Dr Malathy Munisamy
Leeds,NYK
Summary
I am an experienced and dedicated pharmaceutical physician with a strong foundation in clinical medicine. I have extensive experience in drug development and pharmacovigilance. Over the past 18 years, I have contributed to clinical trials in different areas including neurodegenerative disease, COVID-19 vaccines, and hyperlipidemia as sub-investigator and principal investigator (PI). This has led to the successful completion of clinical trials and helped the delivery of such trials to new medicines used to treat major human ailments (see publications for designated research studies). I have a proven ability to collaborate across multidisciplinary teams and excel at bridging the gap between clinical research and patient care. My expertise includes more than 100 studies in early-phase clinical research including First-in-Man studies and late-phase clinical research. I have had the opportunity to participate in and lead studies in various therapeutic areas such as urology, neurology, dermatology, vaccine therapy, orphan drug therapy, RNAi drug delivery methods, and psychedelics, complemented by a passion for advancing treatment options for patients with Alzheimer's disease and major depression. I am eager to bring my skills to a forward-thinking organization where I can drive impactful advancements in pharmaceutical medicine and contribute to global health outcomes. I am currently undertaking a part-time Masters at the University of Warwick to further develop my skills in clinical trial implementation, design, and execution.
Overview
29
29
years of professional experience
Work History
Research Physician (Locum)
The University of Leeds
10.2024 - Current
- Delivered medical supervision for undergraduates conducting physiology experiments in the school of biological sciences.
- These experiments consisted of 10 groups of students over several days.
- Cross -over design studies involved several sessions.
Clinical Research Physician
MAC Clinical Research
04.2022 - 01.2025
- Optimized patient recruitment methods, resulting in accelerated enrollment rates for multiple studies.
- Managed more than 10 concurrent projects effectively as PI while maintaining strict attention to detail throughout phase II/III studies. Managed 2 late phase studies as chief investigator.
- Mentored 2 junior researchers, fostering a collaborative environment that enhanced overall team performance.
- Enhanced patient safety by meticulously reviewing and analyzing clinical trial protocols.
- Facilitated communication between internal stakeholders and external collaborators, streamlining project coordination efforts.
- Provided medical oversight as PI and Sub-I during clinical trials, ensuring adherence to best practices in patient care and treatment administration.
- Streamlined data management processes for increased efficiency in tracking and reporting study results.
- Co-authored 2 publications, showcasing expertise in various therapeutic areas and bolstering professional credibility.
- Oversaw vendors and managed operations to achieve milestones in gastroenterology studies.
- Identified issues for escalation, participated in problem solving and implemented risk mitigation strategies during physician meetings and study meetings.
- Generated and maintained reports, listings and trackers.
- Involved in evaluating investigational products' safety and efficacy by conducting comprehensive analyses of trial data.
- Monitored and recorded patient progress, prompting timely and appropriate interventions.
- Improved regulatory compliance through rigorous audit preparation and documentation practices.
- Educated patients and families on health conditions to raise awareness.
- Collected, recorded and maintained patient medical history, reports and examination results.
- Monitored patients' conditions and progress to reevaluate treatment, giving feedback to sponsors in Alzheimer's study.
- Provided and managed direct patient care by conducting physical examinations, evaluations and assessments to determine diagnosis.
- Participated in continuing education and professional development to enhance expertise and skills.
Clinical Research Fellow
Patient Recruitment Centre, Bradford Royal Infirmary
10.2020 - 03.2022
- Supervised data collection by core research staff for a large COVID-19 trial involving approximately 900 patients.
- Assisted with analysis of research data in collaboration with research department, during national level meetings involving the Oxford research group and collaborating hospitals all over UK.
- Contributed to scholarly manuscripts and final study reports to communicate results of research to broader scientific community.
- Contributed to groundbreaking medical advancements by conducting cutting-edge research evaluating COVID-19 clinical trial patients in a completely sterile environment using PPE equipment.
- Maintained detailed documentation of all consent forms, study procedures, ensuring transparency and reproducibility of results across multiple investigations. Managed adverse events and serious adverse events and updated the lead investigator in real time.
- Provided mentorship and guidance to junior staff, promoting a culture of continuous learning and development.
- Conducted regular audits of study data, identifying discrepancies and implementing corrective actions as needed to maintain data integrity.
- Efficiently managed project timelines, consistently meeting or exceeding deadlines for key deliverables such as data submission or progress reports.
- Actively pursued continuing education opportunities in order to stay current on emerging trends within the field of clinical research.
- Collaborated with industry partners to develop novel therapeutic approaches based on study results, ultimately benefiting countless patients worldwide.
- Ensured strict adherence to ethical guidelines throughout all stages of clinical trials, maintaining institutional integrity while safeguarding participant safety and wellbeing on 10 respiratory studies for several sponsors.
- Established strong working relationships with fellow researchers, enabled me to take part in data gathering for genetic research in a special study involving the Asian population in Bradford.
- Published articles in high-impact journals, increasing visibility of the institution's work and contributing to its reputation as a leader in clinical research.
Clinical Research Fellow
Dementia Research Centre, University College, London
01.2016 - 10.2017
- Supervised data collection by core research staff in 3 phase I Alzheimer's studies and 2 phase II Alzheimer's studies.
- Attended and gave seminars under direction of head of novel therapeutics.
- Assisted with analysis of research data in collaboration with research department, collaborating with colleagues from the neuropsychology team.
- Participated in developing and improving the patient data base and recruitment by a 100% within a year's time. Optimized patient recruitment methods, resulting in accelerated enrollment rates for multiple studies.
- Trained to recruit nursing support for studies by collaborating with the research framework in the NHS.
- Clinically trained to recruit patients from the dementia outpatient clinic for Alzheimer's clinical trials at the National Neurology Hospital. Developed robust methodologies for enhancing the overall quality of research findings by collaborating with monitors from sponsor companies.
- Maintained detailed documentation of all study procedures, ensuring transparency and reproducibility of results across multiple investigations.
- Provided mentorship and guidance to junior staff, promoting a culture of continuous learning and development.
- Efficiently managed project timelines, consistently meeting or exceeding deadlines for key deliverables such as data submission or progress reports. Received mention for recruiting the first patient in UK and second in EU for a phase 1 dementia clinical trials.
- Participated in interdisciplinary meetings to share research findings and discuss potential implications for clinical practice or policy change.
- Assisted with the recruitment and training of junior research fellows, fostering a supportive learning environment conducive to professional growth.
- Actively pursued continuing education opportunities in order to stay current on emerging trends within the field of clinical research.
- Collaborated with industry partners to develop novel therapeutic approaches based on study results, ultimately benefiting countless patients worldwide.
Clinical Research Physician
Covance Clinical Research Unit
01.2009 - 01.2013
- Managed more than a 100 concurrent projects effectively while maintaining strict attention to detail throughout all phases.
- Mentored junior researchers, fostering a collaborative environment that enhanced overall team performance.
- Enhanced patient safety by meticulously reviewing and analyzing clinical trial protocols and presenting at interim safety reports to sponsors at regular intervals. Facilitated communication between internal stakeholders and external collaborators, streamlining project coordination efforts.
- Received training in specific patient assessments in dermatology, neurology and radio-labelled studies.
- Ensured alignment with global standards by participating in international collaborations related to clinical research best practices.
- Provided medical oversight during clinical trials, ensuring adherence to best practices in patient care and treatment administration. Managed serious adverse events and reported them immediately.
- Developed strong relationships with external partners, ensuring timely sharing of information and resources for successful study completion, thereby ensuring repeat business.
- Co-Authored publications, showcasing expertise in various therapeutic areas and bolstering professional credibility.
- Participated in new study designs which were developing at that time.
- Identified issues for escalation, participated in problem solving and implemented risk mitigation strategies in cardiac clinical trials and psychiatric drug clinical trials.
Medical Advisor Pharmacovigilance
Eisai Ltd.
01.2007 - 01.2009
- Developed innovative strategies for maximizing patient access to life-changing therapies, improving overall health outcomes.
- Held a safety database for an oncology portfolio of 5 concurrent phase I projects and 2 phase IV studies. One of which required an analysis of the occurrence of suicidal tendencies for a PSUR report.
- Evaluated SAE and AE reviews.
- Involved in PSUR submissions
- Participated in Safety and risk management activities
- Participated in Signal detection activities
- Involved in Drug Safety case reviews conducted.
- Streamlined drug development processes for increased efficiency and reduced time to market.
SHO General Medicine and A&E
NHS Professionals Locum Agency and King George Hospital BHR NHS Trust Hospitals
01.2004 - 01.2007
PRHO General Medicine
Southmead Hospital North Bristol NHS Trust Hospitals
01.2003 - 01.2004
Clinical Attachment
King George Hospital BHR NHS Trust Hospitals
01.2001 - 01.2003
Clinical Research Coordinator
Changi General Hospital
01.1999 - 01.2001
PRHO
M.S. Ramaiah Medical College
01.1996 - 01.1997
Education
MSc - Clinical Research
University of Warwick
09-2026
Diploma - Pharmaceutical Medicine
Cardiff University
Cardiff, CF10 3AT01.2010
MBBS -
Bangalore University
Bangalore, Karnataka01.1996
Skills
- Clinical study consent procedures
- Physical examination
- Laboratory interpretation
- Clinical diagnosis
- Pharmaceuticals prescription
- Follow-up care
- Resource optimization
- Medical coding
- Patient assessments
- Medical records management
- Prescription writing
- Quality improvement
- Staff education and training
- Patient safety
- Teaching and mentoring
Affiliations
- General Medical Council
- Medical Defence Union
- Faculty of Pharmaceutical Medicine
Clinical Research Experience
Neurology, Dementia, Diabetic neuropathy, Vaccine therapy for COVID-19, RSV, Orphan drugs, Transthyretin amyloidosis, RNAi Drug Delivery, Novel PDE4 therapeutics, Psychedelics, Ulcerative colitis, Alzheimer's Disease, Macfarlane et al., 2025, Ulcerative Colitis, Sands et al., 2024, COVID-19 Vaccine Clinical Trials, Heath et al. (2021), Toback et al. (2022), COVID-19 Host Genetics Initiative (2023), Neurodegenerative Disease Clinical Trials, Munisamy et al., 2016; 2017, RNAi Therapy for Transthyretin Amyloidosis, Coelho et al., 2013, Hyperlipidemia, Fitzgerald et al., 2014, Sildenafil in Erectile Dysfunction, Lim et al., 2002; Ng et al., 2002
Personal Information
Gender: Female
Publications
- Blarcamesine for the treatment of Early Alzheimer's Disease: Results from the ANAVEX2-73-AD-004 Phase IIB/III trial., Macfarlane S, Grimmer T, Teo K, O'Brien TJ, Woodward M, Grunfeld J, Mander A, Brodtmann A, Brew BJ, Morris P, Short C, Kurrle S, Lai R, Bharadwaj S, Drysdale, Sturm J, Lewis SJG, Barton D, Kalafatis C, Sharif S, Perry R, Mannering N, MacSweeney JE, Pearson S, Evans C, Krishna V, Thompson A, Munisamy M, Bhatt N, Asher A, Connell S, Lynch J, Rutgers SM, Dautzenberg PL, Prins N, Oschmann P, Frölich L, Tacik P, Peters O, Wiltfang J, Henri-Bhargava A, Smith E, Pasternak S, Frank A, Chertkow H, Ingram J, Hsiung GR, Brittain R, Tartaglia C, Cohen S, Villa LM, Gordon E, Jubault T, Guizard N, Tucker A, Kaufmann WE, Jin K, Chezem WR, Missling CU, Sabbagh MN., J Prev Alzheimers Dis., 01/01/25, 12, 1, 100016, 10.1016/j.tjpad.2024.100016, 39800452
- Phase 2 Trial of Anti-TL1A Monoclonal Antibody Tulisokibart for Ulcerative Colitis., Sands BE, Feagan BG, Peyrin-Biroulet L, Danese S, Rubin DT, Laurent O, Luo A, Nguyen DD, Lu J, Yen M, Leszczyszyn J, Kempiński R, McGovern DPB, Ma C, Ritter TE, Targan S; ARTEMIS-UC Study Group., N Engl J Med., 09/26/24, 391, 12, 1119-1129, 10.1056/NEJMoa2314076, 39321363
- A second update on mapping the human genetic architecture of COVID-19., COVID-19 Host Genetics Initiative., Nature., 09/01/23, 621, 7977, E7-E26, 10.1038/s41586-023-06355-3, 37674002, PMC10482689
- Safety, immunogenicity, and efficacy of a COVID-19 vaccine (NVX-CoV2373) co-administered with seasonal influenza vaccines: an exploratory substudy of a randomised, observer-blinded, placebo-controlled, phase 3 trial., Toback S, Galiza E, Cosgrove C, Galloway J, Goodman AL, Swift PA, Rajaram S, Graves-Jones A, Edelman J, Burns F, Minassian AM, Cho I, Kumar L, Plested JS, Rivers EJ, Robertson A, Dubovsky F, Glenn G, Heath PT; 2019nCoV-302 Study Group., Lancet Respir Med., 02/01/22, 10, 2, 167-179, 10.1016/S2213-2600(21)00409-4, 34800364, PMC8598212
- Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine., Heath PT, Galiza EP, Baxter DN, Boffito M, Browne D, Burns F, Chadwick DR, Clark R, Cosgrove C, Galloway J, Goodman AL, Heer A, Higham A, Iyengar S, Jamal A, Jeanes C, Kalra PA, Kyriakidou C, McAuley DF, Meyrick A, Minassian AM, Minton J, Moore P, Munsoor I, Nicholls H, Osanlou O, Packham J, Pretswell CH, San Francisco Ramos A, Saralaya D, Sheridan RP, Smith R, Soiza RL, Swift PA, Thomson EC, Turner J, Viljoen ME, Albert G, Cho I, Dubovsky F, Glenn G, Rivers J, Robertson A, Smith K, Toback S; 2019nCoV-302 Study Group., N Engl J Med., 09/23/21, 385, 13, 1172-1183, 10.1056/NEJMoa2107659, 34192426, PMC8262625
- Effect of an RNA interference drug on the synthesis of proprotein convertase subtilisin/kexin type 9 (PCSK9) and the concentration of serum LDL cholesterol in healthy volunteers: a randomised, single-blind, placebo-controlled, phase 1 trial., Fitzgerald K, Frank-Kamenetsky M, Shulga-Morskaya S, Liebow A, Bettencourt BR, Sutherland JE, Hutabarat RM, Clausen VA, Karsten V, Cehelsky J, Nochur SV, Kotelianski V, Horton J, Mant T, Chiesa J, Ritter J, Munisamy M, Vaishnaw AK, Gollob JA, Simon A., Lancet., 01/04/14, 383, 9911, 60-68, 10.1016/S0140-6736(13)61914-5, 24094767, PMC4387547
- Safety and efficacy of RNAi therapy for transthyretin amyloidosis., Coelho T, Adams D, Silva A, Lozeron P, Hawkins PN, Mant T, Perez J, Chiesa J, Warrington S, Tranter E, Munisamy M, Falzone R, Harrop J, Cehelsky J, Bettencourt BR, Geissler M, Butler JS, Sehgal A, Meyers RE, Chen Q, Borland T, Hutabarat RM, Clausen VA, Alvarez R, Fitzgerald K, Gamba-Vitalo C, Nochur SV, Vaishnaw AK, Sah DW, Gollob JA, Suhr OB., N Engl J Med., 08/29/13, 369, 9, 819-29, 10.1056/NEJMoa1208760, 23984729
- The use of sildenafil in patients with erectile dysfunction in relation to diabetes mellitusa study of 1,511 patients., Ng KK, Lim HC, Ng FC, Li MK, Consigliere D, Chia SJ, Moorthy P, Munisamy M., Singapore Med J., 08/01/02, 43, 8, 387-90, 12507022
- Clinical efficacy and safety of sildenafil citrate (Viagra) in a multi-racial population in Singapore: A retrospective study of 1520 patients., Lim PH, Li MK, Ng FC, Chia SJ, Consigliere D, Gooren L, Ng KK, Munisamy M, Perianan M., Int J Urol., 06/01/02, 9, 6, 308-15, 10.1046/j.1442-2042.2002.00425.x, 12110094
Clinical Training Expertise
- Standard Operating Procedures Written
- Seizure Management
- Lumbar Puncture
- Management of Severe Dystonia
- Serious Adverse Event Reporting
- Trainer for clinical & technical staff
- Immediate clinical assessment & management of severe dystonia
- Resuscitation during a seizure and call for help
- Subcutaneous injection training
- Documentation of rashes through photographic evidence
- Basic and Intermediate Life Support Training
- Recognizing, calling for help, assisting and recording Severe Adverse Events
- Lumbar Puncture Clinic – Training was delivered using atraumatic needles for the lumbar puncture procedure.
- Undergraduate Teaching – UCL, London.
- Undergraduate Teaching at the University of Leeds.
- Undergraduate Teaching at Bradford Royal Infirmary.
- Assessor role for Nurse Prescribing.
- Trainee mentor for Sub-Investigators in clinical studies.
- Protocol training for junior staff
- Study-related procedure training for junior staff
Timeline
Research Physician (Locum)
The University of Leeds
10.2024 - Current
Clinical Research Physician
MAC Clinical Research
04.2022 - 01.2025
Clinical Research Fellow
Patient Recruitment Centre, Bradford Royal Infirmary
10.2020 - 03.2022
Clinical Research Fellow
Dementia Research Centre, University College, London
01.2016 - 10.2017
Clinical Research Physician
Covance Clinical Research Unit
01.2009 - 01.2013
Medical Advisor Pharmacovigilance
Eisai Ltd.
01.2007 - 01.2009
SHO General Medicine and A&E
NHS Professionals Locum Agency and King George Hospital BHR NHS Trust Hospitals
01.2004 - 01.2007
PRHO General Medicine
Southmead Hospital North Bristol NHS Trust Hospitals
01.2003 - 01.2004
Clinical Attachment
King George Hospital BHR NHS Trust Hospitals
01.2001 - 01.2003
Clinical Research Coordinator
Changi General Hospital
01.1999 - 01.2001
PRHO
M.S. Ramaiah Medical College
01.1996 - 01.1997
Diploma - Pharmaceutical Medicine
Cardiff University
MSc - Clinical Research
University of Warwick
MBBS -
Bangalore University