Rengith Mathew
Summary
A dynamic and result-driven Associate Director/Clinical Scientist with extensive experience in scientific planning, strategy, and execution within oncology. Skilled in collaboration with global, cross-functional teams, ensuring effective study protocol knowledge and contributing to clinical research success. Proven track record in talent development through proactive coaching and mentoring. Expertise in clinical execution, FDA regulations, regulatory collaboration, clinical data review, and study startup design.
Overview
24
24
years of professional experience
1
1
Certification
Work History
ASSOCIATE DIRECTOR, MEDICAL ADVISOR ONCOLOGY
Novartis Pharmaceuticals
11.2023 - Current
- Serve as a subject matter expert in oncology
- Collaborate with medical writers on clinical and regulatory documents
- Partner with Study Managers on study deliverables and startup design
- Collaborate with medical monitoring teams on data review and protocol deviations
- Work with lead clinical scientists on trial execution and protocol development
- Ensure Compliance with Medical and Ethical Standards
- Review promotional content for regulatory compliance
- Verify that medical claims are scientifically valid, consistent with product labeling and adhere to health authority requirements
- Stay informed on regulatory changes affecting products or trials
- Collaborate with Legal, Regulatory, Commercial, and Medical Teams
- Monitor Post-Market Surveillance Compliance
- Educate and train staff on medical and ethical standards
- Stay updated on evolving healthcare regulations
- Conduct risk assessments of new materials
- Led a team that reduced document review times by 20%, increasing efficiency in product approval processes
- Contributed to the approval of over 5 oncology drugs by ensuring clinical trial data met regulatory standards, aiding in early market entry
- Identified and corrected data inconsistencies in clinical trial reports, preventing delays in regulatory submission and ensuring accuracy in product labeling
- Reviewed clinical trial protocols and data from Phase I-III studies, ensuring safety, efficacy, and compliance with regulatory standards, contributing to the approval of more than 5 drugs
Associate Director, MEDICAL INFORMATION ONCOLOGY
Novartis Pharmaceuticals
04.2020 - 11.2023
- Led a team of 10 medical information professionals
- Developed and implemented a comprehensive medical information strategy
- Oversaw the creation of scientifically accurate, regulatory-compliant content
- Managed the medical inquiry system efficiently
- Led the development of medical training programs for internal stakeholders, including sales and marketing teams
- Collaborated closely with cross-functional teams across medical affairs, regulatory, clinical development, and commercial departments
- Developed performance metrics for the medical information team, resulting in continuous improvements and a 25% increase in productivity
- Managed day-to-day operations of the medical information department seamlessly
- Spearheaded the creation of a centralized medical information database
- Collaborated with the medical affairs team to design and execute medical communication strategies, including scientific symposia, advisory boards, and educational webinars
- Trained and mentored junior medical information professionals, fostering a collaborative and results-oriented environment that promoted growth and development
- Responded to over 500 medical inquiries annually, providing healthcare professionals with accurate and up-to-date information on pharmaceutical products and therapeutic areas
- Reviewed scientific literature and clinical trial data, ensuring all responses were based on the latest and most reliable evidence
- Collaborated with cross-functional teams to develop medical education content
- Responded to over 500 medical inquiries per year, offering healthcare professionals accurate and current information on pharmaceutical products and therapeutic areas
- Leadership and Team Development
- Improved Inquiry Management System
- Digital and Content Strategy
SENIOR MANAGER, MEDICAL INFORMATION | CONTRACTOR
Novartis Pharmaceutical Health Sciences
07.2019 - 04.2020
- Supported the team in addressing medical inquiries through various channels, including the sales force, phone calls, and real-time medical information (RTMI)
- Contributed to the creation of Medical Reference Documents (MRDs) by actively participating in the peer review process to ensure accuracy and quality
- Conducted comprehensive literature reviews for product New Drug Application (NDA) annual submissions in compliance with regulatory standards
- Provided precise and balanced medical/scientific responses to unsolicited inquiries from healthcare professionals (HCPs)
- Analyzed promotional materials for legacy approved products to ensure compliance with regulatory standards
- Conducted literature searches using PubMed, Ovid, and Embase
- Collaborated with cross-functional teams, including Marketing, Sales, and Medical Affairs, to provide support and insights for the development of promotional materials and campaigns
- Stayed informed about the latest product information, therapeutic areas, and industry trends to effectively address inquiries and provide valuable information to HCPs
MANAGER, MEDICAL INFORMATION | CONTRACTOR
PRA Health Sciences
01.2017 - 07.2019
- Handled all medical inquiries promptly, accurately, and compliantly
- Developed and maintained detailed databases of scientific literature and product information for efficient HCP responses
- Created medical communication materials like scientific briefing documents and internal educational content for marketing and sales support
- Facilitated development of medical education materials and training to enhance knowledge on product use and clinical trial data
Medical Office Manager
Centra Clinic
01.2008 - 01.2010
Senior Pharmacy Technician
Walgreens Pharmacy
01.2001 - 01.2008
Education
Doctor of Medicine (M.D.) -
Avalon University School of Medicine (AUSOM)
01.2015
Bachelor of Science - Medical Science
University of St. Eustatius School of Medicine
01.2010
Bachelor of Science - Biology, Minor in Chemistry
Texas Southern University
Houston, TX01.2007
Skills
- Data Review and Trend Identification
- Medical Research and Writing
- Managing Multiple Competing Priorities
- Time Management Skills for Deliverables
- Collaborate with Key Stakeholders
- Ability to survey and interpret scientific literature
- Problem Solving and Conflict Resolution
- Excellent Communication and Presentation Skills
- Medical Monitoring
- Talent Development
Accomplishments
1. Led a team that reduced document review times by 20%, increasing efficiency in product approval processes.
2. Led approval of over 5 oncology drugs by ensuring clinical trial data met regulatory standards, aiding in early market entry.
3. Identified and corrected data inconsistencies in clinical trial reports, preventing delays in regulatory submission and ensuring accuracy in product labeling.
4. Responded to over 500 medical inquiries per year, offering healthcare professionals accurate and current information on pharmaceutical products and therapeutic areas.
5. Leadership and Team Development.
6. Digital and Content Strategy
Certification
- Medical Monitoring for Drugs and Biologics, 01/2024
- Protocol Development and Execution Essentials of Pharmacovigilance, 01/2024
- GCP for Clinical Trials with Investigational Drugs and Medical Devices (US FDA Focus), 01/2024
- Collaborative Institutional Training Initiative Program, 01/2024
- Pharmaceutical Industry Pharmacovigilance and Drug Safety, 01/2024
- Regulatory Updates for Clinical Research Professionals, 01/2024
- Advanced Post-Graduate Diploma in Pharmaceutical Medicine, James Lind University, Geneva, Switzerland, 01/2018
- Clinical Research Associate (CRA)/ Clinical Research Coordinator (CRC) Certification, Barnett University, 01/2017
Summary Of Experience
A dynamic and result-driven Associate Director/Clinical Scientist with extensive experience in scientific planning, strategy, and execution within oncology. Skilled in collaboration with global, cross-functional teams, ensuring effective study protocol knowledge and contributing to clinical research success. Proven track record in talent development through proactive coaching and mentoring. Expertise in clinical execution, FDA regulations, regulatory collaboration, clinical data review, and study startup design.
Technical Acumen
- MedDRA
- GeoDart
- Aprimo
- FUSE
- MIDOCs
- Salesforce.com
- Midus Windows
- Microsoft Office Applications (Word, Excel, PowerPoint, and Publisher)
Awards
- Honors in Core Clerkships: Internal Medicine, Family Practice, Surgery, OB/GYN, Pediatrics, and Psychiatry
- Honors in Elective Clerkship: Emergency Medicine, Cardiology, Ophthalmology, Dermatology, and Neurology
- Recognition Award: St. Rose Hospital in Las Vegas for Patient Care
Area Of Expertise
- Data Review and Trend Identification
- MLR Reviewer for Promotional and Non Promotional Materials
- Therapeutic Area Knowledge
- Medical Writing
- Protocol and CSR Development and Review
- Collaboration Skills with Marketing, Scientific Communication, Publication, HEOR, Regulatory, Legal, Market Access, Payor
- Medical Information
- Data Analysis
- Real World Evidence
- Medical Strategic Planning
Languages
Malayalam
Full Professional
English
Full Professional
Spanish
Elementary
Timeline
ASSOCIATE DIRECTOR, MEDICAL ADVISOR ONCOLOGY
Novartis Pharmaceuticals
11.2023 - Current
Associate Director, MEDICAL INFORMATION ONCOLOGY
Novartis Pharmaceuticals
04.2020 - 11.2023
SENIOR MANAGER, MEDICAL INFORMATION | CONTRACTOR
Novartis Pharmaceutical Health Sciences
07.2019 - 04.2020
MANAGER, MEDICAL INFORMATION | CONTRACTOR
PRA Health Sciences
01.2017 - 07.2019
Medical Office Manager
Centra Clinic
01.2008 - 01.2010
Senior Pharmacy Technician
Walgreens Pharmacy
01.2001 - 01.2008
Bachelor of Science - Medical Science
University of St. Eustatius School of Medicine
Bachelor of Science - Biology, Minor in Chemistry
Texas Southern University
Doctor of Medicine (M.D.) -
Avalon University School of Medicine (AUSOM)
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