SD.
Physician executive · Clinical safety · Pharmacovigilance

Dr. Sunita Dhar

Global Clinical Safety & Pharmacovigilance Executive
Physician Leader · Drug Development & Benefit-Risk Strategy

Building safer medicines
through science, strategy & people.

01Executive profile

Physician executive and global Clinical Safety leader with 20+ years of biopharmaceutical experience, preceded by 12 years of clinical practice.

Nearly 15 years of progressive leadership at Roche/Genentech, advancing through increasingly senior Safety Science and Medical Director roles to Executive Medical Group Director.

Enterprise-level leader shaping clinical safety strategy, benefit-risk assessment, lifecycle risk management, portfolio governance and regulatory strategy across development and marketed medicines.

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Currently leads a global organization of Safety Strategy Leaders across Basel, Welwyn and the United States, with matrix leadership of 25+ Clinical Safety Scientists.

02Leadership expertise
01

Global Clinical Safety Leadership

02

Development & Marketed Medicines

03

Benefit-Risk Strategy & Governance

04

Portfolio & Lifecycle Safety

05

Executive & Cross-Functional Influence

06

Talent & Succession Development

07

Health Authority Engagement

08

Risk Management & Signal Strategy

09

R&D Transformation

10

AI, Advanced Analytics & Digital Innovation

03Professional experience

Current organization

Roche / Genentech

South San Francisco, CA
2011 — Present
2020 — Present

Executive Medical Group Director, Clinical Safety

Provide global Clinical Safety leadership and enterprise-level strategic direction across a complex portfolio spanning Immunology, Infectious Diseases, Nephrology and Ophthalmology, with oversight of 10+ late-stage and marketed assets from Phase 2 through post-marketing.

Global Clinical Safety Leadership

  • Bring broad therapeutic-area experience spanning Immunology, Infectious Diseases, Nephrology, Ophthalmology (I2O) and Oncology.
  • Lead a global team of Safety Strategy Leaders whose accountability encompasses evolving risk profiles and lifecycle Clinical Safety strategy.
  • Guide lifecycle benefit-risk and safety strategy across 10+ late-stage development and marketed assets with multiple indications.
  • Provide matrix leadership to 25+ Clinical Safety Scientists, including physicians, PharmDs and PhDs.

Executive Governance & Portfolio Strategy

  • Serve on senior executive governance bodies responsible for portfolio-level decisions across four therapeutic areas.
  • Influence decisions involving program progression, development strategy, emerging safety signals, benefit-risk, risk mitigation and Health Authority strategy.
  • Translate complex scientific and safety considerations into clear, actionable communication for executive decision-making.

People & Organizational Leadership

  • Recognized as a people developer, coach and mentor, developing senior Clinical Safety leaders into roles of increasing responsibility.
  • Foster an environment combining scientific rigor, professional autonomy, coaching and deliberate career development.

Enterprise Transformation & Innovation

  • Contribute to Roche Product Development R&D Excellence initiatives designed to transform Product Development.
  • Provide strategic direction around AI, advanced analytics, digital capabilities and predictive approaches that advance Clinical Safety and Pharmacovigilance.

Health Authority & Regulatory Leadership

  • Lead and co-lead Clinical Safety interactions with major Health Authorities, including FDA and EMA.
  • Represent and defend Clinical Safety and benefit-risk positions in regulatory interactions addressing significant safety and labeling considerations.
2011 — 2020

Progressive Leadership at Roche / Genentech

Advanced through increasingly senior Safety Science and Medical Director roles across Oncology, building extensive experience in cross-functional development governance, benefit-risk assessment and risk-management strategy.

Selected appointments

  • Senior Group Medical Director, Safety Science Oncology · 2019–2020
  • Group Medical Director, Safety Science Oncology · 2017–2019
  • Senior Safety Science Leader, Oncology · 2014–2017
  • Safety Science Leader, Oncology · 2012–2014
  • Senior Safety Scientist, Oncology · 2011–2012
2007 — 2011

Director, Drug Safety / Head of Drug Safety

Nektar Therapeutics · San Francisco, CA

Led the Drug Safety department and chaired the Nektar Safety Review Committee, providing corporate-level safety oversight across the clinical-development portfolio.

Impact

  • Built the Drug Safety function from a CRO-based service into a fully functional internal Safety Science organization supporting four development molecules.
  • Provided safety oversight across five Phase 1, three Phase 2 and the initiation of two large Phase 3 studies.
  • Led Drug Safety due diligence supporting the successful partnering of a proprietary program that subsequently received market approval.
  • Directed benefit-risk assessment, signal detection and signal-management strategy across the clinical portfolio.
  • Led implementation of ARISg adverse-event management and agXchange electronic safety-submission platforms.
2005 — 2006

Senior Clinical Safety Monitor

Abbott Vascular / Guidant · Santa Clara, CA

Led Clinical Safety activities for advanced drug-device combination studies in interventional cardiology, including serious adverse-event assessment and periodic safety reporting.

04Earlier experience
2004–2005Clinical Safety / Drug Safety ConsultantClinimetrics Research Associates
2003–2004Senior Research AssociateMatthias Rath Inc.
1993–2002Medical OfficerMinistry of Health, Oman
1991–1993Clinical Research OfficerAll India Institute of Medical Sciences, New Delhi
1987–1991Clinical PracticeIndia
05Leadership & education

UC Davis Graduate School of Management

Biotechnology Industry Immersion Advisory Board

2022 — Present

Advising the MBA Biotechnology Industry Immersion Program, bringing contemporary biotechnology-industry perspectives into management education and mentoring emerging biotechnology leaders.

Education & credentials

M.B.B.S., Medicine

1987 · Government Medical College, University of Kashmir, India

Permanent Registration and Licensure · Medical Council of India