Jerome Bailey's Location
Greater Philadelphia, United States, United States
Jerome Bailey's Contact Details
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About Jerome Bailey
As the VP of Operations at Longeveron, a biotechnology company focused on developing regenerative therapies, I provide strategic leadership and management direction to ensure the delivery of projects and programs within cost, time, and quality requirements. With over 25 years of experience in the pharmaceutical and biotech industry, I have diverse expertise in early and late phase clinical development, operational management, third-party vendor management, licensing, and CRO management.I am passionate about creating and executing global development plans that align with the company's vision and goals, and that leverage the best practices and technologies in the field. I have successfully led oncology programs through the transition from candidate selection to clinical development, and have recruited and trained a diverse global pharmaceutical development workforce across multiple therapeutic areas. I am also skilled in customer relationship management, mentoring, and communicating about culturally sensitive issues, as demonstrated by my certifications and courses. My mission is to collaborate within the organization and with external stakeholders to deliver innovative and high-quality solutions that improve the lives of patients.
Jerome Bailey's Current Company Details
Jerome Bailey Work Experience Details
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Co-FounderDiversity Health NetworxPhiladelphia, Pa, Us
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Principal Owner - FreelanceBailey Clinical Services, Llc Feb 2024 - PresentContract | Consultant services in project and program management, clinical operations, vendor/CRO oversight and portfolio management.
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Vice President Business OperationsLongeveron Inc Sep 2022 - Apr 2024Miami, Florida, UsLed strategic and tactical oversight of clinical operations, program development departments including proposal development, operational staff (clinical project managers (CPM), CRAs and QA Auditors), and finances. Managed client vendor relationships and helped implement internal process improvements.Led development of Integrated Development Plan (IDP), Investigator Medicinal Product Dossier (IMPD), Targeted Patient Profile (TPP), Investigator Initiated Trials (IITs) and other critical documents that help to classify assets for commercialization.Direct responsibility for Clinical Operations, Human Resources, Information Technology, Quality Assurance and Outsources.Reported directly to CEO while working closely with the CFO on budgets, General Counsel on legal issues and topics and CMO on clinical development and research initiatives.Focused on cardiovascular, rare disease and Alzheimer's disease -
Head Of Program ManagementCheckmate Pharmaceuticals Jan 2021 - Sep 2022Cambridge, Massachusetts, UsProvide strategic leadership and management direction to ensure the delivery of projects/programs within cost, time, and quality requirements. The Head, Program Management will provide direct supervision, support, training and mentoring. This role has responsibilities for leading an interdisciplinary product team in driving the creation and execution of the global development plan. In this role, the I drive the execution of deliverables across all functional areas supported by the Project Team. Lead oncology programs through the transition from candidate selection through to clinical development. Provide a bridge between research and development organizations to ensure program scientific continuity as well as liaise with regulatory and clinical development to support program advancement commercially. -
Vice President, Enterprise Account LeaderParexel Feb 2019 - Oct 2020Durham, North Carolina, Us• Responsible for a team of Client Relationship Directors for the growth, profitability, and senior level oversight of accounts. Worked closely with project/program management, business operations, process improvements strategy, and finance to ensure client satisfaction and quality delivery. • Leveraged Parexel’s clinical operational business units (early phase, phase II/III and real-world evidence) to increase client business including project management, clinical operations, and recruitment strategies. • Recruited and trained a diverse global pharmaceutical development workforce across multiple therapeutic areas; on-boarded with training global team members by increasing their performance effectiveness of by 25 percent. -
Senior Director, Porfolio ManagementParexel Feb 2014 - Jan 2019Durham, North Carolina, Us● As a client advocate, managed project teams overall deliverables across multiple therapeutic areas and various service lines including project delivery and financial management. Successfully lead multiple global developments in diverse therapeutic areas: oncology, hematology, pulmonary, and pediatric rare diseases with 30+ countries to meet global timelines and within budget (>92%). ● Facilitated the submission strategy product in the several major commercial markets. Recruited, retained, and trained cross functional teams; and worked closely with the clients to ensure goals were met within the clinical plan and budget.● Accountable for the increased strategic development account by adding >$100 M in revenue to organization year over year in collaboration with a team managing complex projects.
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Vice President, OperationsApplied Clinical Intelligence Sep 2012 - Feb 2014Bala Cynwyd, Pa, Us• Provided strategic operational oversight for Clinical Endpoint Adjudication Committees (CEAC), and Independent Data Monitoring Committees for global research and development of various therapeutic area. This included project managers, clinical operations, clinical reviewers, and committee specialists’ departments. • Served as the internal process expert and owner to ensure quality and team/staff enrichment. Directly responsible for organizational enterprise level efficiencies and quality assurance. Worked closely with Commercial and Financial Teams to increase sales and revenue by 30+ percent. -
Sr. Director, Project ManagementApplied Clinical Intelligence Apr 2012 - Sep 2012Bala Cynwyd, Pa, Us• Provided strategic operational oversight for Clinical Endpoint Adjudication Committees (CEAC), and Independent Data Monitoring Committees for global research and development of various therapeutic area. This included project managers, clinical operations, clinical reviewers, and committee specialists’ departments. • Served as the internal process expert and owner to ensure quality and team/staff enrichment. Directly responsible for organizational enterprise level efficiencies and quality assurance. Worked closely with Commercial and Financial Teams to increase sales and revenue by 30+ percent.
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Vice President, Clinical DevelopmentTheorem Clinical Research (Formerly Omnicare Clinical Research) Jul 2009 - Feb 2012Slough, Berkshire Sl1 4Aa, Gb• Served as company’s operations leader liaison across programs/projects, leading operations for clients for successful delivery of product in diverse therapeutic areas: oncology, cardiovascular, neuropsychiatry, pulmonary, rheumatology, and CNS. • Provided operational and strategic oversight for clinical studies including project managers, clinical monitors, commercial, and revenue. Served as internal client champion and advocate to ensure timelines and deliverable were met within specified scope of work and budget. • Directed continuous improvements throughout the global development process; led change management.• Recruited, hired, retained, trained, and mentored a project team (Senior Directors, Project Directors or Project Managers); managed or monitored overall company deliverables to meet revenue and other financial indicators, including change orders, quality services, invoicing, and payments. Increased the number of active projects per quarter thus increasing revenue by 12 percent. -
Vice President, Project ManagementTheorem Clinical Research (Formerly Omnicare Clinical Research) Oct 2007 - Jul 2009Slough, Berkshire Sl1 4Aa, Gb• Provided operational and strategic oversight for clinical studies including project management, clinical monitoring, commercial and revenue. Served as internal client champion and client advocate to ensure timelines and deliverable were met within specified scope of work and budget. • Hired, retained, trained, and mentored a project team (Sr. Project Directors, Project Directors or Project Managers); managed or monitored overall company deliverable to revenue and other financial indicators, including change orders, quality, invoicing and payments. Increased number of active projects per quarter thus increasing revenue.
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Sr. Project Director, Project ManagementTheorem Clinical Research (Formerly Omnicare Clinical Research) Aug 2004 - Sep 2007Slough, Berkshire Sl1 4Aa, Gb• For Phase II-III client accounts, served as primary operations liaison and escalation point of contact for clients. Managed clients and internal teams’ relationships to meet overall expectations for delivery of superior quality and services. Increased overall client satisfaction and sales growth by 35 percent.• Increased number of preferred providers by two cornerstone accounts while increasing overall sales by 25% at existing clients.• Successfully project managed two global Phase III programs (cardiovascular and rheumatology) with 23 countries by meeting timelines and within budget. Helped drive strategy of submission of cardiovascular and rheumatology products in US and five European countries. Awarded “OMNI Award” for exceptional service by CEO.
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Vice President OperationsBdh Clinical Research Aug 1999 - Jul 2004• Led strategic and tactical oversight of commercial and operational clinical development departments including proposal development, operational staff (project managers, CRAs and QA Auditors), and finances. Managed client relationship and helped implement internal process improvements.• Implemented and managed several clients’ internal Total Quality Management systems for overall GCP compliance in Phase II/III.
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Associate Director, Medical AffairsCovance Jul 1997 - Jun 1999Princeton, New Jersey, Us• Managed departmental oversight and in collaboration with assigned team (Assistant Directors, and Project Managers) provided project management services to multiple clients.• Developed and implemented IND and PMS projects (Phase IV). Worked with business development to ensure successful bid models and understanding clients needed. Successfully won largest Phase IV project (>$35M).• Managed client relationships and provided independent non-project client review of processes to ensure maximization of team collaboration while minimizing client cost.• Trained, mentored, and coached 9 direct reports. -
Various PositionsEli Lilly Dec 1989 - Oct 1997Indianapolis, Indiana, UsPositions included: Department Head of Global Information, Department Head of Drug Epidemiology, Global Clinical Coordination, Clinical Research Administrator.• Led strategic and tactical implementation groups of new global medical product information delivery systems. Reorganized department structure to meet both corporate and sales department needs. Increased efficiency by decreasing delivery time to external clients and vendors and increasing message consistency. •Recruited and retained a team of experts; provided training for new global staff members; gained corporate approval for implementation of new job roles within product information and competitive sales marketing •Led implementation of strategic alliances within affiliate organizations and outsourcing groups to provide disease and product information.•Recruited, trained and on-boarded 18 direct reports across two departments -
Sr. Clinical Research AssociatesHoffmann-La Roche Feb 1985 - Nov 1989Switzerland 🇨🇭 , Ch• Provided on-site monitoring of clinical sites and coordinated data collection procedures; monitored three compounds in cardiovascular science. Helped in NDA submission for hypertension• Supervised support staff and helped in training of junior CRAs.
Jerome Bailey Skills
Clinical Development
Clinical Trials
Ctms
Cro
Quality Assurance
Clinical Research
Clinical Monitoring
Leadership
Biotechnology
Drug Development
Team Leadership
Therapeutic Areas
Clinical Pharmacology
Fda
Executive Management
Global Management
Quality Management
Pharmacovigilance
Strategy
Business Planning
Cross Functional Team Leadership
Clinical Trial Management System
Cro Management
21 Cfr Part 11
Cardiology
Project Management
Customer Service
Biopharmaceuticals
Business Development
Clinical Operations
Customer Relations
Crm
U.s. Food And Drug Administration
Clinical Trial Management
Jerome Bailey Education Details
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Rutgers UniversityGeneral
Frequently Asked Questions about Jerome Bailey
What company does Jerome Bailey work for?
Jerome Bailey works for Diversity Health Networx
What is Jerome Bailey's role at the current company?
Jerome Bailey's current role is Co-Founder.
What is Jerome Bailey's email address?
Jerome Bailey's email address is jb****@****rma.com
What is Jerome Bailey's direct phone number?
Jerome Bailey's direct phone number is +150322*****
What schools did Jerome Bailey attend?
Jerome Bailey attended Rutgers University.
What skills is Jerome Bailey known for?
Jerome Bailey has skills like Clinical Development, Clinical Trials, Ctms, Cro, Quality Assurance, Clinical Research, Clinical Monitoring, Leadership, Biotechnology, Drug Development, Team Leadership, Therapeutic Areas.
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