NewClinical Manager - NP/PA BioTalentClinical Manager - NP/PAStaten Island, NY$125,000 / yearFull timeWe’re looking for a Nurse Practitioner or Physician Assistant to join a leading clinical research organization and take on a hybrid clinical + site management role. Are you an experienced NP or PA with strong clinical leadership and clinical research experience?
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.
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.
NewExecutive Medical Director, Clinical Development - M.D. (Nephrology) Clinical Dynamix, Inc.Executive Medical Director, Clinical Development - M.D. (Nephrology)Jersey City, NJThe Clinical Development Executive Medical Director is the clinical leader of the specific clinical programs assigned with responsibility for outlining the overall clinical development strategy in line with regulatory requirements and sound scientific rationale, designing the clinical protocols, guiding the Clinical Operations team towards the adequate implementation of such protocols, ensuring adequate medical monitoring activities are implemented for the conduction of clinical studies and analyzing the data from the clinical program. The individual will also be responsible for ensuring adequate implementation of the global safety surveillance and pharmacovigilance for the investigational products, including review and analysis of safety data from clinical trials and other permitted sources (e.g., early access/expanded access programs, if applicable), identification and investigation of safety signals, and management of the benefit-risk profile for assigned compounds.
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.
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.
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).
NewRegistered Clinical Dietitian - NEW GRADUATES WELCOME TO APPLY! Matheny Medical and Educational CenterRegistered Clinical Dietitian - NEW GRADUATES WELCOME TO APPLY!Peapack, NJ$62,325–$74,790 / yearWhen determining a team member’s base salary and/or rate, several factors may be considered as applicable (e.g., location, specialty, service line, years of relevant experience, education, credentials, negotiated contracts, budget and internal equity). Founded by Walter and Marquerite Matheny in 1951, the Matheny of today is a pioneer in providing fully integrated, personalized care and education that respects each person's dignity and encourages their highest potential.
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.
Research Associate 5PY IQVIA RDS Inc.Research AssociateLake Hiawatha, NJ$47,400–$169,300 / yearEnsure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements. • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Senior Clinical Director, Clinical Research, Hematology Merck & Co IncSenior Clinical Director, Clinical Research, HematologyRahway, NJ$282,200–$444,200 / yearThe Senior Clinical Director (Senior Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed medicines in the Oncology therapeutic area, specifically in our Hematology Section. The Senior Director is responsible for maintaining a strong scientific fund of knowledge by: Maintaining awareness of scientific developments within his/her area of expertise, in terms of new scientific findings, research methodologies.
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.
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 Trials Registered Nurse, Clinical Research Trials, Full Time, Day The Valley HospitalClinical Trials Registered Nurse, Clinical Research Trials, Full Time, DayParamus, New JerseyTo coordinate and implement clinical research protocols under the direction of the Director of Oncology Clinical Trials and Research Compliance, provide care to all or some of the patient's enrolled in each protocol, act as the patient advocate by assuring the safety, consistency, and accuracy of the treatment regimen as dictated by the protocol, and coordinate all nursing activities specifically related to the implementation of the treatment regimen. Must demonstrate effective oral and written communication skills, including speech clarity, understanding the information relayed, deductive and inductive reasoning skills (the ability to apply general rules to specific problems to produce answers that make sense and the ability to combine pieces of information to/from general rules or conclusion respectively).
Clinical Research Coordinator Frontage Clinical Services IncClinical Research CoordinatorSecaucus, NJ$50,000–$52,000 / yearThe Clinical Research Coordinator is required to perform study procedures, to generate, evaluate, review and record study data, to transcribe source data to case report forms, to liaise with sponsor personnel, to maintain a high level of professional expertise through familiarity with the study protocol, investigator's brochure, and related study materials, and to participate in project team meetings. Position/Job Summary: Responsible for working under the guidance of the Principal Investigator and Sub-Investigators, and Clinic Operations to participate in the planning, implementation and overall direction of clinical research trials conducted on behalf of sponsors at the Frontage Clinical Services, Inc.
Clinical Research Associate (CRA) - Cardiovascular/Vaccine/Infectious Disease- Remote Merck & Co IncClinical Research Associate (CRA) - Cardiovascular/Vaccine/Infectious Disease- RemoteRahway, NJRemote$96,200–$151,400 / yearRequired Skills: Adverse Event Reporting System, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Core Competencies, Data Analysis, Data Reporting, Early Clinical Development, Policy Development, Preventive Action, Protocol Adherence, Regulatory Compliance, Site Management. Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
Clinical Research Associate (CRA) - Immunology-Remote Merck & Co IncClinical Research Associate (CRA) - Immunology-RemoteRahway, NJRemote$96,200–$151,400 / yearRequired Skills: Adverse Event Reporting System, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Core Competencies, Early Clinical Development, Policy Development, Preventive Action, Protocol Adherence, Regulatory Affairs Compliance, Regulatory Compliance, Site Management, Training Team Members. Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
Operations Director, Clinical Laboratory Operations - Clinical Laboratory Administration - Tri State Area (New York, New Jersey, Connecticut) - Full Time/Day Shift Mount Sinai Health SystemOperations Director, Clinical Laboratory Operations - Clinical Laboratory Administration - Tri State Area (New York, New Jersey, Connecticut) - Full Time/Day ShiftNewark, NJMount 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.
Associate Clinical Programmer - Clinical Data Operations Novartis AGAssociate Clinical Programmer - Clinical Data OperationsEast Hanover, NJ$27,900–$51,900 / yearRead our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdfNote : Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. Expected Annual Base Salary Range for role: € 27,900.00 - 51,900.00 The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.
Director, Global Clinical Physician - Early Clinical Development Oncology Bristol-Myers Squibb CoDirector, Global Clinical Physician - Early Clinical Development OncologyMadison, NJ$308,700–$374,075 / yearDesigns and develops clinical studies and research plans in support of asset strategy with the Early Clinical Development Leadership team; clinical studies include first-in-human Phase I, proof of concept Phase I/II, entry registrational studies, biomarker qualification studies, and/or clinical pharmacology studies. Serves as an independent Medical Monitor for clinical trials from Phase 1 through Proof-of-Concept by: Articulating clinical development strategy, Analyzing, interpreting, and acting on clinical trial data to support development, Serving as principal functional author for Regulatory submission, study reports, and publications.