Ritu Namdev

Ritu Namdev Email and Phone Number

Global Clinical Development Executive (consultant)
Cambridge, MA, US
Ritu Namdev's Location
Cambridge, Massachusetts, United States, United States
Ritu Namdev's Contact Details

Ritu Namdev personal email

n/a
About Ritu Namdev

Senior Pharmaceutical executive with a track record of building and leading development organization, implementing innovative drug development strategies, turning around programs, to deliver on-or-ahead of schedule. Demonstrated ability to shape the vision and know what it takes to execute through the details. This resulted in approval of three new products (VPRIV®, ONFI®, Rituxan sBLA) and advancement of several products in clinical phases.Expert in building and leading teams, identifying root cause of issues, translating complex processes into clear, actionable steps.- Portfolio planning and effective execution - Global Clinical experience in Ph I-IV programs- Broad therapeutic area expertise - Experience at Pharma, Biotech & CRO- Establishing operational excellence - Organizational development Specialties: Oncology, Rheumatoid Arthritis, Asthma and Allergies, CNS, Rare Diseases, Muscular dystrophy, Infectious diseases, Pediatric, Genetic Disorder and Vaccines

Ritu Namdev's Current Company Details

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Global Clinical Development Executive (consultant)
Cambridge, MA, US
Ritu Namdev Work Experience Details
  • Global Clinical Development Executive (Consultant)
    Cambridge, Ma, Us
  • Global Clinical Development Executive (Consultant)
    Cambridge, Ma, Us
  • Global Clinical Development Executive (Consultant)
    Cambridge, Ma, Us
  • Global Clinical Development Executive (Consultant)
    Cambridge, Ma, Us
  • Ipsen
    Ipsen
    Cambridge, Massachusetts, United States
    View
  • Ipsen
    Head Of Clinical Development Operations
    Ipsen Apr 2024 - Present
    Boulogne Billancourt, Fr
    View
  • Ipsen
    Vp R&D Operations
    Ipsen Apr 2020 - Present
    Boulogne Billancourt, Fr
    View
  • Prism Llc
    Founder Prism Llc
    Prism Llc Nov 2018 - Present
    Consulting in Project/Portfolio Management & Clinical Operations:Clinical Operations:- Manage early stage/ virtual companies- Define Clinical Operations strategy, timelines and costs through market launch- Manage clinical programs (Ph1-4 studies) across therapeutic areas through study start-up, conduct and close-out- Review RFPs, evaluate gaps in proposals, clinical trial CRO oversight- Establish GCP, Quality compliance system for Clinical Operations. Prepare teams for state of inspection readiness. - Establish Clinical operations, systems (eTMF), supporting SOPs and process documentsProject/Portfolio Management:- Product Portfolio Management and Analysis- Establish roadmap to critical milestones, go-no-go decision criteria and process for portfolio decision making for programs in discovery, pre-clinical and clinical development- Financial management, capacity planning, budgeting and revenue modeling- Strategic planning, building and leading a cross-functiona developmentl team- CMC project management- Establish Earned Value Management Systems (EVMS)
  • Disarm Therapeutics
    Vp R&D Operations
    Disarm Therapeutics Mar 2019 - Apr 2020
  • Summit Plc
    Vp Project Management And Clinical Operations
    Summit Plc Jun 2014 - Aug 2018
    Miami, Florida, Us
    Build a team of 14 in Program Management and Clinical operations in US & UK and led a cross-functional team to deliver on near and long-term strategy for the Duchenne Muscular (DMD) and Clostridium difficile (C.diff) programs, on time and within budgets. Established Governance for Leadership Team to outline portfolio strategy, timelines /budgets/resources for delivery, risk assessment and decision making. Defined clinical operations strategy, timelines, resources & costs to align with clinical development plans through market launch. Delivered on conduct of clinical trials. Established systems (eTMF (Veeva Vault)), processes, SOPs, ICH/GCP trainings across clinical operations, data management, biometrics, pharmacovigilance, medical to instill excellence in execution and inspection readiness.
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  • Sanofi-Aventis
    Director Operational Excellence
    Sanofi-Aventis Oct 2010 - Jun 2014
    Paris, France, Fr
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  • Healthcare Businesswomen’S Association
    Director Of Affinity
    Healthcare Businesswomen’S Association 2010 - 2012
  • Quintiles
    Associate Director-Pm (Biotech/Infectious Disease And Vaccines Unit)
    Quintiles Nov 2007 - Sep 2010
    Durham, North Carolina, Us
    Led Project Management teams for multiple global studies across 5 continents in multiple indications to ensure all program deliverables are on time and within budget. Key responsibilities include managing client relationships to meet client satisfaction and develop new and repeat business opportunities
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  • Genentech, Inc.
    Clinical Program Manager
    Genentech, Inc. 2006 - 2007
    Managed Clinical Operations prgrams in the Rituxan RA and Apoptosis Franchise in a matrix environment; providing program-specific leadership, clinical trial management expertise and ensuring programs are adequately resourced to meet specific milestones.
  • Genentech
    Sr. Clinical Project Manager
    Genentech 2003 - 2006
    South San Francisco, California, Us
    Leading several phase III-IV postmarketing studies in the Xolair Franchise and leading Clinical Operations Program for NMEs in the Asthma Allergy Francishe
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  • Curagen Corporation
    Sr. Clinical Project Manager
    Curagen Corporation 2001 - 2003
    Us
    Responsible for setting up processes and launching the conduct of the first clinical trial at CurGen. Also led all efforts to set up Biomarker collection for pre-clinical and clinical studies.
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  • Roche Pharmaceuticals
    Clinical Trial Associate/Senior Scientist/Scientist
    Roche Pharmaceuticals 1996 - 2001
    Switzerland 🇨🇭 , Ch
    Held several positions (Process Development, Analytical R&D, DMPK and Toxicology) in the pre-clinical and clinical development learning, delivering on all milestone and contributing to the advancement of several NMEs through development.
    View

Ritu Namdev Skills

Clinical Development Biotechnology Oncology Clinical Trials Cross Functional Team Leadership Ctms Clinical Research Program Management Leadership Vaccines Pharmaceutics Biomarkers

Ritu Namdev Education Details

  • Imd
    Imd
    Ipsen Impact Together- Leadership Program
  • Duke University - The Fuqua School Of Business
    Duke University - The Fuqua School Of Business
    Global Executive Mba
  • University Of Mumbai
    University Of Mumbai
    Biochemistry
  • University Of Mumbai
    University Of Mumbai
    Microbiology And Biochemistry

Frequently Asked Questions about Ritu Namdev

What is Ritu Namdev's role at the current company?

Ritu Namdev's current role is Global Clinical Development Executive (consultant).

What is Ritu Namdev's email address?

Ritu Namdev's email address is ri****@****sen.com

What schools did Ritu Namdev attend?

Ritu Namdev attended Imd, Duke University - The Fuqua School Of Business, University Of Mumbai, University Of Mumbai.

What are some of Ritu Namdev's interests?

Ritu Namdev has interest in Operational Excellence, Gardening And Cooking, Hiking, Corporate Strategy, Operational Innovation.

What skills is Ritu Namdev known for?

Ritu Namdev has skills like Clinical Development, Biotechnology, Oncology, Clinical Trials, Cross Functional Team Leadership, Ctms, Clinical Research, Program Management, Leadership, Vaccines, Pharmaceutics, Biomarkers.

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