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, 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).
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
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 - Clinical Education - Trenton - PER DIEM Capital HealthClinical Research Coordinator - Clinical Education - Trenton - PER DIEMPennington, NJ$86,964.80–$119,714.81 / yearWhen determining base salary and/or rate, several factors may be considered including, but not limited to location, years of relevant experience, education, credentials, negotiated contracts, budget, market data, and internal equity. Capital Health is a dynamic health care resource accredited by the DNV that includes two hospitals, an outpatient center, satellite ED, and an expansive network of primary and specialty care.
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 Practice Coordinator - Clinical Education - Trenton - Full-Time - DAYS Capital HealthClinical Practice Coordinator - Clinical Education - Trenton - Full-Time - DAYSPennington, NJ$94,556.80–$124,176 / yearOccasional physical demands include: Standing, Climbing (e.g., stairs or ladders), Carry objects, Push/Pull, Twisting, Bending, Reaching forward, Reaching overhead, Squat/kneel/crawl, Taste or Smell. When determining base salary and/or rate, several factors may be considered including, but not limited to location, years of relevant experience, education, credentials, negotiated contracts, budget, market data, and internal equity.
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.
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.
NewClinical Research Manager (CRM) Lead - Oncology/Early Development Merck & Co IncClinical Research Manager (CRM) Lead - Oncology/Early DevelopmentRahway, NJ$142,400–$224,100 / yearLeads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTCs, CRAs and COMs). Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
Senior Clinical Research Associate Protagonist TherapeuticsSenior Clinical Research AssociateNewark, New JerseySupport study vendor management by performing key activities as delegated by study CTM, including but not limited to: Participate in evaluation of new vendors (CROs, labs, central readers, EDC, etc.) by drafting and/or reviewing RFPs, analyzing responses and drafting work orders for select vendors • Manage the day to day interactions with select study vendor(s), such as a central or specialty lab including developing training materials, lab manuals and acting as first point of contact for issue and query escalation and resolution. Yes, up to 10% Core Responsibilities Overall Study Execution Part of the clinical study team and takes a lead on execution by performing key activities as delegated by the Clinical Study lead, including but not limited to: Develop and/or review key study operational documents (e.g., study reference manual, laboratory and pharmacy manuals, data management plan, query generation, monitoring plan; review site audit reports) •.
On-site Clinical Research Associate Protagonist TherapeuticsOn-site Clinical Research AssociateNewark, New JerseyThe Company also has a number of clinical and preclinical programs based on clinically and commercially validated targets and addressing unmet medical needs, including an oral IL-17 antagonist peptide, anti-obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin discovery programs. Clinical Research Associate About Us Protagonist Therapeutics is a biopharmaceutical company built on a proprietary peptide technology platform that has now produced two FDA-approved, first-in-class medicines, generating royalties and milestones from global commercial partnerships with Johnson and Johnson and Takeda Pharmaceutical Company Limited.
Clinical Laboratory Scientist Clinical Lab Prime Healthcare Services IncClinical Laboratory Scientist Clinical LabPassaic, NJEach individual performing the above procedures must: 1) adhere to the laboratorys procedures for the collection, processing, analysis, and reporting of patient test results, 2) follow the laboratorys established quality control policies and procedures in documenting all corrective actions taken when test systems deviate from the laboratorys established performance specifications, 3) be capable of identifying problems that may adversely affect test performance and either correct the problem or immediately notify your immediate supervisor, Director, or Medical Director, 4) perform a wide variety of laboratory procedures requiring independent judgment using both manual and automated methods in Hematology, Blood Bank, Chemistry, Urinalysis, Coagulation, Microbiology, Immunology, and any other discipline as introduced into the laboratory, 5) perform and document maintenance daily, weekly, monthly, or as needed on instruments and equipment as appropriate, 6) review the accuracy of patient results prior to releasing or reporting, 7) recognize age specific differences in expected results for newborns to geriatrics, 8) ensure that the testing of proficiency testing samples are tested in the same manner as patient samples and that collaboration with other laboratories is prohibited prior to the reporting of proficiency testing results to the appropriate agencies, 9) may be required to perform venipuncture or capillary puncture on various age groups from newborn to geriatrics, 10) assist in the development and maintenance of laboratory policies and procedures, 11) adheres to all department and hospital policies and procedures related to safety, infection control, emergency preparedness, and human resources, 12) 12) in the absence of a supervisor, may be assigned/identified as Lead Tech, having responsibility for the section or department during their shift, 13) may be assigned responsibilities related to LIS and/or POCT. The exact starting compensation to be offered will be determined at the time of selecting an applicant for hire, in which a wide range of factors will be considered, including but not limited to, skillset, years of applicable experience, education, credentials and licensure.