li style="width:6.6493in">Prepare the study reference manual, including liaising with the Contract Research Organization (CRO) team (i.e., central lab, specialty labs and vendors) to ensure efficient preparation and delivery of study materials to investigator sites. SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ.
Through clinical trials we ensure that our existing and pipeline products are developed to produce safe, effective, and innovative medicines, and we work with cross-functional colleagues in Global Medical and Scientific Affairs and Global Policy to ensure timely access to our medicines. Establishing communications with prominent clinical investigators in their particular field of interest, particularly those scientifically and operationally strong investigators who can assist in the development of our company's investigational and marketed drugs.
li>Assist the Senior/Executive Director in ensuring that appropriate corporate personnel are informed of the progress of studies of our Company's and competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas of responsibility. Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Oncology drugs; Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; and.
Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the Executive Director and/or Associate Vice President in ensuring that appropriate Corporate personnel are informed of the progress of studies of our company and competitors' drugs, and of internal and external expert opinion on scientific questions relevant to their areas of responsibility. The Senior Director is responsible for maintaining a strong scientific fund of knowledge by:
- Maintaining awareness of scientific developments within their area of expertise, in terms of new scientific findings, research methodologies.
Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the Executive Director in ensuring that appropriate corporate personnel are informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas of responsibility. Required Skills:
Clinical Development, Clinical Medicine, Clinical Research Management, Clinical Studies, Clinical Trial Development, Clinical Trials, Dermatology, Drug Development, Gastroenterology, Inflammatory Bowel Diseases, Pharmaceutical Industry, Regulatory Compliance, Rheumatology.
li>Assist the Executive Director in ensuring that appropriate corporate personnel are informed of the progress of studies of our Company's and competitors' drugs and internal and external expert opinion on scientific questions relevant to their areas of responsibility. The Senior Director is responsible for maintaining a strong scientific fund of knowledge by:
- Maintaining awareness of scientific developments within their area of expertise, in terms of new scientific findings, research methodologies.
Princeton, NJ30+ days ago
Prepare the study reference manual, including liaising with the Contract Research Organization (CRO) team (i.e., central lab, specialty labs and vendors) to ensure efficient preparation and delivery of study materials to investigator sites. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development.
li>Prepare the study reference manual, including liaising with the Contract Research Organization (CRO) team (i.e., central lab, specialty labs and vendors) to ensure efficient preparation and delivery of study materials to investigator sites. CRA is responsible for the management and oversight of their assigned clinical study sites to ensure data quality and patient safety in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs.
Hackensack, NJ30+ days ago
p>The Senior Research Contract Specialist will provide dedicated professional level contractual management in order to facilitate and promote the research endeavors of investigators at Hackensack Meridian Health. At Hackensack Meridian Health we help our patients live better, healthier lives - and we help one another to succeed.
Florham Park, NJ30+ days ago
li>NDP Development - directs, develops, organizes, and implements the HEOR strategy with concurrence of functional management to allow the development of each NDP to proceed expeditiously and smoothly toward registration, PR&A and market launch in compliance with national and international governmental regulations for various programs for multiple Therapeutic Areas. Drive the design and aggressive execution of a high quality HEOR program supporting the therapeutic area strategy for pipeline products as well as on-market products that effectively and efficiently meets ethical, scientific, regulatory, commercial, and quality requirements.
Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. Contribute to the planning and execution of external meetings and internal stakeholder meetings (e.g., Ad Boards, IMs, Governance, DMCs, Regulatory Authority, Dose Escalation meeting); responds to or triages questions for appropriate escalations.
p>The 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:
Orange, New Jersey30+ days ago
As the primary subject matter expert (SME), this leader will collaborate closely with the Vitalief delivery team to design and implement enterprise-level operational initiatives, with a strong emphasis on Non-Oncology programs and enhancing cross-system communication and coordination. IMPORTANT NOTE:Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis..
Morristown, NJ30+ days ago
p>Understanding of pharmaceutical product development and life cycle management gained through ~4 years of clinical development and medical experienceExcellent Scientific and medical / clinical expertiseExcellent expertise in clinical development and methodology of clinical studiesExcellent communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agenciesDemonstrated capability to challenge decision and status quo with a risk-management approachAbility to negotiate to ensure operational resources are available for continued clinical conductFluency in written and spoken EnglishExcellent Teaching skills, demonstrated ability to assist and train othersAbility to work within a matrix modelInternational/ intercultural working skillsOpen-minded to apply new digital solutions. pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment)Contribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authoritiesProvide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigatorsBe the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical dataInteract with other CRDs in the project, Global Project Head, The PV Rep, Regulatory and other key functional reps.
Morris Plains, New Jersey30+ days ago
We are committed to providing our employees with a benefits program that is comprehensive and competitive – including healthcare, wellness, inclusion networks, and continued learning and development offerings. In addition to base pay, Zebra offers this role the opportunity to earn a performance-based annual cash incentive, at a target equal to 10% of base pay, in accordance with the terms of the applicable incentive plan.Zebra
Princeton, NJ30+ days ago
We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. The (Senior) Director, Clinical Research will be a highly qualified and motivated individual who will have a leadership role in the development of Acadia programs for rare diseases and/or neurologic and neuropsychiatric disorders.
Princeton, NJ30+ days ago
For 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.
The Politics Department is seeking a Senior Research Scholar (SRS) to provide advanced research and project management support for a portfolio of research studies focused on Africa, Latin America and South Asia. The University considers factors such as (but not limited to) scope and responsibilities of the position, candidate''s qualifications, work experience, education/training, key skills, market, collective bargaining agreements as applicable, and organizational considerations when extending an offer.
li>Build BDI's state-based partnerships and relationships with key stakeholders representing varying sectors including election protection, racial justice, LGBTQ+ rights, faith-based, government, and others in order to provide monitoring and analysis support across the board and to better inform our research. We do this by 1) producing action-oriented and responsive research to fill existing gaps and empower local leaders; 2) enabling cross-sector collaboration, so individuals and organizations are better prepared to mitigate risk and respond to crisis when it does arise; and 3) helping to drive the policy and community response.
p>Co-authors clinical sections of protocols, clinical investigator brochures, clinical study reports, Worldwide Marketing Application/Common Technical Document (WMA/CTD) subsections, and regulatory agency update and safety reports, as well as clinical development plans, publications, and abstracts. Experience managing Immunology and/or vaccine trials with an ability to think outside of the box, explore novel ways of working and comfortably navigate ambiguity to drive results also a plus.
li>A strong record of scholarly impact such as: publications in leading venues relevant to the role (AI/ML/NLP and/or measurement/education research), recognized contributions to the field (invited talks, editorial/service roles, awards, high-impact collaborations), and/or demonstrated leadership of influential research programs. This position is designed for a distinguished AI researcher who can shape the future of assessment by advancing and applying state-of-the-art approaches in artificial intelligence, machine learning, natural language processing, and/or generative AI to high-stakes educational and workforce measurement.
Red Bank, New Jersey2 days ago
p style="margin-bottom:6pt">Success in this role demands genuine technical depth, sound product judgment about what will most increase the product’s value to customers, and the communication skills to align a team that spans software engineers, domain experts, DoD stakeholders, and end users. Responsibilities: Peraton is seeking a Senior Research Engineer to help drive an established program developing a mature, fielded RF spectrum planning, monitoring, and management system for Department of Defense customers.
Princeton, NJ30+ days ago
Identify solutions for each project, establish a set of applicable best practices for individual or team use that is uniquely appropriate for that project (e.g version control, continuous integration and continuous delivery, software design, programming model, etc.), and enable long term maintainability and sustainability by documenting the projects in a descriptive and appropriately detailed manner. Has a strong command of the research domain with proficient understanding of the underlying science, math, statistics, data analysis, and algorithms of computational research questions at a level sufficient to converse on projects with Princeton's world-class researchers to consistently contribute to the ongoing work.
Essential qualifications:- Experience in a molecular biology lab environment- Experience breeding insects- Experience with CRISPR/Cas9 technology- Good communication skills- Excellent organizational skills and a strong attention to detail- Ability to lead a project independently and problem solve as needed- Ability to work well with others in a team environment- Ability to multi-task and prioritize in an environment with multiple demands and ongoing projects. Primary responsibilities will include assisting and leading research projects involving the development of genetic tools using CRISPR/Cas9 approaches, conducting and analyses animal behavioral experiments, and preparing high-throughput sequencing libraries etc.
p>Any offer of employment may be contingent upon receipt of acceptable results from a post-offer background screening, if required for the specific position, which may include, for example, identity verification, employment history, motor vehicle driving record history, and criminal or sexual offender records history. Westat has an immediate opening for a Research Assistant to contribute to ongoing health research exploring genetic, clinical, and environmental factors influencing cancer in individuals, families, and broader populations.
Our core competencies include pre-clinical, drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Title: Clinical Research Administrative Assistant Location: Secaucus, NJ Reports To: Senior Vice President.
Newark, New Jersey6 days ago
By combining deep subject matter expertise with the experience of senior research practitioners, we help organizations accelerate study activation, optimize operations, improve financial performance, and build scalable workforce solutions that reduce costs, increase efficiency, and advance clinical breakthroughs for patients. IMPORTANT NOTE:Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis..
p>A day in the life of a Clinical Research Nurse at Hackensack Meridian Health includes: - Assists the principal investigator in the preparation of proposed clinical trials by reviewing trial protocol, contacting each department who will provide resources during study and ensuring appropriate departments are notified and given a copy of proposed trial, scientific merit and accrual potential.
The Clinical Research Nurse is responsible for coordinating and overseeing clinical research operations for all assigned clinical trials and participates in assessing, planning, implementing and evaluating Compliant Patient Care in clinical research trials.
Hackensack, New Jersey16 days ago
Responsibilities: A day in the life of a Clinical Research Coordinator at Hackensack Meridian Health includes:
- Acts as liaison between principal investigators, sub-investigators, clinical research nurses and regulatory specialists on all regulatory issues and changes within the protocol.
- Schedules, coordinates, prepares, and assists for all sponsor monitor site visits and ensures all supporting documentation records are adequate and available for the visit; Meets with monitor at least once during each monitor site visit and resolves all issues found during visit.
Piscataway, NJ12 days ago
Aligned with Rutgers University-New Brunswick and collaborating university wide, RBHS includes eight schools, a behavioral health network, and five centers and institutes that focus on cancer treatment and research, neuroscience, advanced biotechnology and medicine, environmental and occupational health, and health care policy and aging research. Under Policy 100.3.1 Immunization Policy for Covered Individuals, if employment will commence during Flu Season, Rutgers University may require certain prospective employees to provide proof that they are vaccinated against Seasonal Influenza for the current Flu Season, unless the University has granted the individual a medical or religious exemption.
MSL will communicate key information about Eisai, the company and its hhc mission; b) provide key scientific and clinical information about Eisai’s products; serve as a conduit for communication between Eisai Research and the medical community regarding ideas for future research with Eisai’s products, and c) provide corporate value through demonstrated leadership and participation in strategic thinking. MSL) is a field-facing representative of US Medical Affairs with a primary responsibility of engaging in the exchange of scientific data and other medical and/or scientific information with external customers (healthcare providers, researchers, professional organization leadership, and population-based decision makers) in the areas of Eisai’s interest.
Hackensack, New Jersey19 days ago
ul>Assists the principal investigator in the preparation of proposed clinical trials by reviewing trial protocol, contacting each department who will provide resources during study and ensuring appropriate departments are notified and given a copy of proposed trial, scientific merit and accrual potential. The Clinical Research Nurse is responsible for coordinating and overseeing clinical research operations for all assigned clinical trials and participates in assessing, planning, implementing and evaluating Compliant Patient Care in clinical research trials.
li>Working closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects, and assist the Associate Vice President and/or Vice President in ensuring that appropriate Corporate personnel are informed of the progress of studies of our company and competitors' drugs, and of internal and external expert opinion on scientific questions relevant to their areas of responsibility.
Leading internal governance presentations to senior management and committees, communicating progress and key changes in product development strategy between stage gates, ensuring early alignment with line management, and facilitating issue escalation and cross-functional collaboration as needed for governance approval.
p>RWJBarnabas Health is the premier health care destination providing patient-centered, high-quality academic medicine in a compassionate and equitable manner, while delivering a best-in-class work experience to every member of the team. Driven by our Total Wellbeing promise, our market-competitive offerings include comprehensive benefits and resources to support our employees' physical, emotional, financial, personal, career, and community wellbeing.
The system delivers primary care to more than 150,000 patients in Connecticut, and extends access to specialty care for more than 2.5 million individuals across the U.S. It is a national accrediting body for organizations training advanced practice providers, and offers accredited education and training for Medical Assistants in multiple states. As an incubator for new ideas in areas including social justice, the environment, and social determinants of health, the MWHS is addressing challenges faced by providers caring for underserved communities, creating innovative and impactful initiatives led by nationally and internationally recognized experts.
Under Policy 100.3.1 Immunization Policy for Covered Individuals, if employment will commence during Flu Season, Rutgers University may require certain prospective employees to provide proof that they are vaccinated against Seasonal Influenza for the current Flu Season, unless the University has granted the individual a medical or religious exemption. Posting Open Date 06/03/2026 Posting Close Date 09/01/2026 Open Until Filled No Special Instructions to Applicants Regional Campus Rutgers University-Newark Home Location Campus Rutgers University-Newark City Newark State NJ Location Details.