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@gilead.com
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Michael Stephens is listed as Clinical Operations | Pharmaceutical Industry | Effective & Empowering Leadership | Program Delivery Management | CRO Management | Team Building | Clinical Monitoring | Change Management at Immunovant, a company with 56 employees, based in Manchester Area, United Kingdom, United Kingdom. AeroLeads shows a work email signal at gilead.com, phone signal with area code 510, 858, and a matched LinkedIn profile for Michael Stephens.
Michael Stephens previously worked as Sr Dir, Clinical Operations - Global Site Management at Immunovant and Snr Director, Study Leads, Country Operations (Haematology) at Alexion Pharmaceuticals, Inc.. Michael Stephens holds Phd (Cantab), Clinical Immunology Of Hiv Infection from University Of Cambridge.
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AeroLeads found 1 current-domain work email signal for Michael Stephens. Compare company email patterns before reaching out.
- More than 25 years dynamic management experience of effectively leading clinical research operations projects, teams & people in UK, US, EU, & Australia.- Successful experience of formal meetings with Regulatory Agencies (EMA, FDA, MHRA, PEI, AEMPs and others).- I have delivered both strategic & tactical operational roles within Remote home office, Corporate, Regional or Affiliate settings, including WFH in a full home office set-up for the past 9 years.- Achieved positive results in clinical research through effective vendor management, to meet recruitment targets, reporting timelines, and budget limitations whilst maintaining a state of Inspection Readiness.- Leadership of Clinical Field Operations teams in the execution of clinical trials using in-house, out-sourced, and hybrid clinical teams, including use of an FSP for US site management and monitoring, and the use of SMOs.- I have driven significant change management process initiatives to enhance departmental effectiveness, efficiency & quality.- Experience of working in collaboration with Regulatory Affairs colleagues with both the EMA & FDA on the clinical component of BLA/MAA/NDA filings.Goal: To be the best that I can be...Specialties: Clinical Research deliverables to time, quality & budget.Team building & performance management. Organization building and change management. Resource allocation, clinical trial budget forecasting and management. Regulatory inspection readiness and Agency GCP Inspections. CRO/Sponsor relationship management. Clinical site relationship management. Vendor management of IVRS, central laboratories & EDC.On a personal note, my main interests reflect my team player mentality in that they are mainly of a sporting nature. Football, rugby union, cricket and gym training are my favourites, whenever time permits. I am a season ticket holder at my beloved Old Trafford. I also enjoy travel, films, and cooking.
Listed skills include Clinical Trials, Cro, Edc, Clinical Research, and 45 others.
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Manchester Area, United Kingdom
Part of the Global Site Management LT responsible for driving clinical site oversight and relationship management ex-US. The role also partners with Clinical Operations/Clinical Development/Medical Affairs/CRO to define strategy for study country footprint and site selection.
Manchester, UK
The Director SLCO leads a TA aligned team of SLCOs who are accountable for monitoring and site management oversight globally for assigned studies. The DSLCO is a key contributor to the strategy and overall direction of operational activities related to key study milestone planning, country footprint allocation, recruitment modelling/support strategies, and.
Manchester Area, United Kingdom
Provides management and mentorship support for Project Managers and global team members assigned to Immunology therapeutic area projects. Leadership and strategy for ongoing studies, support development of new proposals and BDMs, country mix, and key operational and financial drivers to deliver projects/programmes to time, quality & budget.
Manchester, United Kingdom
Providing effective management, quality & timely results, and focussed team or functional leadership to Clinical Operations structures within both Pharma & Biotech.
Home Office Based Manchester UK & Corporate HQ In San Diego
Provided direction and oversight for the EU component of a global Ph IIb study in an orphan indication, working in a hybrid outsourced/in-house delivery model. I built an EU team of Clinical Site Liaison Managers and delivered 30+ EU initiated sites to plan and then supported aggressive enrolment targets.
Home Office Based In Manchester UK & Corporate HQ In San Diego
Driving the Clinical Operations component of a Phase 3 programme developing a human cell based bio-artificial liver support system (ELAD System) in acute liver failure. Led a team of Clinical Liaison Managers across EU clinical sites to support clinical site deliverables in an outsourced setting. Worked with the VP Clin Ops to plan (tactical and strategic).
Home Office Based In Manchester UK, And Gaithersburg MD HQ.
Leading and directing a global team of 90+ CPMs, CRAs & CSAs to deliver clinical trial execution across all phases, TAs and geographies to time, quality and budget.
Home Office Based Manchester UK, And Cambridge Regional office.
Created a harmonized a Medical Affairs Clinical Operations team to deliver late stage clinical research across the EU & Australian affiliate offices. The clinical studies were used either to support strategic label extensions or tactical flagship publications.
Cambridge, England, United Kingdom
Set direction and provided management support for the affiliate's Clinical Operations team of 25 PMs/CRAs/CTAs delivering the UK/Ireland component of pan-EU or global clinical trials across all TAs and phases.
Cambridge, England, United Kingdom
Project management of Phase 2 and 3 clinical studies in Inflammatory diseases including RA, UC and Crohn's Disease.
Stevenage, England, United Kingdom
Head of UK Clinical Operations for UK and Republic of Ireland.
Other employees you can reach at immunovant.com. View company contacts for 56 employees →
Annetta Beauregard
Colleague at ImmunovantWashington DC-Baltimore Area, United States
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Shasha Chen
Colleague at ImmunovantLos Angeles, California, United States, United States
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Angelica Griffin, Pmp
Colleague at ImmunovantSunnyvale, California, United States, United States
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Tom Forman
Colleague at ImmunovantIndianapolis, Indiana, United States, United States
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Breanna Pratt
Colleague at ImmunovantAsheville, North Carolina, United States, United States
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Farhad Rahaman
Colleague at ImmunovantNew York City Metropolitan Area, United States
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Gabriella Stefanini
Colleague at ImmunovantItaly, Italy
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Brian Goetz
Colleague at ImmunovantGreater Pittsburgh Region, United States
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Victoria Butners
Colleague at ImmunovantRaleigh-Durham-Chapel Hill Area, United States
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Kathy Duffey
Colleague at ImmunovantNew York City Metropolitan Area, United States
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Quick answers generated from the profile data available on this page.
Michael Stephens works for Immunovant.
Michael Stephens is listed as Clinical Operations | Pharmaceutical Industry | Effective & Empowering Leadership | Program Delivery Management | CRO Management | Team Building | Clinical Monitoring | Change Management at Immunovant.
AeroLeads has found 1 work email signal at @gilead.com for Michael Stephens at Immunovant.
AeroLeads has found 3 phone signal(s) with area code 510, 858 for Michael Stephens at Immunovant.
Michael Stephens is based in Manchester Area, United Kingdom, United Kingdom while working with Immunovant.
Michael Stephens has worked for Immunovant, Alexion Pharmaceuticals, Inc., Ppd, Mancunium Pharma Consulting Ltd, and Respivant, Inc.
Michael Stephens's colleagues at Immunovant include Annetta Beauregard, Shasha Chen, Angelica Griffin, Pmp, Tom Forman, and Breanna Pratt.
You can use AeroLeads to view verified contact signals for Michael Stephens at Immunovant, including work email, phone, and LinkedIn data when available.
Michael Stephens holds Phd (Cantab), Clinical Immunology Of Hiv Infection from University Of Cambridge.
Michael Stephens is listed with skills including Clinical Trials, Cro, Edc, Clinical Research, Change Management, Vendor Management, Team Building, and Performance Management.
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