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, drafts development plans, protocol profiles, protocols, informed consent forms, and sections of submission documents. Provides strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan and to Clinical Operations on SDV plan.
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.
NewClinical Assessment RN (UAS) - Broome/Allegany VNS HealthClinical Assessment RN (UAS) - Broome/AlleganyNew York, NY$85,000–$106,300 / yearMinimum two years of clinical assessment, homecare or hospital experience preferredExcellent organizational and time management skills, interpersonal skills, verbal and written communication skills requiredDemonstrates strong relationship management skills, including a high degree of interpersonal communication l and non-aggressive assertiveness requiredDemonstrates successful conflict management skills and achieving “win-win” solutions requiredWorking knowledge of Microsoft Suite Products e.g. Current license to practice as a Registered Professional Nurse in New York State requiredCertified Case Manager preferredValid driver's license or NYS Non-Driver photo ID card required as determined by operational/regional needs required.
Executive Director, Head of Clinical Supply Planning and Operations SCM Daiichi Sankyo, Inc.Executive Director, Head of Clinical Supply Planning and Operations SCMBasking Ridge, NJ$255,000–$425,000 / yearFull timeAdditionally, as the regional head of DSI (US) CSO, this position will 1) Oversee all the Clinical Supply Operation-related functions in DSI, 2) Ensure alignment between DSI-CSO and TECH Unit sub-functions (Project Lead (CMC), Regulatory Affairs CMC, Process Technology Research, Formulation Technology Research, and Analytical & Quality Evaluation Research), 3) Make the best effort to increase the total performance of the TECH Unit. Responsible for leading all Clinical Supply Operation (CSO)-related activities for oncology and specialty medicine drug candidates from early development to launch and life cycle management of products globally to achieve the business success of Daiichi Sankyo Group and managing the Global-CSO function from Daiichi Sankyo Inc. (DSI).
NewClinical Manager-Care Management-Hybrid VNS HealthClinical Manager-Care Management-HybridNew York, NY$93,400–$116,800 / yearMinimum two years clinical experience requiredMinimum of two years managerial experience in a LHCSA or CHAA preferredProficiency in Microsoft Office applications requiredExcellent problem-solving and organizational, interpersonal, and verbal and written communication skills required. We’re one of the largest nonprofit home- and community-based health care organizations in the country, and today, more than 11,500 team members work together to make a difference in the lives of more than 99,000 patients and members on any given day.
NewClinical Assessment RN (UAS) - Chenango / Putnam VNS HealthClinical Assessment RN (UAS) - Chenango / PutnamNew York, NY$85,000–$106,300 / yearMinimum two years of clinical assessment, homecare or hospital experience preferredExcellent organizational and time management skills, interpersonal skills, verbal and written communication skills requiredDemonstrates strong relationship management skills, including a high degree of interpersonal communication l and non-aggressive assertiveness requiredDemonstrates successful conflict management skills and achieving “win-win” solutions requiredWorking knowledge of Microsoft Suite Products e.g. Current license to practice as a Registered Professional Nurse in New York State requiredCertified Case Manager preferredValid driver's license or NYS Non-Driver photo ID card required as determined by operational/regional needs required.
NewClinical Manager - Pediatric Service Line Night Flex NewYork-PresbyterianClinical Manager - Pediatric Service Line Night FlexNew York, NY$145,000–$168,000 / yearAs the Pediatric Service Line Clinical Manager, you will lead a Magnet designated nursing team and collaborate with the transformational leaders of the entire pediatric team, working closely with the three units’ Patient Care Directors and fellow Clinical Managers. Description: The Epicenter of Pediatric Nursing in a World Class Organization Clinical Manager - Pediatric Service Line Night Flex At NewYork-Presbyterian, amazing things are truly happening!
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.
NewMedical Director (Oncology) GenmabMedical Director (Oncology)Plainsboro, NJFor 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.5c143e31-5e48-4549-b638-05792d185386
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 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.
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 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.
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.