Michael Stephens

Michael Stephens Email and Phone Number

Clinical Operations | Pharmaceutical Industry | Effective & Empowering Leadership | Program Delivery Management | CRO Management | Team Building | Clinical Monitoring | Change Management @ Immunovant
new york, united states
Michael Stephens's Location
Manchester Area, United Kingdom, United Kingdom
Michael Stephens's Contact Details

Michael Stephens work email

Michael Stephens personal email

n/a
About Michael Stephens

- 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.

Michael Stephens's Current Company Details
Immunovant

Immunovant

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Clinical Operations | Pharmaceutical Industry | Effective & Empowering Leadership | Program Delivery Management | CRO Management | Team Building | Clinical Monitoring | Change Management
new york, united states
Website:
immunovant.com
Employees:
56
Michael Stephens Work Experience Details
  • Immunovant
    Sr Dir, Clinical Operations - Global Site Management
    Immunovant Jun 2024 - Present
    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.
  • Alexion Pharmaceuticals, Inc.
    Snr Director, Study Leads, Country Operations (Haematology)
    Alexion Pharmaceuticals, Inc. Apr 2022 - May 2024
    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 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.
  • Ppd
    Oversight Director (Immunology), Snr Director Project Delivery (General Medicine)
    Ppd Mar 2021 - Apr 2022
    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.
  • Mancunium Pharma Consulting Ltd
    Managing Director
    Mancunium Pharma Consulting Ltd May 2019 - Mar 2021
    Manchester, United Kingdom
    Providing effective management, quality & timely results, and focussed team or functional leadership to Clinical Operations structures within both Pharma & Biotech.
  • Respivant, Inc
    Director, Clinical Operations Eu
    Respivant, Inc Jun 2019 - Oct 2020
    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.
  • Vital Therapies Inc
    Snr Director, Clinical Operations
    Vital Therapies Inc Nov 2013 - May 2019
    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) for scale up of the Clin Ops function. Worked through various agency GCP inspections of both Sponsor and sites.
  • Medimmune, An Astra Zeneca Company
    Snr Director, Global Clinical Study Delivery
    Medimmune, An Astra Zeneca Company Jan 2011 - Apr 2013
    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.
  • Gilead Sciences
    Director, Head International Clinical Operations
    Gilead Sciences Apr 2007 - Jan 2011
    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.
  • Amgen
    Snr Development Operations Mgr, Head Uk Clinical Operations
    Amgen Mar 2003 - Apr 2007
    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.
  • Amgen
    Snr Clinical Programme Mgr, Amgen Development Europe
    Amgen Feb 1999 - 2002
    Cambridge, England, United Kingdom
    Project management of Phase 2 and 3 clinical studies in Inflammatory diseases including RA, UC and Crohn's Disease.
  • Schering-Plough
    Clinical Research Mgr, Uk Clinical Operations
    Schering-Plough 1997 - 1999
    Stevenage, England, United Kingdom
    Head of UK Clinical Operations for UK and Republic of Ireland.
  • Msd
    Snr Clinical Research Officer
    Msd 1993 - 1997
    Hoddesdon, England, United Kingdom

Michael Stephens Skills

Clinical Trials Cro Edc Clinical Research Change Management Vendor Management Team Building Performance Management Clinical Development Ctms Therapeutic Areas Gcp Oncology Regulatory Submissions Pharmaceutical Industry Rheumatology Hematology Infectious Diseases Sop Clinical Monitoring Ich Gcp Immunology Biotechnology Endocrinology Clinical Operations Gastroenterology Regulatory Affairs 21 Cfr Part 11 Biopharmaceuticals Vaccines Drug Development Protocol Fda Clinical Data Management Medical Writing Pharmacovigilance Clinical Study Design Medical Affairs Team Management Cross Functional Team Leadership Virology Lifesciences Ind Life Sciences Cro Management Good Clinical Practice Electronic Data Capture U.s. Food And Drug Administration Standard Operating Procedure

Michael Stephens Education Details

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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