JING ZHANG
Germantown,USA
Summary
Medical Director with deep expertise in pharmacovigilance, driving safety strategy and compliance across diverse therapeutic areas. Experienced in signal detection, benefit-risk assessment, and mentoring teams, fostering a culture of scientific excellence and operational efficiency in clinical development.
Overview
35
35
years of professional experience
1
1
Certification
Work History
Medical Director, Global Vaccine Safety | Pharmacovigilance Medical Lead
Novavax
03.2022 - Current
- Led as Pharmacovigilance Medical Lead for multiple global Phase II and III vaccine development programs, providing strategic oversight of safety surveillance, signal detection, benefit-risk assessment, and risk management activities throughout clinical development and post-marketing phases.
- Led medical review of ICSRs, serious adverse events (SAEs), adverse events of special interest (AESIs), aggregate safety data, and post-marketing surveillance findings to support ongoing safety evaluations and regulatory compliance.
- Conducted signal detection and signal evaluation activities through case series review, literature surveillance, data mining analyses, and aggregate safety assessments, identifying and assessing emerging safety risks.
- Chaired Safety Management Team (SMT) meetings and led Safety Monitoring Committee (SMC) reviews, presenting safety findings and benefit-risk assessments to senior leadership and cross-functional stakeholders, facilitating informed decision-making.
- Supported global regulatory submissions, including BLA, EUA, and Marketing Authorization applications, enabling successful approvals of Nuvaxovid across 40+ countries and regions, enhancing global access to the vaccine.
- Authored and reviewed key regulatory safety documents, including DSURs, PSURs/PBRERs, Safety Summary Reports (SSRs), Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), and safety sections of regulatory submissions.
- Collaborated closely with Clinical Development, Regulatory Affairs, Biostatistics, Medical Writing, Clinical Operations, and external partners to integrate safety considerations into development strategy and regulatory planning.
- Developed responses to health authority inquiries and supported inspection readiness activities, ensuring compliance with FDA, EMA, ICH, and global pharmacovigilance requirements.
- Worked closely with the EU Qualified Person Responsible for Pharmacovigilance (QPPV) to support global pharmacovigilance compliance and post-marketing safety obligations.
- Acted as Safety Subject Matter Expert (SME) for multiple development programs, supporting protocol development, risk management activities, safety monitoring plans, and due diligence assessments for business development opportunities.
- Supported VRBPAC preparations and represented the safety function in cross-functional governance discussions, regulatory interactions, and partner safety committees.
- Mentored junior safety team members, fostering skill development and contributing to improvements in safety processes and pharmacovigilance operations.
Associate Medical Director, Pharmacovigilance
Deciphera Pharmaceuticals
Waltham, USA
02.2021 - 03.2022
- Acted as Pharmacovigilance Lead for Rebastinib (DCC-2036) and Vimseltinib (DCC-3014), providing strategic leadership for patient safety, signal management, risk mitigation, and benefit-risk assessment across oncology and rare disease development programs.
- Led safety strategy and medical oversight for Phase I–III clinical studies, including the Phase III MOTION trial in tenosynovial giant cell tumor (TGCT), ensuring proactive safety surveillance, signal detection, and patient risk management throughout development.
- Conducted medical review of SAEs, SUSARs, aggregate safety data, and emerging safety signals, emphasizing causality assessments, case narrative review, MedDRA coding oversight, and signal evaluation activities to ensure patient safety.
- Developed and implemented signal detection and management strategies, leading safety evaluations and presenting benefit-risk assessments and risk mitigation recommendations, influencing decisions at Product Safety Committees, Global Product Teams, and senior leadership.
- Authored and reviewed key clinical and regulatory documents, including protocols, Investigator’s Brochures (IBs), Company Core Data Sheets (CCDS/CCSI), informed consent forms (ICFs), DSURs, PSURs/PBRERs, IND Annual Reports, Clinical Study Reports (CSRs), and safety sections of regulatory submissions.
- Led development and review of BRAT and BRAD documents to support benefit-risk assessments, safety governance decisions, and regulatory interactions.
- Contributed to regulatory filings and health authority interactions by providing strategic medical safety input, regulatory responses, and benefit-risk evaluations for global development programs.
- Functioned as a core member of Global Product Teams and Study Management Teams, partnering with Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Pharmacology, CMC, and CRO partners to integrate safety strategy into product development plans.
- Led and participated in Product Safety Committee meetings, Data Monitoring Committee (DMC) meetings, investigator meetings, and cross-functional safety governance reviews.
- Supported developmental risk management planning and implementation of risk mitigation strategies to ensure alignment between evolving safety profiles and development objectives.
- Recruited, mentored, and managed safety team members, conducting performance evaluations to foster scientific excellence and professional growth, enhancing overall operational effectiveness.
- Collaborated with Safety Operations to strengthen pharmacovigilance processes, SOP compliance, inspection readiness, vendor oversight, and regulatory compliance.
- Supported business development evaluations and due diligence activities by providing medical safety assessments and benefit-risk perspectives for potential development opportunities.
- Conducted scientific literature reviews and aggregate safety analyses to support ongoing signal detection, safety evaluations, and regulatory reporting requirements.
Associate Director, Pharmacovigilance Scientist, Patient Safety Oncology
AstraZeneca
Gaithersburg, USA
10.2017 - 02.2021
- Provided strategic safety leadership and pharmacovigilance oversight for more than 100 Phase II and III immune-oncology studies across gastrointestinal and thoracic malignancies, including HIMALAYA, CASPIAN, Study 22, and MEDI0457 combination programs.
- Led patient safety for multiple oncology development programs, driving safety strategy, signal management, risk mitigation, and benefit-risk assessments throughout global clinical development.
- Led signal detection and evaluation through medical review of SAEs, SUSARs, AESIs, aggregate safety data, literature reports, and post-marketing cases, identifying and assessing emerging safety risks to enhance patient safety.
- Developed and implemented safety monitoring plans and risk management strategies, focusing on immune-mediated adverse events (imAEs) and other clinically significant safety concerns to ensure effective risk mitigation.
- Authored and reviewed key clinical and regulatory documents, including protocols, Investigator’s Brochures (IBs), Company Core Data Sheets (CCDS/CCSI), informed consent forms (ICFs), DSURs, PBRERs, safety management plans, and IDMC reports.
- Supported global regulatory submissions, including sBLA and Marketing Authorization applications, and provided strategic safety input for regulatory interactions and responses to FDA, EMA, and other health authorities.
- Presented safety findings, signal evaluations, and benefit-risk assessments to the Safety Information Review Committee (SIRC), governance committees, and senior leadership to support critical development and regulatory decisions.
- Acted as patient safety representative for more than 500 early-phase Externally Sponsored Research (ESR) studies, providing protocol review, proposal evaluation, and safety guidance across oncology development programs.
- Collaborated with Clinical Development, Regulatory Affairs, Biostatistics, Medical Writing, Clinical Operations, Safety Operations, CROs, and external experts to integrate safety strategy into overall product development plans.
- Led CAPA initiatives, inspection readiness activities, and process improvement programs to strengthen pharmacovigilance compliance, safety reporting quality, and operational effectiveness.
- Facilitated pharmacovigilance agreements and safety governance with co-development partners and external collaborators, ensuring alignment on safety protocols and compliance standards.
- Led AstraZeneca’s Patient Safety Oncology Data Management Project in response to external audits, improving data quality, compliance, and operational performance across oncology safety programs.
- Supported scientific publications, safety communications, and cross-functional discussions to ensure consistent interpretation and communication of evolving safety profiles.
Associate Scientist II / Scientist, Oncology, Infectious Diseases, and RIA
MedImmune / AstraZeneca
Gaithersburg, USA
07.2005 - 10.2017
- Supported oncology, infectious disease, and autoimmune development programs through translational research, preclinical safety evaluations, biomarker development, and early clinical development activities.
- Collaborated with Science Submission Management team and cross-functional development groups on Biologics License Application (BLA) for durvalumab (PD-L1 inhibitor), ensuring comprehensive documentation and regulatory compliance.
- Led translational and preclinical studies supporting oncology programs, including investigation of antibody-drug conjugates (ADCs), DNA damage response pathways, and PARP inhibitor-based therapeutic strategies; co-authored publications focused on BRCA-mutant tumors and precision oncology approaches.
- Generated translational data, pharmacokinetic (PK) predictions, biomarker strategies, and mechanistic insights to inform candidate selection and guide clinical development decisions across multiple therapeutic programs.
- Integrated pharmacology, safety, biomarker, and translational medicine data to advance development of oncology assets from preclinical through early clinical stages, facilitating informed project progression.
- Supported Phase I clinical development of MEDI8897 (anti-RSV monoclonal antibody), including evaluation of safety, tolerability, pharmacokinetics, and translational biomarkers in healthy adult volunteers.
- Contributed to Phase I clinical development of MEDI-545 (anti-IFNAR1 monoclonal antibody; later anifrolumab) in systemic lupus erythematosus (SLE), supporting pharmacology, PK modeling, biomarker analysis, and safety-related scientific assessments.
- Collaborated closely with Clinical Development, Regulatory Affairs, Translational Medicine, Biostatistics, Medical Writing, and Safety teams to support protocol development, study execution, regulatory submissions, and data interpretation.
- Contributed to evaluation and interpretation of preclinical and early clinical safety data to support informed development decisions, risk assessment, and advancement of oncology, infectious disease, and autoimmune programs.
- Supported scientific publications, regulatory documentation, and cross-functional development discussions to communicate emerging translational and safety findings to internal and external stakeholders.
Research Associate, HIV Gene Therapy Researcher
Virxsys
Gaithersburg, USA
08.2004 - 07.2005
- Enhanced preclinical development of HIV gene therapy programs by designing and validating GLP-compliant assays and conducting translational research activities.
- Collaborated with cross-functional teams to design experiments and collect data.
- Analyzed research findings using statistical software and presented results.
- Authored scientific reports and ensured compliance with SOPs, GLP requirements, and quality standards in regulatory documentation.
- Conducted literature reviews to support ongoing research projects.
Research Associate, Preclinical & Translational Research Lead
Human Genome Sciences
Rockville, USA
07.2000 - 04.2004
- Led preclinical and translational studies for TRM-1 (TRAIL-R1 monoclonal antibody) and NSCLC oncology programs, enhancing understanding of therapeutic efficacy.
- Collaborated with clinical development teams to advance Phase II studies through translational research, biomarker evaluation, and data interpretation, facilitating informed decision-making.
- Contributed to preclinical safety assessments and development strategies, enabling oncology candidates' progression into clinical development.
Research Associate
University of Ottawa Heart Institute
Ottawa, Canada
09.1997 - 07.2000
- Designed and executed translational research studies on dose-response relationships and pharmacologic effects of cardiovascular therapies, contributing to advancements in treatment strategies.
- Conducted cardiovascular pharmacology research on antihypertensive therapies and mechanisms of action, leading to multiple peer-reviewed publications.
- Helped develop experimental protocols for clinical studies to ensure effective research design.
- Analyzed data using statistical software for research projects.
- Reviewed literature on various cardiovascular research topics to gather relevant information.
Medical Monitor
MSD
Shanghai, China
09.1995 - 10.1996
- Facilitated global clinical development and safety monitoring for multinational cardiovascular trials, including PRESERVE study, ensuring adherence to regulatory standards.
- Coordinated with investigators and cross-functional teams on clinical trial execution, adverse event reporting, data analysis, and regulatory compliance.
- Reviewed and followed up on adverse event information and clinical study documentation to support pharmacovigilance and clinical safety initiatives.
Physician, Internal Medicine
Zhong Shan Hospital/Shanghai Medical University
Shanghai, China
07.1991 - 09.1995
- Delivered comprehensive patient care, performed diagnostics, and developed treatment plans in internal medicine to enhance patient outcomes.
- Diagnosed patient conditions through thorough examinations and assessments.
- Developed treatment plans based on clinical guidelines and patient needs.
- Collaborated with multidisciplinary teams to enhance patient care strategies.
Education
M.Sc. - Pharmacology
University of Ottawa
01-2000
M.D. -
Shanghai Medical College (Fudan University)
01-1991
Skills
- Pharmacovigilance leadership
- Signal detection
- Benefit-risk assessment
- Risk management
- Regulatory compliance
- Clinical trial oversight
- Quality assurance
- Data analysis
- Clinical metric tracking
- Strategic planning
- Cross-functional collaboration
- Stakeholder engagement
- Effective communication
- Team mentoring
- Problem solving
- Patient care review
Certification
- Pharmacovigilance and Pharmacoepidemiology (AstraZeneca)
- Clinical Research Certification
References
Available upon request
Publications
- Zhong, H., Chen, C., Tammali, R., Breen, S., Zhang, J., et al. (2019). Improved therapeutic window in BRCA mutant tumors with antibody-linked pyrrolobenzodiazepine dimers with and without PARP inhibition. Molecular Cancer Therapeutics, January 2019.
- Christie, R. J., Tiberghien, A. C., Du, Q., Bezabeh, B., Fleming, R., Shannon, A., Mao, S., Breen, S., Zhang, J., Zhong, H., Harper, J., Wu, H., Howard, P. W., Gao, C. (2017). Pyrrolobenzodiazepine Antibody-Drug Conjugates Designed for Stable Thiol Conjugation. Antibodies, 2017.
- Zhong, H., Tammali, R., Chen, C. (Tracy), Fazenbaker, C., Zhang, J., Kennedy, M., Monks, N., Harper, J., Herbst, R., Tice, D. (2017). Synthetic lethal targeting of BRCA deficient tumors with antibody-linked pyrrolobenzodiazepine dimers alone and in combination with PARP inhibitor (Abstract #76). American Association for Cancer Research Annual Meeting, April 1-5, 2017.
- Zhu, Q., McLellan, J. S., Kallewaard, N. L., Ulbrandt, N. D., Palaszynski, S., Zhang, J., Moldt, B., Khan, A., Svabek, C., McAuliffe, J. M., Wrapp, D., Patel, N. K., Cook, K. E., Richter, B. W. M., Ryan, P. C., Yuan, A. Q., Suzich, J. A. (2017). A highly potent extended half-life antibody as a potential RSV vaccine surrogate for all infants. Sci. Transl. Med., 9, 3 May 2017.
- Riggs, J. M., Naiman, B., Zhang, J., Xu, Y., Vainshtein, I., Hay, C., Schifferli, K., Cardarelli, P., Liang, M., Roskos, L., Connor, J., Kolbeck, R., Coyle, A., Fung, M. (2015). Functional and Mechanistic Characterization of Anifrolumab, a Fully Human, Anti-IFNAR1 Monoclonal Antibody for the Treatment of Systemic Lupus Erythematosus (Abstract 10858). American College of Rheumatology Meeting, November 6-11, 2015.
- Zhang, J., Palaszynski, S., Kallewaard-LeLay, N., McAuliffe, J., Ulbrandt, N. (2014). Evaluation of 1G7 and D25 Mabs antiviral activity in Respiratory Syncytial Virus (RSV) A2 and RSV B cotton rat model (Poster 414). Medimmune Science Fair, 2014.
- Zhang, J., Wachter, L., McAuliffe, J., Suzich, J. A., Patera, A. (2011). Development of mouse models of Respiratory Syncytial Virus (RSV) disease using RSV A2 and RSV Line 19 for evaluation of anti-RSV monoclonal antibodies (mAbs). Medimmune Science Day, 2011.
- Kallewaard, N. L., Zhang, J., Palaszynski, S. R., Toll, B., Alfaro, A., Suzich, J. A., Richter, B. W. M. (2009). Cotton rat lung distribution and pharmacokinetics of inhaled motavizumab, a monoclonal antibody against the fusion protein of respiratory syncytial virus (Abstract). Antibody Engineering, December 6-10, 2009.
- Zhang, J., Palaszynski, S. R., Toll, B., Alfaro, A., Suzich, J. A., Richter, B. W. M. (2009). Prophylaxis utilizing nebulized motavizumab, a monoclonal antibody against the fusion protein of Respiratory Syncytial Virus (RSV) (Abstract V-608). IDSA Meeting, October 29-November 1, 2009.
- Richter, B. W. M., Palaszynski, S. R., Zhang, J., Kiener, P. A., Suzich, J. A. (2008). Respiratory Syncytial Virus (RSV) therapy utilizing intranasally delivered motavizumab, a monoclonal antibody against F protein (Abstract V-4145). ICAAC/IDSA Meeting, October 25-28, 2008.
- Delaney, T., Groves, C., Zhang, J., et al. (2007). Role of type 1 interferon in a murine model of scleroderma (Abstract 46). ACR Meeting, November 6-11, 2007.
- Xu, Y., Zhang, J., Schifferli, K., et al. (2007). Antagonizing type-1 interferon receptor ameliorates lupus disease in autoimmune NZB/W F1 mice (Abstract 2134). ACR Meeting, November 6-11, 2007.
- Xu, Y., Zhang, J., Schifferli, K., et al. (2006). IFN-α accelerates lupus disease in lupus-prone NZBW/F1 mice through B cell activation and induction of plasma cell survival (Abstract). ACR Meeting, November 10-15, 2006.
- Xu, Y., Schifferli, K., Zhang, J., Cibotti, R., Kiener, P. A., Gaudie, J., Mao, S-Y., Coyle, A. J. (2006). IFN-α accelerates lupus disease onset through in vivo induction of plasmacytoid dendritic cell (pDC) population in NZB/WF1 mice (Abstract #443). Keystone Meeting, March 21-26, 2006.
- Robin, H., Zhang, J., et al. (2003). TRAIL-R2 mAb (HGS-ETR2), a human agonistic monoclonal antibody to tumor necrosis factor-related apoptosis-inducing ligand receptor 2, affects tumor growth and induces apoptosis in human tumor xenograft models in vivo (Abstract). American Association for Cancer Research 94th Annual Meeting, 2003.
- Alderson, R., Zhang, J., et al. (2002). TRM-1, a fully human TRAIL-R1 agonistic monoclonal antibody, displays in vitro and in vivo anti-tumor activity (Abstract 4240). American Association for Cancer Research 93rd Annual Meeting, 2002.
- Zhang, J., et al. (2001). Peripheral administration of AT1-receptor blockers prevents sympathetic hyperactivity and hypertension by chronic ouabain and hypertonic saline. American Journal of Physiology, 280: H1318-H1323, 2001.
- Zhang, J., et al. (2001). Peripheral administration of AT1-receptor blockers and pressor responses to central angiotensin II and sodium. Canadian Journal of Physiology and Pharmacology, 79:861-867, 2001.
- Zhang, J., et al. (2000). Peripheral administration of AT1-receptor blockers prevents sympathetic hyperactivity and hypertension in ouabain-treated Wistar rats (Abstract). Experimental Biology 2000.
- Zhang, J., et al. (1999). Administration of AT1-receptor blockers inhibits pressor response to central administration of angiotensin II and high sodium in Wistar rats (Abstract). The Canadian Hypertension Society 20th Annual Meeting, 1999.
- Zhang, J., et al. (1996). Coexistence of FOS Protein and proopiomelanocortin mRNA in hypothalamic arcuate nucleus following electroacupuncture. Acupuncture & Electro-therapeutics Res., Vol. 21, pp. 1-5, 1996.
- Wang, M., Zhang, J., et al. (1996). Coexistence of c-fos and perperenkephalin mRNA in periaqueductal gray in rats following formalin test and electroacupuncture. Acta Acad. Med. Shanghai, Vol. 23, No. 4, 1996.
- Qureshi, I., Xi, X., Zhang, J., et al. (1996). The effect of physical fitness on intraocular pressure in Chinese medical students. Chinese Medical Journal, Taipei, Vol. 58, pp. 317-322, 1996.
Therapeutic Experiences
Durvalumab (PD-L1 inhibitor), Tremelimumab (CTLA-4 inhibitor), Spirogen ADC product, Lynparza (PARP inhibitor), Rebastinib (TIE2 inhibitor), Nuvaxovid (COVID-19 vaccine), Nirsevimab (anti-RSV monoclonal antibody), Vimseltinib (CSF1R inhibitor), Anifrolumab (anti-IFNAR monoclonal antibody), Enalapril (ACE inhibitor)
Timeline
Medical Director, Global Vaccine Safety | Pharmacovigilance Medical Lead
Novavax
03.2022 - Current
Associate Medical Director, Pharmacovigilance
Deciphera Pharmaceuticals
02.2021 - 03.2022
Associate Director, Pharmacovigilance Scientist, Patient Safety Oncology
AstraZeneca
10.2017 - 02.2021
Associate Scientist II / Scientist, Oncology, Infectious Diseases, and RIA
MedImmune / AstraZeneca
07.2005 - 10.2017
Research Associate, HIV Gene Therapy Researcher
Virxsys
08.2004 - 07.2005
Research Associate, Preclinical & Translational Research Lead
Human Genome Sciences
07.2000 - 04.2004
Research Associate
University of Ottawa Heart Institute
09.1997 - 07.2000
Medical Monitor
MSD
09.1995 - 10.1996
Physician, Internal Medicine
Zhong Shan Hospital/Shanghai Medical University
07.1991 - 09.1995
M.Sc. - Pharmacology
University of Ottawa
M.D. -
Shanghai Medical College (Fudan University)