Raman Sehgal
New Delhi
Summary
A strategic, collaborative leader with two decades of experience in the clinical research and drug development industry. Expert in P&L management, setting operational strategy, and driving high-quality trial execution from early phase to Phase 4 studies across CROs and sponsors. Proven track record in resource management, executing cost-saving measures, and ensuring ICH/GCP compliance, while successfully hosting numerous regulatory inspections (EMA and DCGI) with zero critical findings.
Overview
20
20
years of professional experience
Work History
General Manager
Medanta - The Medicity
02.2024 - Current
- Drove Strategic Growth and Financial Accountability: Established the clinical research division's long-term vision, securing strategic partnerships with major Sponsors and CROs (e.g., Pfizer, BMS, AZ, Fortrea, Parexel etc.) to increase the volume and complexity of the research pipeline. Developed Research Support Programs (RSP) to incentivize research and increase investigator participation and foster innovation. Held complete financial ownership of the portfolio, including P&L oversight and timely revenue realization.
- Accelerated Operational Timelines and Enhanced Quality Governance: Implemented critical process improvements that significantly reduced study start-up timelines by nearly 50% by fast-tracking CTAs. Successfully managed a diverse Phase I-IV portfolio while establishing and maintaining institutional ICH/GCP compliance and quality governance.
- Ensured Ethical and Regulatory Integrity: Served as an IRB/EC member and ensured strict adherence to global compliance standards throughout all phases of the trial lifecycle. Managed and mentored direct reports.
Director and Head Clinical Operations
PFC Pharma Focus India Pvt. Ltd.
05.2017 - 02.2024
- Drove performance improvements and operational efficiencies through innovative strategies.
- Managed financial forecasts and program performance to achieve departmental targets.
- Served as primary contact for customers, providing project status updates to executive leadership.
- Supported sales processes by preparing proposals and participating in bid defense meetings.
- Focused on indications including Relapsed/Refractory Multiple Myeloma, DLBCL, and Corneal Defects of the Eye.
- Contributed to management of projects related to Adenovirus Conjunctivitis and Head & Neck Squamous Cell Carcinoma.
- Oversaw initiatives concerning Uveitis, COVID Vaccine, and Esophageal Carcinoma.
Senior Project Manager
Novartis Healthcare Pvt. Ltd.
06.2016 - 10.2016
- Developed and implemented project plans aligned with organizational strategic goals.
- Managed project timelines, budgets, and resources throughout project lifecycle effectively.
- Facilitated stakeholder meetings to gather requirements and ensure alignment on projects.
- Analyzed project risks and devised proactive mitigation strategies to minimize impact.
- Mentored junior project managers, enhancing team performance and skills development.
Senior Manager
Quintiles Research India Pvt. Ltd. (now IQVIA)
10.2009 - 05.2016
- Joined as Assistant Manager in Oct 2009; Promoted to Associate Manager in 2011, Manager in 2013, and Sr. Manager in 2015.
- Key Accomplishments: Supported clinical development of first Multiple Myeloma drug in the second-line setting, since 2016. Drug approved by USFDA under accelerated approval pathway. Study results presented at American Society of Hematology in Dec 2020, annual meetings of ASCO and European Hematology Association, June 2021. Pivotal Phase 3 study results published in The Lancet in Nov 2020. Forms the basis for the USFDA approval.
- Novel anti-cancer drug for DLBCL granted conditional marketing authorization by the European Commission in Mar 2021. Results published in The Lancet Haematology, July 2020.
- Study drug combinations added to Clinical Practice Guidelines in Oncology by National Comprehensive Cancer Network in Dec 2020.
- Successful eTMF inspection in Jan 2022 by EMA for a Phase 3 Multiple Myeloma study. No critical / major findings.
- Successful sponsor site audit for an oncology study (Phase 2 Head & Neck Squamous Cell Carcinoma). No critical / major findings. Auditor appreciated the overall site management by CRA.
- Positive Topline Phase 2 Data presented to USFDA in Jan 2023 for treatment of Persistent Corneal Epithelial Defect.
- Lead the Clinical Trial Team to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures.
- Accountable for all internal meetings related to clinical trial execution and operational excellence.
- Develop, manage and track trial budget with finance and sponsor representative.
- Indications worked – Cardiovascular, Renal & Metabolism.
- Led clinical monitoring teams for 2 Quintiles regional offices in India (Delhi and Ahmedabad) apart from overseeing clinical operations in Bangladesh & Sri Lanka.
- Responsible for interviewing, on-boarding and training of new recruits including managing the CRA School program. Ensuring clinical staff gains the necessary skills to perform their respective job responsibilities.
- As a member of Quintiles India leadership team, played a crucial role in formulating strategic goals and ensuring operational excellence in alignment with corporate priorities.
- Complete ownership of direct reports. Line Manager for a large group of Principal CRAs / CTLs, Sr. CRAs, CRAs, CTAs.
- Drive employee engagement, track utilization metrics, plan yearly goals and conduct annual performance appraisals and salary planning.
- Manage the quality of clinical project work through review and evaluation PDQ (Productivity, Delivery, and Quality) indicators.
- Identify quality risks and issues and execute appropriate corrective action plans to prevent or correct deficiencies in the performance of staff.
- Successfully led a regional re-monitoring assignment (on secondment) in Philippines for a top biopharmaceutical MNC. Appreciated by sponsor for completing the CAPA activities 15 days before the timelines and saving significant cost.
- Managed large FSP accounts for Eli Lilly and Biogen Idec. I was responsible for all project/program deliverables including the transition of studies from other CROs to Quintiles.
- Key thought leader in departmental quality and process improvement initiatives.
- Responsible for several line management initiatives within the organization, all aimed at improving project delivery, quality and employee engagement and retention.
- Have significant experience in hosting GCP regulatory inspections. Hosted 2 EMA inspections; submitted an effective CAPA before timelines which resulted in downgrading of MAJOR findings and eventually marketing authorization.
- Indications worked – Cardiology, Neurology, Oncology, Gastroenterology, Blood Disorders, Rotavirus Vaccine, Dengue Vaccine, Parkinson’s Disease, COPD etc.
Sr. Clinical Research Associate
ICON Clinical Research
07.2008 - 10.2009
- Monitoring Phase 3 protocols at multiple sites in India.
- Identifying new sites, conducting site selection visits, making regulatory submissions, negotiating financial contracts between the Sponsor and investigators, preparing IP release.
- Site initiation visits.
- Responsible for planning & managing the activities and reviewing the visit reports of the CRAs. Responsible for coordinating with sites and finalizing Informed Consent Forms and other study documents for the study.
- Ensure high performance and efficiency of the clinical team through co-monitoring/accompanied site visits and ongoing mentoring of CRA team.
- Indications worked – Vaccines and Neurology.
Sr. Clinical Research Associate
GVK BIO
04.2007 - 07.2008
- Joined as Clinical Research Associate in Apr 2007.
- Accountable for overseeing the clinical trial process at the study/site from site training to site close out.
- Ensures timely delivery of high quality, robust and reliable data.
- Clinical monitoring and supporting CPM as a Lead CRA.
- Ensure that clinical research studies are conducted in accordance with the protocol, SOPs, ICH-GCP, and applicable regulatory requirements.
- Indications worked – Immunology, Neuro-Psychiatry and Oncology.
Clinical Research Associate
ICON Clinical Research
10.2006 - 04.2007
- To perform pre-trial, trial, and post-trial activities as per GCP/SOPs.
- Indications worked – Endocrinology (T2DM) and Neurology.
Executive - Clinical Research
Panacea Biotec
11.2005 - 09.2006
- Conduct feasibility and site selection.
- Site initiation visits, onsite monitoring activities, and closeout visits.
- Medical writing (protocol, IB, CSR, etc.). One of the few CRAs who published results of a Phase 2 study in an international journal.
- Assisting in preparation of regulatory dossiers, CRO selection.
- Indication worked – Monovalent, Tetravalent and Pentavalent Vaccines, musclo-skeletal pain management and anti-infectives.
Education
Master of Science - Pharmacology
All India Institute of Medical Sciences
New Delhi, India01-2005
Bachelor of Pharmacy -
Jamia Hamdard University
New Delhi, India01-2003
Diploma in Pharmacy -
Jamia Hamdard University
New Delhi, India01-1999
Skills
- Project and people management
- Cross-cultural leadership
- Conflict resolution
- Problem solving
- Vendor management
- Collaboration and partnership
- Effective communication
- Active listening
- Risk management
- Strategy execution
- Coaching and mentoring
- Inspection readiness
- Training development
- Change management
- Trust building
- Budget forecasting
- Inclusive excellence
- Emotional intelligence
- Technical writing
- E-clinical systems expertise
Accomplishments
• Received ‘Certificate of Merit’ for being the only participant to score a perfect 100% in GCP workshop conducted by CDSA & Biotech Consortium India Limited (BCIL) in Jan 2020 for National Biopharma Mission (NBM), Dept. of Biotechnology, Govt. of India.
• More than 30+ ‘Work Worth Doing Awards’ (WWDs) and ‘Value in Practice’ (VIP) awards in Quintiles for leadership, customer centricity, displaying teamwork and taking quality initiatives. (Most at a managerial level)
• VIP award from the Executive Management of Quintiles after a successful EMA inspection and before time CAPA submission (2016).
• Provided safety data in response to the query generated by the regulatory office/MOH which subsequently led to the resumption of study in India. ‘Employee of the year’ at GVK Biosciences, October 2007.
• Certificate of Recognition for outstanding achievement from Wyeth in 2007 (now Pfizer).
• Certificate of Recognition for Customer Centricity from Mr. D. S. Brar, Chairman, GVK Biosciences & ex-CEO and MD, Ranbaxy Research Laboratories.
• Moderates the largest group of Clinical Research Professionals on LinkedIn. Recently awarded for managing one of the most engaging groups. Transformed Indian Society of Clinical Research from a dormant account to ~ 21K active members as of Nov 2023.
• More than 30+ ‘Work Worth Doing Awards’ (WWDs) and ‘Value in Practice’ (VIP) awards in Quintiles for leadership, customer centricity, displaying teamwork and taking quality initiatives. (Most at a managerial level)
• VIP award from the Executive Management of Quintiles after a successful EMA inspection and before time CAPA submission (2016).
• Provided safety data in response to the query generated by the regulatory office/MOH which subsequently led to the resumption of study in India. ‘Employee of the year’ at GVK Biosciences, October 2007.
• Certificate of Recognition for outstanding achievement from Wyeth in 2007 (now Pfizer).
• Certificate of Recognition for Customer Centricity from Mr. D. S. Brar, Chairman, GVK Biosciences & ex-CEO and MD, Ranbaxy Research Laboratories.
• Moderates the largest group of Clinical Research Professionals on LinkedIn. Recently awarded for managing one of the most engaging groups. Transformed Indian Society of Clinical Research from a dormant account to ~ 21K active members as of Nov 2023.
Affiliations
- Life Member Indian Society of Clinical Research (ISCR). Active member of the PV council of ISCR.
- Served on the editorial board of ‘The Pharma Review’ from 2004 - 2020.
Publications
- Reinventing Patient Recruitment - Achieving accelerated clinical endpoints through a revolutionary patient recruitment model. Jeff Parke and Sehgal R. Pharma Focus Asia 2023. Issue 50, 48-51.
- A phase II randomized controlled trial to evaluate the safety and efficacy of Praneem polyherbal vaginal tablets compared with betadine vaginal pessary in women with symptoms of abnormal vaginal discharge. Sehgal R, Talwar GP, Salhan S, Tripathi V, Chatterjee A, Kumar G. Asia Pac J Public Health 2009 Oct;21(4):461-8.
- Calotropis procera latex-induced inflammatory hyperalgesia - effect of anti-inflammatory drugs. Sehgal R, Kumar VL. Mediators of Inflammation 2005 (4), 216-220.
- Antioxidant and protective effect of latex of Calotropis procera against alloxan-induced diabetes in rats. Roy S, Sehgal R, Padhy BM and Kumar VL. Journal of Ethnopharmacology 102 (3), 470-473.
- Inhibitory effect of extracts of latex of C. procera against Candida albicans - A preliminary study. Sehgal R, Arya S and Kumar VL. Indian Journal of Pharmacology 2005; 37: 334-335.
- A comparative study on the efficacy of rofecoxib in monoarticular arthritis induced by latex of Calotropis procera and Freund’s complete adjuvant. Kumar VL, Roy S, Sehgal R and Padhy BM. Inflammopharmacology 14 (1), 17-21.
- Evaluation of cytotoxic potential of latex of Calotropis procera and Podophyllotoxin in Allum cepa root model. Sehgal R, Roy S and Kumar VL. Biocell 30 (1), 9-13.
- Calotropis procera latex-induced inflammatory hyperalgesia – effect of bradyzide and morphine. Kumar VL and Sehgal R. Autonomic and Autacoid Pharmacology 27 (3), 143-149.
- An update on new drug discovery & development from molecular approaches. Sehgal R, Nandave M and Ojha S. Pharmatimes 2006; 38 (5):22-25.
- Anti-hyperglycemic effect of latex of Calotropis procera in alloxan induced diabetes. Kumar VL, Roy S, Sehgal R and Padhy BM. Inflammation Research; 54, S193-S194.
- Audits in Clinical Trials. Sehgal R. The Pharma Review 2007; 5(29):61-65.
- Outsourcing Clinical Trials to India - Opportunities and Challenges. Sehgal R. The Pharma Review 2009; 29-30.
- Pharmacovigilance: Role and Importance in Pharmaceutical Industry. Sharma M, Gupta SK, Chatterjee A, Gupta VB and Sehgal R. The Pharma Review 2009; 53-56.
- Sehgal R et. al. Pharmacoepidemiology. Practice of Hospital, Clinical and Community Pharmacy Practice edited by Mohd. Aqil, first edition, Elsevier Health, 2012, Chapter 8.
- Sehgal R et. al. Rational Drug Use and Essential Medicines Concept. Practice of Hospital, Clinical and Community Pharmacy Practice edited by Mohd. Aqil, first edition, Elsevier Health, 2012, Chapter 17.
- Sethi’s HPLC - High Performance Liquid Chromatography: Quantitative Analysis of Pharmaceutical Formulations, Vol. 1-4. CBS Publishers and Distributors Pvt. Ltd., New Delhi, India. 2010.
- Elements of Pharmacovigilance – Be Vigilant, Be Safe. Sehgal R et. al. Kongposh Publications, New Delhi, India. 2010.
Training
- Advanced Clinical Research Training by The Texas Medical Center, Houston TX and SOCRA held on October 27th and November 3rd, 2023.
- Skill Development Programme on Pharmacovigilance of Medical Products organized by NCC-PvPI, Indian Pharmacopoeia Commission from 6-10 Feb 2023.
- Regulatory Pathways to Innovative Clinical Trials conducted by Indian Society of Clinical Research on 26 Feb 2022.
- Submission of Quality Data to Regulators in Collaboration with USFDA held on 25 Feb 2022.
- Regulatory Pathway Workshop on New Drugs and Biopharmaceuticals organized by Innovation Technology Transfer Office (i-TTO), IIT Delhi in association with Clinical Development Services Agency (CDSA), Translational Health Science and Technology Institute (THSTI) on 14 Dec 2021.
- Hands on Training Programme on GCP conducted by CDSA on Jan 28-29, 2020.
- Diversity and Inclusion by Novartis Learning and Development, 2016.
- Manage, Lead and Succeed by Quintiles L&D from 2-4 Dec 2009.
- Barnett Accreditation: Expert GCP EXAM for managers and staff interacting with investigational sites (2012).
- Leading for Performance, by Forum Corporation, Singapore on 8-9 March 2010.
- Coaching and Collaboration, by Forum Corporation, Singapore on 23-24 June 2010.
- Franklin Covey Leadership Workshop - 7 Habits of Highly Successful People conducted in Apr 2011.
- Workshop on 'Dangerous Goods Awareness with Concentration on Preparing, Handling and Transporting Infectious Substances by Air', organized by World Courier (India) Pvt. Ltd. On 7 February 2006.
Key Achievements
Drug Approvals, Supported clinical development of first Multiple Myeloma drug in second-line setting since 2016, achieving FDA accelerated approval, Revenue Growth, Successfully managed $50M+ clinical trial portfolios with 98% on-time delivery, Operational Excellence, Achieved zero critical findings in 15+ regulatory inspections (EMA, DCGI, FDA), Innovation Leadership, Published 10+ peer-reviewed publications in international journals, Team Development, Built and mentored 50+ clinical professionals across multiple regions, Recognition, Received 30+ performance awards for leadership excellence and customer centricity, Process Optimization, Implemented RBQM strategies reducing monitoring costs by 25%, Thought Leadership, Moderate LinkedIn's largest clinical research community (21K+ members)
Personal Information
Profile: A strategic, collaborative leader with two decades of experience in the clinical research and drug development industry. Expert in P&L management, setting operational strategy, and driving high-quality trial execution from early phase to Phase 4 studies across CROs and Sponsors. Proven track record in resource management, executing cost-saving measures, and ensuring ICH/GCP compliance, successfully hosting numerous regulatory inspections (EMA and DCGI) with zero critical findings.
References
- Ms. Suchela Srivatsa, Senior Director & Head Central Operations, Clinical FSP, IQVIA India, suchela.srivatsa@iqvia.com, +91-9886495753
- Ms. Jahanara Nayar Rahuldev, Vice President FSP Biometrics, Parexel, jahanara.rahuldev@parexel.com, +65 97271631
- Ms. Larisa Nagra Singh, Head of Commercial ICON Plc., Singapore, +91-9820712114
- Dr. Saurendra Das, Clinical Research Consultant, saurendas47@gmail.com, +91 9971099950
Timeline
General Manager
Medanta - The Medicity
02.2024 - Current
Director and Head Clinical Operations
PFC Pharma Focus India Pvt. Ltd.
05.2017 - 02.2024
Senior Project Manager
Novartis Healthcare Pvt. Ltd.
06.2016 - 10.2016
Senior Manager
Quintiles Research India Pvt. Ltd. (now IQVIA)
10.2009 - 05.2016
Sr. Clinical Research Associate
ICON Clinical Research
07.2008 - 10.2009
Sr. Clinical Research Associate
GVK BIO
04.2007 - 07.2008
Clinical Research Associate
ICON Clinical Research
10.2006 - 04.2007
Executive - Clinical Research
Panacea Biotec
11.2005 - 09.2006
Master of Science - Pharmacology
All India Institute of Medical Sciences
Bachelor of Pharmacy -
Jamia Hamdard University
Diploma in Pharmacy -
Jamia Hamdard University