Head, Global Oncology Medical Affairs, Clinical Trial Management, Resources, Operations & Governance Daiichi Sankyo, Inc.Head, Global Oncology Medical Affairs, Clinical Trial Management, Resources, Operations & GovernanceBasking Ridge, NJ$271,500–$452,500 / yearFull timeEnsure all key internal stakeholders are aligned on the approach and the conduct of a global studies/programs that will be implemented in multi-regions (US, Europe, ASCA, Japan)- including Regional Medical, Regional Operations, Safety, Regulatory, Quality, Legal/Compliance, Clinical Supply Operations, Global Program Teams, GMAT Leads, GMA leadership. Responsible for primary data evidence generation delivery of GMA programs: Company Initiated studies (CIS), Non-Interventional Studies (NIS) and Expanded Access Programs (EAP) delivery across countries in Oncology Business Unit and other Regions.
Director, Clinical Science Daiichi Sankyo, Inc.Director, Clinical ScienceBasking Ridge, NJ$201,840–$302,760 / yearFull timeProgram related: Integrated Study Team (IST) representative: Creates early development plan and contributes to overall development strategy; Contributes to development of program biomarker strategy; Achieves endorsement for plan by function and team; Interprets and react accordingly to new preclinical/clinical data(e.g. Participates in creation of developmental and regulatory strategies and prepares clinical sections of regulatory documents; acts as the Point of Contact for interactions with regulatory agencies related to clinical matters.
Associate Director, Clinical Science Daiichi Sankyo, Inc.Associate Director, Clinical ScienceBasking Ridge, NJ$162,400–$243,600 / yearFull timeUnder supervision of Clinical Science Asset Lead or Clinical Science Lead within Hematology, drafts development plans, protocol profiles, protocols, informed consent forms, and sections of submission documents. Advanced Technical Expertise: Possess advanced understanding of pre-clinical and clinical research, including protocol writing, data review, study design, and disease area knowledge preferred.
Senior Director, Clinical Development Daiichi Sankyo, Inc.Senior Director, Clinical DevelopmentBasking Ridge, NJ$280,350–$467,250 / yearFull timeMay contribute to addressing questions about medical decisions, clinical data review, protocol deviations, etc., and/or scientific aspects of the study during FDA, MHRA, EMA, and PMDA interactions, such as pre-submissions, end of phase 1/2, and inspections. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
Senior Director, Clinical Development - Hematology Daiichi Sankyo, Inc.Senior Director, Clinical Development - HematologyBasking Ridge, NJ$280,350–$467,250 / yearFull timeMay contribute to addressing questions about medical decisions, clinical data review, protocol deviations, etc., and/or scientific aspects of the study during FDA, MHRA, EMA, and PMDA interactions, such as pre-submissions, end of phase 1/2, and inspections. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
Executive Director, US Medical Research & Strategy, Operations, and Engagement Daiichi Sankyo, Inc.Executive Director, US Medical Research & Strategy, Operations, and EngagementBasking Ridge, NJ$271,500–$452,500 / yearFull timeAdditionally, the Executive Director contributes to excellence in clinical research by developing strategies for lifecycle management, IIS programs and post approval clinical programs in consultation with commercial, development and outside experts, and by building the image of the company as a partner in research projects. Oversee a Medical Affairs oncology team that works alongside Oncology Field Medical Affairs for interactions with Key External Experts in Oncology including advisory boards, Congress activities, and investigator initiated studies, advocacy and sponsorships.
Clinical Research Manager Licensed (RN) - Medicine Clinical Trials Office Mount Sinai Health SystemClinical Research Manager Licensed (RN) - Medicine Clinical Trials OfficeNew York, NY$95,450–$143,175 / yearThe Clinical Trials Office is seeking a highly skilled Clinical Research Nurse manager to lead and support and support a growing portfolio of cellular therapy clinical research, with primary focus on non-malignant CAR-T and cellular therapy studies, while providing transitional collaboration of malignant Bone Marrow Transplant (BMT)/Cellular Therapy programs. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time - discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it.
Clinical Trial Manager/Senior Clinical Trial Manager Precision Medicine Group LLCClinical Trial Manager/Senior Clinical Trial ManagerNY$110,700–$200,900 / yearThis compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com.
Clinical Trials Manager - Center for Interventional Cardiovascular Research and Clinical Trials Mount Sinai Health SystemClinical Trials Manager - Center for Interventional Cardiovascular Research and Clinical TrialsNew York, NY$104,995–$157,492 / yearMount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time - discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology.
NewSenior Clinical Data Coordinator - Clinical Research Hackensack Meridian HealthSenior Clinical Data Coordinator - Clinical ResearchParamus, New JerseyFull timeOrganizes and prepares for all study related sponsor visits up including, but not limited to Pre-Site Initiation Visits, Site Initiation Visits, Routine Monitor Visits, Close-Out Visits, Internal Audits, and Sponsor Audits. Works daily in collaboration with other research team members including but not limited to Principal Investigators, Research Nurse Coordinators, Clinical Research Coordinators, Sponsors, Contract Research Organizations, and employees of Hackensack Meridian Health.
Clinical Research Coordinator, Research Biofluid Management Unit; Monday-Friday, 11AM - 7PM * Oncology clinical research experience preferred * NYU Langone HealthClinical Research Coordinator, Research Biofluid Management Unit; Monday-Friday, 11AM - 7PM * Oncology clinical research experience preferred *New York, NY$70,481.60–$76,450Full timeIntermediate competency in medical terminology, and an advanced competency in Good Clinical Practice (GCP) guidelines, Federal Regulation that govern the conduct of human subjects research as well as Institutional Review Board and institutional policies and procedures related to human subjects research. Record, update, edit, and maintain confidential information relating to research biospecimens onto paperwork and/or web-based forms in a neat, accurate and timely manner and ensure subsequent data collection as required.
NewClinical Trial Manager/Senior Clinical Trial Manager Axsome TherapeuticsClinical Trial Manager/Senior Clinical Trial ManagerNew York City, NYRemote$130,000–$150,000 / yearOur industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer's disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. The Clinical Trial Manager/Senior Clinical Trial Manager provides operational leadership to the study team to ensure project milestones deliver on time, within budget, high quality, and in compliance with the ICH / GCP, regulatory authority's regulations/guidelines, and applicable SOPs.
Clinical Research Coordinator, Research Biofluid Management Unit; Monday-Friday, 11AM - 7PM * Oncology clinical research experience preferred * New York University School of MedicineClinical Research Coordinator, Research Biofluid Management Unit; Monday-Friday, 11AM - 7PM * Oncology clinical research experience preferred *New York, NY$70,481.60–$76,450 / yearIntermediate competency in medical terminology, and an advanced competency in Good Clinical Practice (GCP) guidelines, Federal Regulation that govern the conduct of human subjects research as well as Institutional Review Board and institutional policies and procedures related to human subjects research. Record, update, edit, and maintain confidential information relating to research biospecimens onto paperwork and/or web-based forms in a neat, accurate and timely manner and ensure subsequent data collection as required.
Clinical Research Finance Analyst - Clinical Trial Billing New York University School of MedicineClinical Research Finance Analyst - Clinical Trial BillingNew York, NY$70,481.60–$75,000 / yearThis position liaises with internal and external customers, consults with faculty, the Clinical Research Support Unit, and Departmental Administrative personnel regarding billing, accounts receivable, payment reconciliation and accurate and timely completion study closure process. This position provides post-award financial management of industry sponsored clinical trials, ensuring accurate and timely payments from clinical trial sponsors.
Senior Clinical Lead, Early Clinical & Experimental Therapeutics SanofiSenior Clinical Lead, Early Clinical & Experimental TherapeuticsMorristown, NJ$236,250–$393,750 / yearIn these roles, duties include: Design safe, rapid and informative First-In-Human studies for oncology assets potentially including natural history, experimental model validation, mechanistic and signal seeking, streamlined Proof-of-Mechanism as well as Proof-of-Concept studies providing robust data for early Go/No Go decisions and other pharmacokinetic studies. A key focus of this role is to support the path from the research phase through early clinical development including early and rapid Proof-of-Mechanism/Proof-of-Concept, as well as natural history studies and experimental model validation to contribute to Human Target Validation (HTV) and evaluating the pharmacology of novel therapeutic approaches.
Sr. Engineering Manager Clinical Labs - Clinical Insights Cleerly IncSr. Engineering Manager Clinical Labs - Clinical InsightsNew York, NY$190,000–$219,000 / yearCandidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range. Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.
Clinical Study Manager, Global Clinical Operations - 30014765 Daiichi Sankyo Co LtdClinical Study Manager, Global Clinical Operations - 30014765Basking Ridge, NJ$133,600–$200,400 / yearCRO Oversight: Responsible for the oversight, performance, and management of CRO(s) and 3rd party vendors (sub-contracted by CRO) to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of work within timelines and budget at a task level. Clinical Operations Study Management(Global) has primary accountability for operational execution and delivery of assigned clinical trials, including study level time, cost and quality deliverables.
Clinical Research Associate I - Center for Interventional Cardiovascular Research and Clinical Trials Mount Sinai Health SystemClinical Research Associate I - Center for Interventional Cardiovascular Research and Clinical TrialsNew York, NY$58,661–$81,675 / yearMount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time - discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology.
NewClinical Research Operations Specialist - Clinical Trial Budgets NYU Langone HealthClinical Research Operations Specialist - Clinical Trial BudgetsNew York, NY$70,481.60–$91,000Full timeCollaborates with Research Finance to load an appropriate budget into PeopleSoft and create the chart string Enters finalized sponsor invoicing terms and entered into Clinical Research Management system, including appropriate visit descriptions and payments, invoiced separately procedures, optional procedures, subject stipend and travel terms and other reimbursable items. Serves as the primary liaison between the department/investigator and central office on all matters of study preaward budget processes Releases the study for activation when central office processes are complete and budget and contract are final.