Simran Padam
Medical Director Clinical & Research Development Drug Safety Physician Medical Affairs @Premier Research
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WORK HISTORY
Medical Director Clinical & Research Development Drug Safety Physician Medical Affairs @Premier Research
US
Review & provide input on protocol development, amendments, IB, IND/SUSAR Safety reports, clinical study reports, training materials, informed consent, & analysis plan designs •Contribute to the strategic development of early & late-stage clinical trials •Evaluate data on safety, pharmacology, & efficacy from ongoing & completed studies •Conduct literature reviews & prepare summaries to support clinical development programs, study proposals, training session preparation, clinical data interpretation, & report writing •Collaborate with KOLs and/or sponsor representatives to develop inclusion/exclusion criteria & study endpoints •Supporting & Conducting Sponsor/Vendor Audits •Assist the study team in developing criteria for investigatory site selection, networking for potential investigators for study participation, & assisting in the review & final selection •Participate in subject recruitment & retention activities, such as individual calls to KOLs, investigators, & site staff & teleconference & virtual presentation participation •Investigators & monitors’ first point of contact for study-related medical/safety issues & resolution of study protocol & patient eligibility issues •Provide medical review & case assessment of SAEs, including reviewing & editing SAE narratives & safety queries, follow-up on outstanding safety queries, & interacting with sponsors & investigative sites to discuss safety issues as needed •Perform a medical review of eCRFs & coded terms (e.g, AEs, ConMeds, and Medical History) to ensure medical accuracy & consistency •Provide individual & aggregate reviews of clinical & laboratory data & data listings, tables, & figures •Collaborate with Business Development to actively seek new business for Premier Research, including support with marketing presentations & proposal development •Provide subject matter expertise in clinical oncology trials & the biology & treatment of cancer •Provide consulting services to clients
EDUCATION
University of California, Davis
Bachelor of Science - BS, Biology/Biological Sciences, General
Harvard Medical School
Other: HMX Fundamentals/Pro Online Certificate Program - Immuno-Oncology
Harvard Medical School
Other: HMX Fundamentals/Pro Online Certificate Program - Cancer Genomics and Precision Oncology
Medical University of Lublin, Poland
Doctor of Medicine - MD, Medicine
ABOUT SIMRAN PADAM
Hi, I’m Dr. Simran Padam, a Medical Director at Premier Research, a leading clinical research organization that provides services to biotech and pharmaceutical companies. As a passionate and energetic physician-scientist and biopharmaceutical physician with extensive global experience in early and late phase clinical trials in oncology/hemato-oncology, including solid tumors, immuno-oncology, rare disease indications and early phase dose escalation/expansion oncology studies. I have gained this experience while working at comprehensive cancer institutes and CROs and with different Biotech and Pharma companies. I have always shared an affinity for medical research and contributing to clinical trials. I am knowledgeable about current scientific and medical practices, clinical research challenges and opportunities, as well as the evolving global and regional regulatory landscape. I am adept at coordinating with internal and external stakeholders, such as study sites and vendors, and achieving clinical trial objectives. This extends to communicating scientific presentations during investigator and team meetings to keep everyone up to date. I can also leverage my organizational skills to document findings and provide recommendations. I have a proven track record of sharing my passion with up-and-coming talent. I have great experiences coaching and mentoring clinical study teams and assisting recruits in evaluating clinical studies. Furthermore, I have contributed to Breast Oncology research during my tenure at City of Hope and have formulated non-therapeutic trials to assess older adults’ participation in clinical trials. I have also guided clinical safety data management and am effective at utilizing my knowledge of scientific methods and applications based on scientific, medical, and practical rationale. My specialties include immunotherapy (including checkpoint inhibitors, monoclonal antibodies, CAR T-cell therapy), targeted therapy, chemotherapy, cell and gene therapy. I’m passionate about advancing medical science through rigorous research that meets the highest ethical standards. I’m always looking for new opportunities to collaborate with other professionals who share my vision. If you are interested in working with me or learning more about my work, please feel free to connect with me on LinkedIn.
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