group to support fully outsourced clinical development from pre-IND through POC
• Provided both functional support and governance/oversight during trial execution

• Responsibility the management, administration, and organization of local site operations for Clinical Pharmacology
• Overall responsibility for ensuring efficient utilization of all resources allocated to the group, both human and physical, as well as responsibility for the facility and P&L
• Accountability for identifying, measuring, and improving key processes to increase quality, customer satisfaction, operational efficiency, employee retention, and profitability
• Led and implemented change across multiple business units
• This includes the performance of the site and the needs of clients through Process Excellence
• Served as a key member of the Senior Leadership team and required overseeing of a team of 80+ individuals including MD's, pharmacists, nurses, and scientists
• Participated in all aspects of sales and commercial operations

• Was responsible for the management, administration, and organization of the Study Operations Department
• Provided leadership, training, coaching, and mentoring of clinical operations staff

• Led a team consisting of registered nurses, licensed practical nurses, and medical technicians
• Served as the primary contact for sites and Sponsor and directly communicated all facets of studies to the study team
• Assisted with the development of protocols, responsible for IRB submissions and approvals along with management of all lab activities and external vendors
• In close relationships with the Principal Investigator/Medical Monitor and study team provided both scientific, safety and operational strategy and considerations