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John Makowski Email & Phone Number
Vice President Clinical Operations Early Development
at
Astellas Pharma
1 work email found
@astellas.com
LinkedIn matched
4 data sources
Profile completeness 100%
Current company
Role
Vice President Clinical Operations Early Development
Location
Truckee, California, United States
Who is John Makowski? Overview
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Quick answer
John Makowski is listed as Vice President Clinical Operations Early Development at Astellas Pharma, based in Truckee, California, United States. AeroLeads shows a work email signal at astellas.com and a matched LinkedIn profile for John Makowski.
John Makowski previously worked as Vice President, Head of Clinical Operations at Astellas Gene Therapies and Executive Director, Clinical Operations at Astellas Gene Therapies. John Makowski holds Bs, Psychology, Chemistry, Health Care Administration from Eastern Michigan University.
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{first}.{last}@astellas.com
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Profile bio
About John Makowski
I am an experienced leader with 25 years of clinical development and operations experience in the pharmaceutical and biotechnology industry. Have provided leadership, strategic planning and execution within several different dynamic clinical operations and clinical development organizations. I have utilized my expertise in study management, program management, system management and business process management across all phases of clinical trials, to provide leadership in clinical trial efficiency and simplification. I look to continue to leverage this broad range of experience to expedite innovative medicines getting to patients as quickly as possible
Listed skills include Protocol Development, Clinical Development, Clinical Trial Management, Edc, and 29 others.
Current workplace
John Makowski's current company
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16 roles
John Makowski work experience
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Vice President Clinical Operations Early Development
Current
Apr 2023 - Present
Vice President, Head Of Clinical Operations
Oct 2021 - Apr 2023
Executive Director, Clinical Operations
Mar 2020 - Oct 2021
Senior Director, Head Of Clinical Operations
Lead Audentes Therapeutics Clinical Operations team in the strategic planning and operational execution of multiple rare disease-gene therapy programs.
Jun 2018 - Mar 2020
Senior Director- Global Head, Development Process Office
Developed, maintained and applied a business process management strategy, approaches & methodologies to drive the ability to create drug development efficiencies Lead and guided a team to pilot and execute efforts to improve key value chain processes within the Product Development areas to accelerate the drug development processes, reduce of operational.
Jun 2016 - Jun 2018
Director- Global Initiative Leader, Trial & Related Information Solutions (Taris)
Designed and executed a global cross enterprise strategic initiative to improve the quality of operation data supporting clinical trial executionImproved clinical trial management system usability, data quality and developed a more effective reporting and analytics of operation data supporting more effective clinical trial execution
Jun 2015 - Jun 2016
Director- Head, Process & Systems Excellence
Drove successful global strategic planning, budgeting and oversight of clinical trial operations systems, business process activities support effective clinical trial executionHad strategic, operational and fiscal oversight of more than 40 staff globally across 3 global sites driving process and system excellence activities for a large global clinical.
Apr 2014 - Jun 2015
Director- Head, Training, Patient Recruitment & Support
Drove successful global strategic planning, budgeting and oversight of clinical operations specific training, patient recruitment support/strategy and system support services across large clinical operation organizationProactive and successful strategic, operational and fiscal oversight of more than 90 staff globally across 6 global sites within training.
Jan 2013 - Apr 2014
Director-Global Head, Training, Process & Systems
Drove successful global strategic planning, budgeting and oversight of clinical operations specific training, business process management and system support services across large clinical operation organizationProactive and successful strategic, operational and fiscal oversight of more than 100 staff globally across 6 global sites within training, process.
Nov 2011 - Jan 2013
Associate Director- Global Head, Clinical Study Systems Implementation
Drove design, strategic direction and operational oversight for a global Clinical Study Systems Implementation group of more and 25 staff within development operations across 5 global sites Accountability to design, improve and maintain business process and system process support across key clinical operations systems supporting clinical study teams and.
Aug 2009 - Nov 2011
Sr. Manager- Clinical Study Management
Managed, developed & mentored multiple levels of Clinical Trial Managers (CTMs) across large portfolio Phase 2 and Phase 3 Oncology development programsDrove effective resource allocation and study execution issue resolution across a large portfolio of Phase 2 and 3 Oncology development programs
Nov 2006 - Aug 2009
Clinical Project Manager- Cns/Pain
Drove successful strategic program management and operation implementation of two small molecule CNS/Pain program (Diabetic Peripheral Neuropathy, Post-Herpetic Neuralgia &Fibromyalgia) within Clinical development organization Served as Clinical Development representative on core development team with strategic stakeholder responsibility across.
Sep 2005 - Nov 2006
Associate Director, Clinical Operations
Provided strategic, operational and fiscal oversight of Clinical Operation Project Support function of more than 20 staff locallyDrove the design, implementation and operational oversight of support organization partnering with large North America monitoring group to ensure effective support across complex therapeutic and study team structure Drove.
Jan 2004 - Oct 2005
Clincial Study Specialist I & Ii- Clincial Study Management & Monitoring
Drove set-up and execution across multiple phase 2 and 3 clinical trials (Metabolic Disease, Women’s Health, Dermatology & CNS)Lead cross functional study management execution teams to support study start up, conduct, close out and regulatory filing activities
Jul 2001 - Dec 2003
Associate Director, Clincial Operations
Statprobe, Inc. (Contract Research Organization)
Drove successful strategic and operation oversight of clinical operations group across 2 sites in North America consisting of 15- 20 staff focused in on monitoring and oversight of phase 3 and 4 studiesPartnered with Director of Clinical Operations and Chief Operating Office to grow and strengthen clinical department through continuous improvement.
Jun 1998 - Jul 2001
2 education records
John Makowski education
Bs, Psychology, Chemistry, Health Care Administration
Eastern Michigan University
Aas, Medical Laboratory Technology
Trocaire College
FAQ
Frequently asked questions about John Makowski
Quick answers generated from the profile data available on this page.
What company does John Makowski work for?
John Makowski works for Astellas Pharma.
What is John Makowski's role at Astellas Pharma?
John Makowski is listed as Vice President Clinical Operations Early Development at Astellas Pharma.
What is John Makowski's email address?
AeroLeads has found 1 work email signal at @astellas.com for John Makowski at Astellas Pharma.
Where is John Makowski based?
John Makowski is based in Truckee, California, United States while working with Astellas Pharma.
What companies has John Makowski worked for?
John Makowski has worked for Astellas Pharma, Astellas Gene Therapies, Genentech, Allergan, Inc., and Pfizer.
How can I contact John Makowski?
You can use AeroLeads to view verified contact signals for John Makowski at Astellas Pharma, including work email, phone, and LinkedIn data when available.
What schools did John Makowski attend?
John Makowski holds Bs, Psychology, Chemistry, Health Care Administration from Eastern Michigan University.
What skills is John Makowski known for?
John Makowski is listed with skills including Protocol Development, Clinical Development, Clinical Trial Management, Edc, Cro, Gcp, Biotechnology, and Clinical Trials.
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