Summary
Overview
Work History
Education
Skills
Review Activities
Selected Publications
Certification And Professional Development
Personal Information
Timeline
Generic

Roopali Gandhi

Sharon

Summary

Accomplished Global Medical Director at Sanofi with expertise in medical strategy development and KOL engagement. Proven track record in accelerating clinical programs and fostering cross-functional collaboration. Adept at biomarker research and mentoring future medical leaders, delivering impactful results in neurology and immunology.

Overview

21
21
years of professional experience

Work History

Global Medical Director

Sanofi
03.2021 - Current
  • Developed and executed comprehensive medical strategies for neurology pipeline assets across multiple therapeutic areas (neuromuscular, neurodegenerative and peripheral neuropathy)
  • Aligned medical strategies with overall business objectives in collaboration with Global Project Heads, New Product Planning leads, Market Access, and HEVA partners
  • Designed integrated evidence generation plans addressing critical unmet needs, ensuring alignment with product value proposition
  • Led development of comprehensive Early Access Programs (EAP) for RIPK1 in ALS, ensuring ethical and compliant patient access prior to commercial availability
  • Accelerated phase 2 to phase 3 program transitions by leveraging KOL insights to provide critical medical perspectives to influence governance decisions, optimize protocols and enhance patient enrollment strategies
  • Forged strategic partnership with commercial team to develop scientifically grounded brand plans
  • Co-led differentiation workshops to strategically position product in competitive markets
  • Provided medical support for positioning workshops to develop compelling product narratives
  • Orchestrated strategic advisory boards to capture KOL insights on unmet needs, competitive landscape, and positioning strategies
  • Accelerated clinical development programs through enhanced site recruitment strategies
  • Established and maintained strategic relationships with key opinion leaders (KOLs)
  • Delivered comprehensive internal medical training on disease states and mechanism of action
  • Led development of scientific presentations and chaired symposia at major medical conferences
  • Created tailored resources and provided strategic guidance to regional medical teams
  • Collaborated extensively with Clinical Development, R&D, and cross-functional teams
  • Member of Medical Mentorship Program initiatives, developing future medical leaders

Medical Director / Associate Medical Director

Sanofi Genzyme
01.2017 - 01.2021
  • Architected and executed comprehensive Medical/Brand plans for pipeline assets and marketed products
  • Led cross-functional immunology expertise team, developing sophisticated educational resources
  • Provided Medical support for industry-sponsored symposia at major neurology congresses
  • Designed and facilitated targeted advisory boards on emerging science and product positioning
  • Conducted expert review of promotional and training materials, ensuring scientific accuracy
  • Provided Medical support for investigator meetings to enhance site engagement
  • Mentored pharmacy post-doctoral fellows, developing next-generation medical affairs talent
  • Implemented innovative activities for the Medical Mentorship Program
  • Collaborated with publication teams to identify evidence gaps and prioritize data generation
  • Partnered with Medical Communications to create scientifically rigorous educational resources
  • Guided field medical teams in KOL engagement strategies and insight generation
  • Facilitated educational roundtables with healthcare providers on multiple sclerosis pathophysiology

Assistant Professor of Neurology & Head of MS Biomarker Group

Brigham and Women's Hospital, Harvard Medical School
01.2013 - 01.2017
  • Expertise in biomarkers development including identification of diagnostic, predictive, and drug response markers in Multiple Sclerosis (MS)
  • Developed, managed and supervised projects to understand the disease and mechanism of action for current MS therapies
  • Demonstrated ability to work and lead a cross-functional team
  • Established and successfully managed multiple collaborations with academic labs and biopharmaceutical companies (Novartis, EMD Serono, Biogen, and Genzyme) and CROs
  • Mentored and supervised full time employees and students
  • Served as a reviewer for multiple Neurology and Immunology journals
  • Consistently achieved program milestones ahead of schedules and within project budget
  • Delivered lectures as invited speaker at national and international conferences (including AAN and ECTRIMS)
  • Obtained funding for research program and published more than 25 peer-reviewed manuscripts, review articles and book chapters

Instructor in Neurology & Manager of Clinical Immunology Laboratory

Brigham and Women's Hospital
01.2010 - 01.2013
  • Initiated and spearheaded a research project to study the role of gut-microbiome in Multiple sclerosis
  • Determine Immune profile in blood samples from phase I clinical trial of oral anti-CD3 therapy in Diabetic patients
  • Initiated and supervised a research project to study the role of miRNA as biomarker for MS (disease diagnosis, prognosis, treatment response and disability)
  • Established and managed a project to identify immune cell based biomarkers for Gilenya treatment (funded by Novartis)
  • Managed and supervised research associates to create bio-repository for patient's samples
  • Published 6 peer-reviewed manuscripts

Postdoctoral Fellow

Brigham and Women's Hospital
01.2004 - 01.2010
  • Identified signaling mechanism that induces type 1 regulatory T cell-like and Foxp3(+) regulatory T cells
  • Induced oral tolerance in animal models
  • Identified and characterized novel human regulatory T cell subset
  • Determined the mechanism by which human dendritic cell subset inhibits T cell activation
  • Determined the role of IL-27 in immune-regulatory function of human NK cells

Education

Ph.D. - Immunology

National Institute of Immunology/ JMI
New Delhi, India
01.2004

M.Sc. - Fermentation and Microbial Technology

Guru Nanak Dev University
Punjab, India
01.1998

B.Sc. - Microbiology

Delhi University
New Delhi, India
01.1996

Skills

  • Medical strategy development and execution
  • Cross-functional leadership and collaboration
  • KOL relationship management and engagement
  • Scientific platform and narrative development
  • Biomarker research and translational medicine
  • Mentorship and talent development

Review Activities

MS Australian Research Society - Ad hoc Reviewer, NMSS - Ad hoc Reviewer, Clinical Immunology - Reviewer, Annals of Neurology - Reviewer, Neuromolecular Medicine - Reviewer, Neurological Research and Therapy - Editorial Board Member, Neuroimmunology and Neuroinflammation - Reviewer, Neurology and Neuroscience - Editorial Board Member, Multiple Sclerosis - Reviewer, American Academy of Neurology - Abstract Review Committee, NIH, Extracellular RNA consortium - Abstract Review Committee

Selected Publications

  • Biomarkers in Multiple Sclerosis, Paul A, Comabella M, Gandhi R., Cold Spring Harb Perspect Med., 03/01/19, 9, 3, a029058
  • Alterations of the human gut microbiome in multiple sclerosis, Jangi S, Gandhi R, et al., Nat Commun., 06/28/16, 7, 12015, Equal first author
  • Activation of the aryl hydrocarbon receptor induces human type 1 regulatory T cell-like and Foxp3(+) regulatory T cells, Gandhi R, et al., Nature Immunology., 09/01/10, 11, 9, 846-53
  • Cutting edge: human latency-associated peptide+ T cells: a novel regulatory T cell subset, Gandhi R, et al., Journal of Immunology, 05/01/10, 84, 9, 4620-4
  • Circulating microRNAs as biomarkers for disease staging in multiple sclerosis, Gandhi R, et al., Annals of Neurology., 06/07/13, 73, 6, 729-40

Certification And Professional Development

  • Harvard Catalyst Leadership Course, Harvard Medical School, Boston, MA, 2015
  • Women's Leadership Program, Brigham and Women's Hospital, Boston, MA, 2015
  • BWH Leadership Program, Brigham and Women's Hospital, Boston, MA, 2014
  • Clinical Research Certificate, Boston College, Chestnut Hill, MA, 2008

Personal Information

Citizenship: US citizen

Timeline

Global Medical Director

Sanofi
03.2021 - Current

Medical Director / Associate Medical Director

Sanofi Genzyme
01.2017 - 01.2021

Assistant Professor of Neurology & Head of MS Biomarker Group

Brigham and Women's Hospital, Harvard Medical School
01.2013 - 01.2017

Instructor in Neurology & Manager of Clinical Immunology Laboratory

Brigham and Women's Hospital
01.2010 - 01.2013

Postdoctoral Fellow

Brigham and Women's Hospital
01.2004 - 01.2010

Ph.D. - Immunology

National Institute of Immunology/ JMI

M.Sc. - Fermentation and Microbial Technology

Guru Nanak Dev University

B.Sc. - Microbiology

Delhi University
Roopali Gandhi
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