Director, Global Clinical Scientist
Current
Aug 2024 - Present
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Rupal Shah Email & Phone Number
Director | Clinical Development Scientist/Clinician (nonMD) | Medical Microbiology | Infectious Disease | Vaccines | Rare Disease
at
BioNTech SE
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✓ Verified Jul 2026
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Profile completeness 86%
Current company
Role
Director | Clinical Development Scientist/Clinician (nonMD) | Medical Microbiology | Infectious Disease | Vaccines | Rare Disease
Location
United States
Who is Rupal Shah? Overview
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Rupal Shah is listed as Director | Clinical Development Scientist/Clinician (nonMD) | Medical Microbiology | Infectious Disease | Vaccines | Rare Disease at BioNTech SE, based in United States. AeroLeads shows a matched LinkedIn profile for Rupal Shah.
Rupal Shah previously worked as Director, Global Clinical Scientist at Biontech Se and Global Program Sr. Clinical Scientist at Moderna. Rupal Shah holds Master Of Science - Ms, Regulatory Affairs from Temple University.
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BioNTech SE
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Profile bio
About Rupal Shah
A seasoned clinical development professional with over 20 years of impactful experience in global clinical development across vaccines, infectious disease and rare disease. I have cultivated a robust skill set as a clinical scientist, medical writer, and clinical program manager. My core competencies include designing and implementing global Phase 1-4 vaccine and rare disease clinical studies, reviewing and interpreting clinical data, preparing and reviewing regulatory and scientific documents, and overseeing the scientific and integrity aspects of clinical programs. My proficiency extends to crafting essential clinical documents, including investigator brochures, protocols, consent forms, clinical study reports, and global regulatory submissions.Thriving in fast-paced, dynamic work environments in cross-functional teams. I've played a pivotal role in the development and delivery of groundbreaking vaccines, including Prevnar, Prevnar13, Trumenba, mRNA COVID-19, and RSV. My unique background in medical microbiology and bacteriology brings diverse perspectives and experiences to the teams I engage with.I am passionate about making a lasting impact in the field of clinical research and development, leveraging my extensive expertise and collaborative spirit to drive successful outcomes in the pursuit of global health solutions.Specialties: Synopsis, protocol and informed consent development, ediary and patient facing material implementation and co-ordination, eCRF design and review, clinical/medical data review, CSR review, process improvement, line management
Current workplace
Rupal Shah's current company
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11 roles
Rupal Shah work experience
A career timeline built from the work history available for this profile.
Mar 2024 - Aug 2024
Direct, Clinical Scientist
Director, Lead Clinical Scientist, Vaccine Clinical Development. Primary PoC for medical and scientific study and project support for multiple, global, Phase 1-4 vaccine clinical studies for vaccine clinical program. Responsible for working collaboratively with the Clinical Lead Physician and Lead Study Clinician Physicians to develop study strategies in support of the clinical plans. Support multiple tasks within the categories of: 1) protocol and study design, strategy, and training, 2) data review and interpretation, 3) study and/or program scientific and integrity oversight, 4) safety review and communication, 5) regulatory document, study report and publication preparation and review, and 6) clinical study implementation oversight, with a critical focus on consistency, quality, data integrity, safety, and alignment with company values.
Jun 2023 - Feb 2024
Clinical Scientist, Senior Manager
Dec 2018 - May 2023
Principal Scientist
Principal Scientist accountable and responsible for planning, execution and operational oversight for clinical and non-clinical serological testing within clinical testing and business operation organization (biomarker operations) supporting various vaccine (Prevnar, Prevnar13, Trumenba, and C. difficile) programs within Pfizer VRD. Accountable for meeting pre-established milestones for clinical trials. Scenario planning and mitigation plans for execution of serological testing using various project management concepts. Lead a team; through goal settings, ongoing assessment and coaching and performance evaluation. Recognize developmental opportunities. Provide scientific guidance to Biofunctional assay team. Analyze biofunctional assay data and evaluate the performance of these assays over time to ensure that assay results are of the highest quality using JMP, excel pivot tables and other excel functions. Lead a team responsible for quality data review to assure data integrity, accuracy, and consistency to support vaccine clinical trials. Cross-functional team collaboration for best practices and solutions, for process improvements to drive consistency and compliance in data reporting, and for the development of data system used within the organization.
Jan 2015 - Dec 2018
Senior Scientist
Jan 2013 - Apr 2015
Senior Research Scientist I
Nov 2010 - Dec 2012
Res Sci I To Res Sci Ii
May 2006 - Nov 2010
Scientist Ii
Feb 2004 - May 2006
Qc Microbiologist
• Processed routine environmental samples to support vaccine development and production in accordance with GMP regulations. • Wrote quarterly reports, SOPs and investigation report as necessary. • Generated manufacturing Investigation Report (MIR) and Laboratory Investigation Report (LIR) using Trackwise system. • Assisted in SOP and report writing, equipment validation and data trending and tracking. • Always worked under Pharmaceutical compliance and cGMP guidelines. Took part in the FDA audit.
Jul 2003 - Feb 2004
Microbiologist
Nov 1998 - Jul 2003
2 education records
Rupal Shah education
Master Of Science - Ms, Regulatory Affairs
Temple University
Bachelor Of Science - Bs, Medical Microbiology And Bacteriology
V. P Science College, V. V. Nagar, India
FAQ
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What company does Rupal Shah work for?
Rupal Shah works for BioNTech SE.
What is Rupal Shah's role at BioNTech SE?
Rupal Shah is listed as Director | Clinical Development Scientist/Clinician (nonMD) | Medical Microbiology | Infectious Disease | Vaccines | Rare Disease at BioNTech SE.
Where is Rupal Shah based?
Rupal Shah is based in United States while working with BioNTech SE.
What companies has Rupal Shah worked for?
Rupal Shah has worked for Biontech Se, Moderna, Pfizer, and Bio Reference Laboratories Inc.
How can I contact Rupal Shah?
You can use AeroLeads to view verified contact signals for Rupal Shah at BioNTech SE, including work email, phone, and LinkedIn data when available.
What schools did Rupal Shah attend?
Rupal Shah holds Master Of Science - Ms, Regulatory Affairs from Temple University.
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