Years of Clinical Research Experience
Suresh Kamireddy
Medical Doctor. Entrepreneur. Clinical Research Professional
Hyderabad
Summary
A self-directed, dynamic, inspirational leader with an unyielding passion for bringing advance treatment options and outcomes for un met medical needs. A medical doctor, entrepreneur, clinical research professional and accomplished global business leader with 16+ years of unique experience across clinical research & technology, in handling CXO, Board Member, advisory and leadership roles with success in designing customer-oriented programs and developing high performing service-oriented teams. Accomplished in working with organizational leaders to establish business goals and devise strategies driving revenue generation and business growth. Proven track record in creating scalable customer service operations infrastructures and leveraging strengths of the teams to nurture relationships with customers.
Overview
16
16
5
5
Diverse experience from start ups to MNCs
Work History
Head, Operations (Clinical & Safety)
4C DRUG SAFETY SERVICES LLP
Hyderabad
10.2016 - Current
- To prepare high level strategic road map aligning with 4C annual objectives, lead clinical operations strategic planning activities and translate strategic decisions into actionable operational plans.
- Accountable for Profit/Loss for over all line function and projects assigned.
- Responsible to support Business Development team in providing inputs for preparing bidding/ proposal documents
- Develop clinical time line and budget forecasts and be accountable for tracking and delivering accordingly.
- Provide direct oversight and management of operations and personnel involved in clinical and safety operations.
- Participate in review, planning and implementation of clinical trials, including evaluating hypothesis, objectives, study design, feasibility, regulatory requirements, and identifying medical and logistical problems that may impede study.
- Provide leadership, strategic oversight, and guidance of Clinical Operations to ensure quality, timeline, resources and budget goals are met.
- Establish performance indicators and apply to ensure successful execution of clinical trials to agreed time line
- Review master service agreements, statements of work, and quality agreements relating to clinical operations
- Ensure effective and constructive integration of clinical operations knowledge and expertise into all applicable Clinical Development activities including integrated development plans, study protocols and other high level clinical/strategic documents (both internal and for clients)
- Represent all aspects of Clinical Operations and provide updates as required to Executive Committee, Project Teams, Board of Directors and other key internal and external stakeholders.
- Plan clinical headcount and hiring needs to meet program workload demands.
- Lead & mentor Clinical operations staff to support successful internal training and its implementation and serve as an advocate for professional development of Clinical Operations staff.
- Oversee, plan and implement Quality Checks for clinical projects and provide leadership and direction to ensure highest standards for compliance with Company SOPs, ICH-GCP guidelines, Regulatory authority regulations and patient safety standards
- Mentor clinical operations staff on Regulatory Inspections process and develop pro-active approach for Inspection readiness
- Assist QA department in development, review and updating clinical and safety SOPs
- Develop and maintain strong relationships with strategic partners, external experts and Investigators to ensure effective execution of internal and external clinical projects.
- Coordinate and liaison with cross functions heads to deliver high quality data deliverables on time and on budget (e.g. development of case report forms, collaboration with statisticians, collaboration with data managers, data overview, clinical study reports, etc.)
- Provide support for regulatory submissions, supporting dossier development and participating in interactions with Drug Control General of India (DCGI) and other regulatory agencies.
FOUNDER & CEO
CLINSYNC CLINICAL RESEARCH PRIVATE LIMITED
Hyderabad
04.2012 - 10.2016
- Founded ClinSync, in 2012 to provide integrated digital driven CRO services.
- Scaled organization from 1 employee team to 300 + employees in 3 years
- Have built and managed various business verticals including Clinical Operations, Bio-Analytical Operations, Data Management, Pharmacovigilance, Medical Writing, Quality Assurance, regulatory services and Bio-statistics
- Have scaled operations to Europe (Brussels), MENA (Jordon), SEA (Thailand) and Mexico
- Have grown 10x ( 3 Cr revenue to 30 Cr) revenue in three years with EBITA from 15% to 22% over three years.
- Have received exit with 2.5x on revenue, with acquisition by Neo Pharma group. in 2016
Associate Director/ GCTL, NIBR
NOVARTIS HEALTH CARE PVT LTD
Hyderabad
06.2008 - 03.2012
- Provide clinical leadership and medical strategic input for all clinical results in the assigned project or section of a clinical program. Clinical deliverables may include clinical sections of individual protocols consistent with the Integrated Development Plans, clinical data review, program standards, clinical components of regulatory documents/registration dossiers, and publications
- Lead development of clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
- Drive execution of the section of the clinical program in partnership with line functions, assigned Global Trial Director, and regional/country medical associates
- Coordinate/conduct ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert
- May be the Program Manager of other associates Support GPCH in ensuring safety of the molecule for the assigned section, may be a core member of the Safety Management Team, and support overall program safety reporting (e.g., Periodic Safety Update Reports, Drug Safety Update Reports and other safety related documents) in collaboration with Patient Safety
- Work with the Clinical Development Head providing medical input into the Development Plan and Clinical Trial Protocol reviews and driving development of disease clinical standards for new disease areas.
- Support the GPCH or CDH in interactions with external partners (authorities, opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal partners (CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, Health Economics & Outcome Research), and decision boards
- Work with NIBR (Novartis Institute of Biomedical Research)/Translational Medical Sciences to drive transition of pre-PoC projects to DDP and with Business Development & Licensing
Clinical & Medical Monitor
Asian Clinical Trials
Hyderabad
06.2007 - 06.2008
- Responsible for clinical and medical monitoring of assigned studies.
- Preparing Monitoring and Safety reports
CLINICAL RESEARCH OFFICER
ASIAN INSTITUTE OF GASTROENTEROLOGY
Hyderabad
06.2006 - 05.2007
- Act as Sub investigator for all clinical trials and medical research conducted at Asian Institute of Gastroenterology
Education
Executive Program in Business Managment -
Indian Institute of Management
Calcutta05-2012
Bachelor of Medicine & Bachelor of Surgery (MBBS) -
Rangaraya Medical College
Kakinada05-2006
Skills
- Business Strategy & Operations
- Clinical Development & Operations
- Financial Modeling
- Business Development
- Strong liaising with Indian regulators
Accomplishments
- Received Best entrepreneur of the year 2015 award from Tie, India and SLP India
- Featured in Forbes India 40 under 40 for the year 2016
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Head, Operations (Clinical & Safety)
4C DRUG SAFETY SERVICES LLP
10.2016 - Current
FOUNDER & CEO
CLINSYNC CLINICAL RESEARCH PRIVATE LIMITED
04.2012 - 10.2016
Associate Director/ GCTL, NIBR
NOVARTIS HEALTH CARE PVT LTD
06.2008 - 03.2012
Clinical & Medical Monitor
Asian Clinical Trials
06.2007 - 06.2008
CLINICAL RESEARCH OFFICER
ASIAN INSTITUTE OF GASTROENTEROLOGY
06.2006 - 05.2007
Executive Program in Business Managment -
Indian Institute of Management
Bachelor of Medicine & Bachelor of Surgery (MBBS) -
Rangaraya Medical College
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