Michael Stephens Email and Phone Number
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- 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.
Immunovant
View- Website:
- immunovant.com
- Employees:
- 56
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Sr Dir, Clinical Operations - Global Site ManagementImmunovant Jun 2024 - PresentManchester Area, United KingdomPart 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. -
Snr Director, Study Leads, Country Operations (Haematology)Alexion Pharmaceuticals, Inc. Apr 2022 - May 2024Manchester, UkThe 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 developing clinical monitoring and oversight strategies for all protocols in the TA. Study delivery can be either via in-house monitoring or by use of outsourced partnership. -
Oversight Director (Immunology), Snr Director Project Delivery (General Medicine)Ppd Mar 2021 - Apr 2022Manchester Area, United KingdomProvides 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. -
Managing DirectorMancunium Pharma Consulting Ltd May 2019 - Mar 2021Manchester, United KingdomProviding effective management, quality & timely results, and focussed team or functional leadership to Clinical Operations structures within both Pharma & Biotech.
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Director, Clinical Operations EuRespivant, Inc Jun 2019 - Oct 2020Home Office Based Manchester Uk & Corporate Hq In San DiegoProvided 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.
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Snr Director, Clinical OperationsVital Therapies Inc Nov 2013 - May 2019Home Office Based In Manchester Uk & Corporate Hq In San DiegoDriving 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) for scale up of the Clin Ops function. Worked through various agency GCP inspections of both Sponsor and sites.
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Snr Director, Global Clinical Study DeliveryMedimmune, An Astra Zeneca Company Jan 2011 - Apr 2013Home 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. -
Director, Head International Clinical OperationsGilead Sciences Apr 2007 - Jan 2011Home 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. -
Snr Development Operations Mgr, Head Uk Clinical OperationsAmgen Mar 2003 - Apr 2007Cambridge, England, United KingdomSet 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. -
Snr Clinical Programme Mgr, Amgen Development EuropeAmgen Feb 1999 - 2002Cambridge, England, United KingdomProject management of Phase 2 and 3 clinical studies in Inflammatory diseases including RA, UC and Crohn's Disease. -
Clinical Research Mgr, Uk Clinical OperationsSchering-Plough 1997 - 1999Stevenage, England, United KingdomHead of UK Clinical Operations for UK and Republic of Ireland. -
Snr Clinical Research OfficerMsd 1993 - 1997Hoddesdon, England, United Kingdom
Michael Stephens Skills
Michael Stephens Education Details
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Clinical Immunology Of Hiv Infection -
Clinical Immunology, Toxicolgy & Biochemistry
Frequently Asked Questions about Michael Stephens
What company does Michael Stephens work for?
Michael Stephens works for Immunovant
What is Michael Stephens's role at the current company?
Michael Stephens's current role is Clinical Operations | Pharmaceutical Industry | Effective & Empowering Leadership | Program Delivery Management | CRO Management | Team Building | Clinical Monitoring | Change Management.
What is Michael Stephens's email address?
Michael Stephens's email address is mi****@****ead.com
What is Michael Stephens's direct phone number?
Michael Stephens's direct phone number is +151073*****
What schools did Michael Stephens attend?
Michael Stephens attended University Of Cambridge, Cardiff University / Prifysgol Caerdydd.
What skills is Michael Stephens known for?
Michael Stephens has skills like Clinical Trials, Cro, Edc, Clinical Research, Change Management, Vendor Management, Team Building, Performance Management, Clinical Development, Ctms, Therapeutic Areas, Gcp.
Who are Michael Stephens's colleagues?
Michael Stephens's colleagues are Manika Love, Zachary Saldivar, Margaret Shumel, Scott Stiffler, Brian Goetz, Sarah Mayo, Susanne Macnab.
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Michael Stephens
Hereford -
Michael Stephens
United Kingdom1jpmchase.com
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