Jake Leonard Email & Phone Number

San Diego County, California, United States

San Diego, California, United States

- Manage nonclinical operations for the company’s development programs which includes coordinating with subject matter experts and consultants in the planning and design of non-GLP and GLP external toxicology and pharmacology studies; manage CRO activities in support of clinical candidate selection and regulatory filings with appropriate cost, timing, and risk assessment - Manage external toxicology, pharmacology, and bioanalytical timelines, key data, and reporting deliverables to support regulatory interactions, meet IND filing goals and support project team objectives- Partner with external consultants, operational counterparts, and CROs to coordinate and facilitate audits, study logistics/schedules/deliverables, and financial workflows - Lead the coordination of cross-functional support activities such as formulations, drug supply, immunogenicity, biomarker, and bioanalytical work in support of nonclinical safety studies - Facilitate the timing and execution of bioanalytical, toxicology, nonclinical safety, and pharmacology studies for multiple programs managed through partner CROs and ensure contracted timelines are followed while presenting these regular status updates to senior leadership - Initiate, negotiate, and manage contracts regarding bioanalytical development, toxicology, and nonclinical safety studies - Novartis Acquisition: responsible for coordinating the study report finalization that was the final term required for the close of the $1B acquisition of DTx by Novartis

San Diego, California, United States

- Strategically plan and execute all preclinical studies for multiple NDE programs at dozens of various contract research organizations (CROs).- Manage the $20M+ budget for the Nonclinical Development and Clinical Pharmacology department.- Pfizer acquisition: supported the deliverables to aid in the close of the $6.7B acquisition of Arena by Pfizer- Oversee operational excellence initiatives for the department, including document organization and IT infrastructure.- Manage external nonclinical operations for Arena’s development programs to include coordinating with internal subject matter experts and consultants in the planning and design of non-GLP and GLP external toxicology and DMPK studies with associated bioanalysis in support of clinical candidate selection and regulatory filings with appropriate cost, timing and risk assessment.- Coordinate cross-functional support activities such as formulations, drug supply, analytical, and bioanalytical work in support of nonclinical safety studies. - Lead a Well-Being team whose goal is to preserve and improve our employees’ emotional, physical, and mental well-being through personalized schedules and nutritional plans.

San Diego, California, United States

San Diego, California, United States

- Serve as the primary point of contact internally and externally for multiple client projects as they go through the drug product development process, from preformulation to manufacturing of GMP clinical supplies.- Coordinate timelines and deliverables by working with business development, R&D, manufacturing, and quality groups. Manage meetings, action items, agendas/minutes, billing, and identifying new ways that Catalent can serve clients.- Work across the Catalent global network to deliver solutions to clients by helping transfer products as they mature to commercial sites, by working with the Clinical Supply Services business unit to deliver services not offered in San Diego.- Forecast financial milestones for project phases and coordinate with the finance team to bill clients. - Assist the sales team with scope definition for resupply and new business opportunities.- Review signed proposals of assigned projects and ensure scope is accurate, and initiate proposal requests for project scope changes throughout the project lifecycle

San Diego, California

Manage 3 large programs for our highest revenue client, whose programs require full drug development and manufacturing activities across multiple Catalent sites.Led Kaizen event to optimize a $100,000 production that resulted in a 40% reduction in required time and resources.Redesigned the PM Onboarding and Training program to standardize and effectively train new project managers site wide.Manage the Customer Experience Improvement project.Create and maintain project timelines, monitor project actions, manage meeting agendas/minutes, and host client visits/audits. Write and manage proposals for assigned projects with scope spanning across multiple sites and operations.

Greater San Diego Area

Project Owner for Lean Six Sigma Greenbelt project which implemented an electronic lab notebook into the department, therefore increasing efficiency with 100% ROI in 2 years.Lead continuous improvement projects to increase the efficiency of lab operations.DOE and execution of formulation and analytical studies for parenteral drug candidates.Manage multiple clients and their corresponding projects and timelines.Lead discussions with clients on technical topics.Develop short and long term stability studies to evaluate chemical and physical stability of lead formulations.Aseptically manufacture GLP Test Articles at scale.

La Jolla, San Diego

Acting Project Manager for the Pharmaceutical Development department, handling all internal projects and CMC activities while maintaining correspondence with CROs and CMOs.Liaison between biology and chemistry groups regarding project supply and demand.Manage/Organize all formulation data within the data management system to enable easy data integrity audits.Operate all functionalities of the formulation lab including vendor requisitions, preventative maintenance of instrumentation, and safety complianceCreate and develop SOPs for all procedures and protocols of the Formulation groupEvaluate company-wide issues as a part of a CEO-appointed group instated to resolve internal unrest and revamp company culture. Formulate all dosing solutions for all pre-clinical studies, both in vivo and in vitro, to support projects at various stages of development.Safety Officer of the Formulation and Analytical laboratory.

La Jolla, California

San Diego, California, United States

Westlake Village, California, United States

Bachelor Of Science - Bs, Biochemistry

Activities and Societies: Member of Lambda Chi Alpha Fraternity, President of Student Outreach and Recruitment (SOAR) Club, Treasurer.

High School Diploma, General Education

Activities and Societies: Football Team, Volleyball Team