Moshe Reiss
Associate Director Clinical Research @Genmab
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WORK HISTORY
Associate Director Clinical Research @Genmab
Princeton, NJ, US
Responsibilities included leading and co-leading FIH clinical trials, including phase 1 dose escalation/expansion studies for CD3-B7H4 and CD40×4-1BB bispecific compounds targeting advanced solid tumor malignancies such as ovarian, endometrial, breast, melanoma, lung, pancreatic, and HNSCC. Significant contributions were made to program strategies by analyzing specific toxicities and trends to align with organizational goals and scientific advancements, while collaborating on the CDP to meet regulatory and patient needs.Extensive involvement in authoring and reviewing key clinical and regulatory documents, including FIH protocols, DSURs, IBs, CTAs, medical monitoring plans, medical data review plans, dose escalation committee charters, dose justification documents, and response letters to regulatory agencies. As chair of medical monitoring meetings, played a pivotal role in overseeing clinical safety and guiding key decisions throughout trials.Cross-functional management across key stakeholders throughout pre-trial and trial activities, including safety, biostatistics, biomarkers, clinical pharmacology, translational medicine, clinical operations, and regulatory affairs, ensuring seamless execution across all phases of development. Contributions to senior management meetings, including the Protocol Review Committee, CDT, CST, and CTT, were key in shaping the strategy for three compounds, ensuring strategic alignment and informed decision-making at the highest levels.Innovated in the creation of eCRFs to ensure data integrity, facilitated cross-functional meetings, and collaborated with KOLs. Member of the onboarding committee and standards governance board to ensure effective integration into clinical trial activities and company protocols, with a strong emphasis on protocol adherence, data accuracy, and clinical excellence. Trained new staff and incoming staff to specific protocols.
EDUCATION
Touro University
BS, Biology
Baruch College
Master of Business Administration (M.B.A.), Health/Health Care Administration/Management
New York University
BSN, Nursing
University of Pennsylvania
MSN, Pediatric Acute Chronic Nurse Practitioner
ABOUT MOSHE REISS
Healthcare Professional with over 13 years of experience in oncology, solid tumor trials, and rare pediatric diseases. Expertise spans leading pre-clinical, FIH, early, and late-stage clinical trials, with a focus on shaping clinical development strategies and overseeing medical monitoring to ensure patient safety and data accuracy. Skilled in competitive intelligence, data and trend analysis, and providing comprehensive safety profiles for specific compounds. Proficient in authoring and reviewing key clinical and regulatory documents, such as protocols, DSURs, IBs, CTAs, dose escalation charters, and medical monitoring plans, with a strong emphasis on ensuring compliance and alignment with regulatory standards.Known for collaborating across various stakeholders including safety, biostatistics, biomarkers, clinical pharmacology, translational medicine, data management, clinical operations, regulatory affairs, quality, medical affairs, legal, business development, and CRO vendors. Adept at working in cross-functional, matrixed environments to drive seamless execution of clinical studies and strategic alignment.Effectively communicates strategic insights to senior leadership, influencing critical decision-making across the drug development process. Experience includes presenting at senior management meetings such as Protocol Review Committees, Scientific Check-ins, and strategy teams like CDT, CST, and CTT. This has been essential in guiding decisions related to clinical strategy, safety, and efficacy for several compounds in oncology pipelines.Possesses a strong educational background, including an MBA in Healthcare Administration and a Master of Science in Nursing (Nurse Practitioner) with a focus on advancing therapeutic solutions through innovative clinical research and patient-centered care. Play a key role in onboarding new clinical team members, ensuring they are effectively integrated into clinical trial activities and aligned with company protocols.With a focus on patient safety, data integrity, and advancing clinical research, brings a comprehensive understanding of the drug development process, from pre-clinical trials to market strategy, while collaborating with cross-functional teams to optimize trial outcomes and guide the future of oncology therapeutics.
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