Jyoti Nehra
Milford,MA
Summary
Clinical research professional with overall 10 years of clinical research experience and 4 years experience in pharmaceutical industry. Driven by science and the desire to develop novel therapies for cancer patients and has a proficiency in the drug development process (especially phase I and II clinical trials), protocol writing & study conduct, data review and reconciliation, the principles of translational medicine, and what it takes to lead teams successfully. Having worked in the department of clinical pharmacology for 6 years, got exposure to the entire range of activities related to drug development including optimizing the dose of drugs through PK/PD modeling.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Medical Director
ASTRAZENECA
Waltham, US
11.2022 - Current
- Provide long-range clinical planning in early clinical trial development, planning and managing of clinical research projects and clinical development programs involving various anticancer agents e.gSmall molecule inhibitors, ADCs, IO in oncology
- Serve as the Project Medical Monitor while working in a cross functional environment
- Contribute to and support Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio
- Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems, and final reports
- Play a role in designing clinical development plans and overall strategy for compounds, therapeutic classes of compounds or indications in light of developments in the area of clinical and pharmaceutical oncology
- Participate in identification, selection and conduct of negotiations with clinical research centers and investigators
- Liaises with colleagues in Clinical Pharmacology to assist in the design and execution of Phase I Clinical trials to establish Proof of Principle and to support Proof of Concept
- Provide clinical expertise to implement dose optimization in phase1/2 trials as part of Project Optimus working group
- Secondment with clinical pharmacology group to provide clinical expertise for Food-drug effect studies, QT study and Drug-drug interaction studies.
Associate Medical Director
ASTRAZENECA
Mississauga, Ontario, CANADA
08.2021 - 11.2022
- Collaborating with cross-functional teams (clinical and translational scientists, biostatisticians, clinical operations, data management, pharmacovigilance and regulatory professionals) for the development of clinical trials (CDID to FTIH as well as phase 1/2)
- Medical monitoring including patient eligibility assessment, safety monitoring in collaboration with pharmacovigilance and close communication with principal investigators (Safety review and dose escalation meetings)
- Designing and executing clinical trials first-in-human Phase I, proof-of-concept Phase I-II in a matrix team environment. Analysis, interpretation, and presentation of clinical study data to senior stakeholders
- Building professional relationships with key opinion leaders in medical oncology
Clinical Research Scientist
PRA HEALTH SCIENCES formerly ReSearch Pharmaceutical Services (RPS)
Blue Bell, Pennysylvania, UNITED STATES
09.2020 - 08.2021
- Accountable for clinical/scientific execution of the protocol
- Led the Medical Monitoring (MM) team in performing MM activities, including the development of the Medical Monitoring Plan (MMP) and review of SAE reports
- Clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites)
- Authored protocol clarification letters
- Responsible for trial design and endpoint development in collaboration with Clinical Director
- Protocols/amendments - collaborated with the medical writer (MW), participated in governance committee review
- Prepared scientific slides, attended and presented protocol information at Investigator Meeting
- Reconciled and reviewed all protocol deviation classifications in SPECTRUM
- Supported Study Manager/Medical Writer activities as needed to achieve CTT deliverables
- Provided clinical specifications to SM to support interactions with external vendors (e.g., IVRS, ePRO)
- Participated in Database lock activities
- Supported publications/presentations as needed
Medical Research Fellow
CANADIAN CANCER TRIALS GROUP, Queen's University
Kingston, Ontario, CANADA
10.2018 - 09.2019
- Patient data review, safety and efficacy assessment
- Oversight of Phase I, II trials conduct under Investigational New drug (IND) program
- Protocol and CRF development
- Participated in transdisciplinary coursework / practicums offered in the Institute-controlled clinical trial, principles of drug discovery and development, basic statistics for epidemiologists
- Summer Internship at AstraZeneca Canada, Mississauga (Ontario)-medical affairs department functions within the pharmaceutical company -focus on lung, hematology, genitourinary, women's cancer and immune-oncology
- Attended formal and informal meetings related to CCTG activities within the central office and with investigators
- Protocol deviations, amendments
- Monitored study progress, ensured accurate study conduct and adherence to the protocol, led data review, evaluation, and analyses with support from Data Management and Stats & Programming team
- Assisted clinical sites with Institutional Review Board (IRB) / Independent Ethics Committee (IEC) submissions
- Participated in design, conduct, monitoring, data interpretation and reporting of individual clinical trials.
Oncotherapeutics Fellow
ADVANCED CENTRE FOR TREATMENT, RESEARCH AND EDUCATION IN CANCER (ACTREC) - TATA
Kharghar, Navi Mumbai, Maharashtra, INDIA
09.2017 - 09.2018
- Led regulatory phase 1 studies, bioequivalence/biosimilar studies, and pharmacokinetic, pharmacogenetic studies in capacity of Sub/Co-Investigator
- Managed the in-house BA/BE team, IEC communication
- Monitored clinical trial progress including, but not limited to, tracking of AEs, SAE and patient eligibility assessment, patient data review, reviewing labs and imaging, ICF review, maintaining cold storage and IP accountability logs, efficacy and safety assessment
- Ensured preparedness for the internal and external auditing
- Established Clinical Operations Department by creating SOPs, templates, and work flows
- Conducted academic sessions on concepts in clinical pharmacology and research methodology for pharmacy and clinical research graduates
- Implemented Therapeutic Drug Monitoring Program in Oncology
- Provided safety content review of clinical protocols, CSRs and ICFs
- Faced a 5 days US-FDA Inspection (Bioequivalence Research Monitoring; BIMO) for a bioequivalence trial in prostate cancer in March 2018
- Led safety strategy for multiple or complex periodic regulatory documents -PSURs, DSURs
- Performed advanced data analyses including population pharmacokinetics, clinical trial simulation and disease modeling
- Led the clinical trials implementation team and had oversight of clinical trial CROs.
Senior Resident
Pt. B.D.Sharma Post Graduate Institute of Medical Sciences
Rohtak, Haryana, INDIA
09.2016 - 09.2017
- Supervised Pharmacovigilance activities of the adverse drug monitoring centre (AMC) under Pharmacovigilance program of India (PvPI)
- Protocol writing and manuscript writing
- Literature review and safety case report writing
- Provided input into ICSRs, PSUR, SAR
- Assessed, reviewed, and evaluated student training activities and progress
- Designed, planned and conducted controlled experiments and/or clinical trials to improve understanding of a drug's activity
- Attended scientific meetings and conferences to present posters, give talks and listen to presentations from other pharmacologists and key opinion leaders
- Ethical principles of animal and human experimentation, ethical clearance procedures, consent forms and information sheets, publication ethics
- Performed a number of service activities e.g
- Therapeutic drug monitoring, pharmacovigilance, pharmacoeconomics and pharmacoepidemiology
- Performed various teaching and training activities for undergraduate and post-graduate medical students and others with a sound understanding of the modern tools of teaching technology
- Performed commonly employed experiments and clinical techniques in Pharmacology and drug research.
Education
DNB - Clinical Pharmacology
National Board of Education
09.2018
MD - Clinical Pharmacology
Pt.B.D. Sharma PGIMS
08.2016
MBBS -
Sikkim Manipal Institute of Medical Sciences
03.2012
Skills
- Clinical Research
- Clinical Pharmacology
- Early Oncology
- Medical monitoring
- Drug development
- Immuno-oncology
- Clinical Strategy
- Patient care
Certification
- Protocol Development, Medical oncology Group of Australia, 09/2020
- Certified Clinical Research Professional (CCRP), Queen's University, 08/2019
- Medical education credential assessment, Medical Council of Canada, 12/2018
- Certified Physician, Delhi Medical Council, 02/2013, 01/2023
Presentations
- Is Sunitinib a good candidate for Therapeutic Drug Monitoring : A prospective study in patients with metastatic renal cell cancer, SAC- ACCP Conference, Mumbai, 2018
- Voriconazole for treatment of invasive fungal infection in paediatric patients: Is there need for a more frequent dosing strategy?, 6th International Congress of Therapeutic Drug Monitoring & Clinical Toxicology 2018 Congress, Brisbane, Australia, 2018
- Strategy for therapeutic drug monitoring (TDM) and its implications on response and tolerability of Sunitinib in patients with metastatic renal cell carcinoma, IPSCON 2017 at SVKM's NMIMS, Mumbai, 2017
Publications
- A Canadian Cancer Trials Group phase IB study of durvalumab (anti-PD-L1) plus tremelimumab (anti-CTLA-4) given concurrently or sequentially in patients with advanced, incurable solid malignancies, J. Nehra, P. A. Bradbury, P. M. Ellis, J. Laskin, Kollmannsberger, D. Hao, R. A. Juergens, G. Goss, P. Wheatley-Price, S. J. Hotte, K. Gelmon, A. V. Tinker, P. Brown-Walker, I. Gauthier, D. Tu, X. Song, Nehra J, Invest New Drugs, 2020, 38, 1442-1447
- DRUG ADVERTISEMENTS IN MEDICAL JOURNALS: AN APPRAISAL, Gupta H, Nehra J, Verma S., WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES, 2018, 7, 12
- Comparison of myo-inositol versus metformin on anthropometric parameters in polycystic ovarian syndrome in women., Nehra J, Kaushal J, Singhal S, Gahlaut V., International Journal of Pharmacy and Pharmaceutical Sciences, 2017, 8, 4, 144-8
- A comparative study of myo-inositol versus metformin on biochemical profile in polycystic ovarian syndrome in women., Nehra J, Kaushal J, Singhal SR, Gahlaut VS, IJPSR, 2017, 8, 4, 1664-70
- Comparison of Effect of Red Clover & Conjugated Estrogen on Menopausal Symptoms and Their Impact on Quality of Life In Postmenopausal Women., Kaushal J, Sangwan P, Nehra J, Chauhan MB, Singhal SR, World Journal of Pharmaceutical Research, 2017, 6, 4, 1095-108
- A comparative study of efficacy and safety of myo- inositol versus metformin in polycystic ovarian syndrome in women., Nehra J, Kaushal J, Singhal S, Gahlaut V, World Journal of Pharmacy & Pharmaceutical Sciences, 2016, 5, 5, 884-96
- Combating MRSA- Novel approaches & therapeutic advances., Nehra J, Kaushal J, European Journal of Biomedical and Pharmaceutical Sciences, 2016, 3, 10, 186-96
- Effect of Myo-inositol versus Metformin on quality of life in polycystic ovarian syndrome in women., Nehra J, Kaushal J, Singhal SR, Gahlaut VS, European Journal of Pharmaceutical & Medical research, 2016, 3, 11, 346-51
Accomplishments
- Chair and Speaker in a joint symposium with IATDMCT YSC in the 36th Annual Meeting for The Japanese Society of Therapeutic Drug Monitoring (JSTDM) (2019, Tokyo)
- Speaker at 1st CHINATDM-IATDMCT Young Scientist Joint Symposium- “International Perspectives on Individualized Precision Medicine”9th International Xiangya Clinical Pharmacy Forum, Changsha, China.
- Sonal Vora Award for Best Woman Presenter
- Travel scholarship for 2018 Australia and Asia Pacific Clinical Oncology Research Development (ACORD) Workshop from National Cancer Institute (NCI), USA
- Dr. U.K. Seth Award as first prize for Oral presentation Venus International Healthcare awards 2018- Young Researcher in Pharmacology Co-authored a chapter " Clinical Pharmacology in Oncology" in TMC textbook of Oncology. Faced a 5 days US-FDA Inspection (Bioequivalence Research Monitoring; BIMO)
- Implemented Therapeutic drug monitoring (TDM) program in hospital setting for anticancer and antimicobial drugs
- Selected for Novartis International BioCamp 2018
Languages
English
Full Professional
Hindi
Native/ Bilingual
References
References available upon request.
Timeline
Medical Director
ASTRAZENECA
11.2022 - Current
Associate Medical Director
ASTRAZENECA
08.2021 - 11.2022
Clinical Research Scientist
PRA HEALTH SCIENCES formerly ReSearch Pharmaceutical Services (RPS)
09.2020 - 08.2021
Medical Research Fellow
CANADIAN CANCER TRIALS GROUP, Queen's University
10.2018 - 09.2019
Oncotherapeutics Fellow
ADVANCED CENTRE FOR TREATMENT, RESEARCH AND EDUCATION IN CANCER (ACTREC) - TATA
09.2017 - 09.2018
Senior Resident
Pt. B.D.Sharma Post Graduate Institute of Medical Sciences
09.2016 - 09.2017
DNB - Clinical Pharmacology
National Board of Education
MD - Clinical Pharmacology
Pt.B.D. Sharma PGIMS
MBBS -
Sikkim Manipal Institute of Medical Sciences
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