Clinical Research

• Devising the clinical pharmacology and model informed drug development strategy via application of quantitative methods to integrate knowledge of nonclinical data (e.g., metabolism, BCS classification, pharmacology, safety), PK, PD (e.g., biomarker, efficacy, and/or safety), patient characteristics, disease states, competitive landscape, and drug interactions to influence go/no go decisions, support sub-population, dose and dosage regimen selection, and optimize study designs throughout drug development.
• Translate quantitative knowledge into strategic opportunities to influence development along the model-informed drug development principles.
• Planning and performing, or providing oversight, for appropriate analyses (e.g., non-compartmental, population and/or modelling and simulation analysis of PK and/or PD data) of preclinical-clinical translation and dose/exposure-response relationships, to guide dose regimen and optimize study design.
• Planning, summarization and interpretation of results of PK and PK/PD analyses with respect to their impact on a development program and clinical use.
• Planning and delivery of scientifically robust and efficient clinical pharmacology strategies for development candidates.
• Carries out functional responsibilities in accordance with applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.
• Planning, conducting, and/or providing oversight of PK and PK/PD analyses and reporting.
• Devising clinical pharmacology strategy including design of Phase I clinical pharmacology studies and/or use of alternate modeling approaches, consistent with regulatory guidelines.
• Managing and/or supervising elements of CPP studies.
• Developing key product differentiation strategies based on a compound’s key attributes and relevant therapeutic landscape.
• Defining regulatory strategy for CPP and prepare CP contributions to regulatory documents including IBs, IND’s, briefing books, submission packages, responses to health authority questions, and other regulatory documents.
• Represent CP in relevant external regulatory meetings (e.g., End of Phase 2, pre-NDA / MAA, Advisory Committee meetings).
• Participating in the evaluation of potential business development opportunities.
• Contributing to the knowledge of clinical pharmacology, model informed drug development, analysis methodology and overall drug development process, including regulatory guidance, and methods in modelling and simulation by engaging with the scientific community (e.g., publishing, presenting at meetings, participating in special interest groups within professional societies, etc.) and identify new opportunities for applied scientific and technical advancement within the department.
• Working effectively in team environments, managing CP deliverables in accordance with timelines and overall project goals.

Principal Scientist, Clinical Pharmacology – Pharmacometrics

• Lead health outcomes and health services research projects from concept through delivery, applying sound research design, statistical methods, and evidence-based approaches
• Translate complex clinical and analytical findings into clear, compelling manuscripts, presentations, reports, and other communications tailored to healthcare professionals, policymakers, patients, and business stakeholders
• Conduct literature reviews and background research to strengthen study design, support strategic recommendations, and provide context for research findings
• Partner with analytics, clinical, and cross-functional teams to answer important healthcare questions and evaluate the clinical and financial impact of products, programs, and services
• Analyze large healthcare datasets to generate actionable insights, identify trends, and support enterprise research priorities
• Serve as a project lead or key contributor across multiple initiatives, ensuring high-quality deliverables and timely execution
• Communicate research findings and recommendations to diverse audiences, helping stakeholders understand complex data and make informed decisions
• Contribute to a culture of innovation, continuous learning, and collaboration while adapting to evolving business needs

Senior Business Analytics Advisor – Clinical & Health Outcomes Research

• Key member of an early development team, providing leadership in designing and executing early clinical development strategy
• Development and execution of early clinical strategy for novel therapeutics including authoring initial clinical and biomarker plans for Lead Optimization programs
• Development and execution of studies to validate clinical platforms utilizing established and novel biomarkers
• Provide clinical expertise for identification and validation of novel targets
• Safe and timely execution of Phase I studies
• Provide clear, timely communication and interpretation of study results to therapeutic area governance
• Contribute to assessment of internal and external opportunities identified by Business Development and Licensing
• Interface broadly with key functions throughout research sites around the world

Principal Scientist, Clinical Research

• Serve as the CSS therapeutic area lead for the vaccine and infectious disease (VID) projects
• Provide statistical leadership and support to the Risk Management and Safety Teams (RMSTs) in the strategic planning and execution of compound level safety evaluation across product life cycle in vaccine and drug programs
• Design, develop and implement innovative statistical methods and tools for safety evaluation
• Partner with Clinical Safety Risk Management, Early/Late Development Statistics, Epidemiology, Programming, and other RMST functions to plan and execute on aggregate safety evaluation in vaccine and drug projects
• Ensure safety deliverables meet analysis requirements, relevant SOPs and regulatory guidance
• Communicate safety-analysis results and recommendations to teams, management, regulators, and investigators
• Develop processes, job aids, statistical methods, and tools for safety evaluation that address scientific and business needs

Principal Scientist, Biostatistics – Clinical Safety Statistics

• Support the design and execution of multiple clinical studies across the development plan
• Help prepare key trial documents — protocols, informed consent forms, and benefit-risk assessments
• Contribute to CRF design and review completion instructions
• Support study start-up, site opening, and enrollment monitoring
• Review and analyze data listings, patient profiles, and key study data within statistical reports
• Partner with Data Management to generate relevant queries
• Stay current on competitive data and the therapeutic landscape
• Deliver clinical landscape and benchmark updates to the CRD and Project Lead
• Partner with Clinical Leads and CRDs to build presentations for governance committees
• Serve as delegate for the CRD in developing and overseeing the clinical development plan
• Act as liaison across data management, biostatistics, medical writing, pharmacovigilance, regulatory affairs, clinical operations, and translational medicine
• Support project team members, project management, and medical affairs
• Co-author briefing packages for health authority submissions and contribute to regulatory strategy
• Build and maintain relationships with internal collaborators, KOLs, and investigators
• Support interactions with Sanofi governance bodies, external partners, and committees

Senior Clinical Scientist

• Provides strategic input as the lead statistical subject matter expert supporting clinical research studies
• Leads or oversees statistical analyses and application of advanced research methods
• Contributes statistical expertise to research proposals, grant-supported initiatives, protocol development, and scientific publications
• Publishes research findings in recognized scientific publications

Principal Biostatistician

• Manage clinical trial programs/projects from one or multiple clients
• Provide day to day technical and operational leadership to project teams
• Provide statistical oversight on projects in the assigned drug development programs/projects
• Ensure sound statistical methodologies in study design, sample size estimation, statistical analysis planning, and reporting
• Coach, mentor, develop, and provide technical review and advice to less experienced Biostatisticians and Statistical Programmers
• Participate in the writing of trial protocols and research proposals
• Review and provide input to clinical data management deliverables
• Write Statistical Analysis Plans, Statistical Reports
• Perform overall Quality Control review on statistical deliverables
• Ensure compliance with relevant regulatory requirements
• Interact with regulatory agencies and support sponsor in new drug applications

• publish content on external website (dcri.org) and intranet (Pulse) using content management systems (Drupal and SharePoint, respectively)
• create graphics for social media, external websites, and intranet
• determine requirements for instructional audiovisual media and coordinate production of slide series, films, videotapes and other media materials for use
• works both independently and collaboratively with internal Shared Services department, Production Designers and Marketing Managers on a wide mix of creative initiatives
• manage calendar of DCRI’s scientific conferences, researching Duke-related presentations at each show
• for scientific conferences at which DCRI has an exhibit booth, coordinate the marketing collateral needed for the booth
• prepares layouts, designs, artwork and formats for use in publication and/or exhibition design
• contribute to editorial planning by suggesting content ideas, target channels and audiences, and appropriate project timelines
• compile weekly internal newsletter in MS Outlook
• create quarterly external-facing newsletters using Constant Contact
• occasional content development for DCRI-owned external and internal channels
• serve as backup manager of DCRI’s social media channels (Twitter and LinkedIn)
• assist in the shooting and production of video and audio projects
• develop a broad knowledge of research conducted at the DCRI

Clinical Research Comm Specialist III

• responsible for the successful execution, enrollment and quality of clinical trial portfolio
• develop operational strategies and quality plans for all programs and studies
• collaborate with other TA directors, local and regional stakeholders
• ensure oversight and line management of Clinical Research Manager (CRM) team
• lead a team to high performance and accountable for CRM performance reviews.

Clinical Research Manager – Lead

• Manage studies to provide safety and efficacy data for regulatory approval of drugs
• Ensure high-quality clinical trials integrating state-of-the-art technology and rigorous ethical standards
• Primary responsibility for planning and directing clinical research activities in Thoracic Oncology
• Manage the entire cycle of clinical development including strategy, study design, execution, monitoring, analysis, and reporting
• Provide scientific leadership and collaborate with cross-functional teams
• Interact externally with key opinion leaders and maintain awareness of scientific developments

Distinguished Scientist, Clinical Research, Thoracic Malignancies

• responsible for the planning and directing of clinical research activities involving new or marketed medicines in the Oncology therapeutic area, Hematology section
• manage and oversee the entire cycle of late-stage clinical development from Phase 2 to Phase 5
• lead cross-functional product development teams that oversee program strategy and execution
• provide internal scientific leadership for cross-functional areas supporting clinical trials
• interact externally with key scientific leaders
• evaluate pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug (IND) applications
• develop clinical development strategies for investigational or marketed medicines
• monitor and manage the conduct of ongoing or new clinical trials for investigational or marketed medicines
• act as an integration of cross-functional input and expertise
• analyze and summarize the clinical findings from studies to support decisions regarding safety and efficacy

Executive Director, Product Development Team Leader, Clinical Research – Hematology, Lymphoma

• Responsible for implementation, planning, and execution of assigned clinical trial activities.
• Serves as Clinical Trial Lead for one or more trials.
• Successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervision.
• Provides scientific and clinical leadership to team of supporting Clinical Scientists (matrix leadership).
• Co-Leads study team meetings in partnership with GDO protocol manager; and collaborate with cross functional study team members.
• May support clinical development planning (collaboration with Clinical Development Lead/Clinical Trial Physician for provision and analysis of data to support future planning).
• Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members.
• Plan and lead the implementation all study startup/conduct/close-out activities as applicable.
• Evaluate innovative trial designs (collaboration with Medical Monitor/Clinical Development Lead).
• Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing).
• Site-facing activities such as training and serving as primary contact for clinical questions.
• Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team.
• Clinical data trend identification; provide trends and escalate questions to Medical Monitor.
• Develop clinical narrative plan; review clinical narratives.
• Provision of information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
• Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities.
• Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses).
• Collaborate and serve as primary liaison between external partners for scientific advice.

Associate Director, Global Clinical Scientist – Cell Therapy

• Collaborate and liaise with external partners (e.g., KOLs).
• Seek out and enact best practices with instruction.
• Provide regular and timely updates to manager/management as requested.
• Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required.
• Conduct literature review.
• Submit clinical documents to TMF.
• Develop site and CRA training materials and present these at SIVs and Investigator meetings.
• Review clinical narratives.
• Monitor clinical data for specific trends.
• Develop Data Review Plan in collaboration with Data Management.
• Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
• Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.)

Senior Manager, Global Clinical Scientist – Psychiatry

• planning and directing of clinical research activities involving new or marketed Oncology medicines
• manage the entire cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication
• evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications
• developing of clinical development strategies for investigational or marketed Oncology drugs
• planning clinical trials (design, operational plans, settings) based on these clinical development strategies
• 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
• participating in internal and joint internal/external research project teams relevant to the development of new compounds and the further study of marketed compounds

Senior Principal Scientist, Clinical Research, GI

• Provide strategic HCC leadership, oversight and execution of the G lobal Health Care Compliance program for R& D, Clinical Research, Medical Affairs, and related activities.
• Act as a compliance partner and trusted advisor to G lobal R&D, Clinical Research and Medical Affairs teams, providing timely , practical guidance on clinical trials, investigator and site interactions, advisory boards, and scientific exchange.
• Assist in identifying , assessing, and mitigating compliance risks associated with clinical research activities and medical engagement models.
• Support compliance risk assessments, issue management, and monitoring activities related to R&D, Clinical Research and Medical Affairs.
• Collaborate with Legal, Privacy, Quality, Finance, and other assurance functions to deliver coordinated compliance support and risk mitigation.
• Contribute to the development, implementation, and maintenance of policies, procedures, and training materials related to R&D, Clinical Research and Medical Affairs compliance.
• Support responses to internal inquiries, audits, monitoring activities, and regulatory requests related to clinical and medical compliance topics.

Clinical Research Manager, Medical Affairs

• Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans)
• Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place
• Contribute to the development of the project risk mitigation plan. Manage clinical risks through the project lifecycle
• Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues
• Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver
• Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work
• Work as the primary Clinical Lead alongside other Clinical Leads to deliver large, global trials
• Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management
• Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements
• Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings
• Conduct regular team meetings and communicate appropriately to achieve objectives
• Support professional development by providing feedback to clinical team line managers on performance relative to project tasks to support professional development
• Adopt corporate initiatives and changes and serve as a change advocate when necessary
• May contribute to the development of the clinical delivery strategy for business proposals. Participate in bid defense preparations and meetings
• Develop and present Clinical Operation plan in partnership with Business Development and Project Leadership
• May mentor and coach new peers as they assimilate into this role
• May attend site visits as applicable in support of project delivery

Senior Clinical Trial Manager

• Lead in the development, evaluation, planning and execution of clinical studies
• Ensures scientific integrity and interpretation of study data of a clinical development program
• Collaborates closely with Medical Director (MD) to provide scientific expertise
• Develops/maintains proficient understanding of therapeutic disease area(s) and drug candidate
• Applies basic scientific expertise to support initiation and execution of clinical research and development studies for early and/or late-stage assets
• Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings
• Assists with development of the Expanded Synopsis and may author clinically relevant sections

Manager, Clinical Scientist, Hematology

• Managing and directing clinical research activities involving new or marketed drugs in the Oncology Clinical Research group and in the field of Thoracic Oncology.
• Managing the entire cycle of clinical development, including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meetings.
• Provide internal scientific leadership for cross-functional areas supporting clinical trials and interact externally with key opinion leaders.
• Evaluating pre-clinical and translational work for generating early clinical development plans and Investigational New Drug applications.
• Developing clinical development strategies for investigational or marketed agents that incorporate the latest scientific developments, regulatory requirements, competitive landscape, and commercial considerations.
• Planning clinical trials based on these strategies.
• Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed agents.
• Analyzing and summarizing clinical findings to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publications.
• Participation in internal and joint research project teams relevant to the development of new compounds and the further study of marketed compounds.

• lead the clinical trial strategy for multiple myeloma assets
• create synergies across Clinical Operations, Biostatistics, Regulatory, Translational Medicine, Project Management, New Product Planning and Pharmacovigilance
• author protocols, extended synopses, clinical sections of the Investigator Brochure, IND/IMPD fillings, annual reports
• provide expert medical guidance to other functions
• present and discuss development strategy and clinical study results with key stakeholders

Senior Clinical Research Director – Oncology

• Responsible for the development, execution and reporting of clinical trials in support of the registration of a product
• Development of abbreviated protocol and clinical protocol
• Participation in the review process for protocols, study reports, labeling, and interactions with regulatory agencies and ethics committees
• Drive breakthroughs that could turn the impossible into possible for millions
• Ensure that all development activities are targeted towards timely achievement
• Interact with opinion leaders and external consultants
• Serve as medical monitor for the studies assigned
• Ensure clinical data meets all necessary regulatory standards

Clinical Research jobs in New Jersey

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Principal Scientist, Clinical Pharmacology – Pharmacometrics

Senior Business Analytics Advisor – Clinical & Health Outcomes Research

Principal Scientist, Clinical Research

Principal Scientist, Biostatistics – Clinical Safety Statistics

Senior Clinical Scientist

Principal Biostatistician

Principal Biostatistician

Clinical Research Comm Specialist III

Clinical Research Manager – Lead

Distinguished Scientist, Clinical Research, Thoracic Malignancies

Executive Director, Product Development Team Leader, Clinical Research – Hematology, Lymphoma

Associate Director, Global Clinical Scientist – Cell Therapy

Senior Manager, Global Clinical Scientist – Psychiatry

Senior Principal Scientist, Clinical Research, GI

Clinical Research Manager, Medical Affairs

Senior Clinical Trial Manager

Manager, Clinical Scientist, Hematology

Distinguished Scientist, Clinical Research, Thoracic Malignancies

Senior Clinical Research Director – Oncology

Clinical Research Director – Immunology and Inflammation