Ritu Namdev Email & Phone Number
@ipsen.com
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Who is Ritu Namdev? Overview
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Ritu Namdev is listed as Global Clinical Development Executive (consultant) based in Cambridge, Massachusetts, United States. AeroLeads shows a work email signal at ipsen.com and a matched LinkedIn profile for Ritu Namdev.
Ritu Namdev previously worked as Head of Clinical Development Operations at Ipsen and VP R&D Operations at Ipsen. Ritu Namdev holds Ipsen Impact Together- Leadership Program from Imd.
Email format at ipsen.com
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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
Listed skills include Clinical Development, Biotechnology, Oncology, Clinical Trials, and 8 others.
Ritu Namdev work experience
A career timeline built from the work history available for this profile.
Global Clinical Development Executive (Consultant)
Global Clinical Development Executive (Consultant)
Global Clinical Development Executive (Consultant)
Role listed
Head Of Clinical Development Operations
Current
Vp R&D Operations
CurrentFounder Prism Llc
CurrentConsulting 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)
Vp R&D Operations
Vp Project Management And Clinical Operations
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.
Director Operational Excellence
Director Of Affinity
Associate Director-Pm (Biotech/Infectious Disease And Vaccines Unit)
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
Clinical Program Manager
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.
Sr. Clinical Project Manager
Leading several phase III-IV postmarketing studies in the Xolair Franchise and leading Clinical Operations Program for NMEs in the Asthma Allergy Francishe
Sr. Clinical Project Manager
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.
Clinical Trial Associate/Senior Scientist/Scientist
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.
Ritu Namdev education
Ipsen Impact Together- Leadership Program
Global Executive Mba
M.Sc, Biochemistry
B.Sc, Microbiology And Biochemistry
Frequently asked questions about Ritu Namdev
Quick answers generated from the profile data available on this page.
What is Ritu Namdev's role at their current company?
Ritu Namdev is listed as Global Clinical Development Executive (consultant).
What is Ritu Namdev's email address?
AeroLeads has found 1 work email signal at @ipsen.com for Ritu Namdev.
Where is Ritu Namdev based?
Ritu Namdev is based in Cambridge, Massachusetts, United States.
What companies has Ritu Namdev worked for?
Ritu Namdev has worked for Ipsen, Prism Llc, Disarm Therapeutics, Summit Plc, and Sanofi-Aventis.
How can I contact Ritu Namdev?
You can use AeroLeads to view verified contact signals for Ritu Namdev, including work email, phone, and LinkedIn data when available.
What schools did Ritu Namdev attend?
Ritu Namdev holds Ipsen Impact Together- Leadership Program from Imd.
What skills is Ritu Namdev known for?
Ritu Namdev is listed with skills including Clinical Development, Biotechnology, Oncology, Clinical Trials, Cross Functional Team Leadership, Ctms, Clinical Research, and Program Management.
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